Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

[1]  J. Kastelein,et al.  Clinical, Diagnostic, and Therapeutic Aspects of Familial Hypercholesterolemia , 2004, Seminars in vascular medicine.

[2]  Min-Ying Su,et al.  Monitoring the Size and Response of Locally Advanced Breast Cancers to Neoadjuvant Chemotherapy (Weekly Paclitaxel and Epirubicin) with Serial Enhanced MRI , 2003, Breast Cancer Research and Treatment.

[3]  J E Husband,et al.  Evaluation of the response to treatment of solid tumours – a consensus statement of the International Cancer Imaging Society , 2004, British Journal of Cancer.

[4]  V. Ambrosini,et al.  Conventional and novel PET tracers for imaging in oncology in the era of molecular therapy. , 2008, Cancer treatment reviews.

[5]  P. Bruzzi,et al.  Presurgical systemic treatment of nonmetastatic breast cancer: facts and open questions. , 2008, The oncologist.

[6]  Geert Molenberghs,et al.  Information-theory based surrogate marker evaluation from several randomized clinical trials with continuous true and binary surrogate endpoints , 2007, Clinical trials.

[7]  P. Durrington.  Triglycerides are more important in atherosclerosis than epidemiology has suggested. , 1998, Atherosclerosis.

[8]  J. Wittes,et al.  Surrogate endpoints in clinical trials: cardiovascular diseases. , 1989, Statistics in medicine.

[9]  A. Jaffe,et al.  Myocardial injury in critically ill patients : a frequently unrecognized complication , 1995 .

[10]  A. Jaffe,et al.  Troponin: the biomarker of choice for the detection of cardiac injury , 2005, Canadian Medical Association Journal.

[11]  N. Stockbridge,et al.  Blood pressure as an example of a biomarker that functions as a surrogate , 2006, The AAPS Journal.

[12]  G. Lip,et al.  The prognostic value of biomarkers after a premature myocardial infarction. , 2010, International journal of cardiology.

[13]  K. Kayaba,et al.  Distribution of serum C-reactive protein and its association with atherosclerotic risk factors in a Japanese population : Jichi Medical School Cohort Study. , 2001, American journal of epidemiology.

[14]  C. Rigatto,et al.  Biomarkers and surrogates in clinical studies. , 2009, Methods in molecular biology.

[15]  M. Ratain,et al.  Development of Target-Based Antineoplastic Agents , 2000, Investigational New Drugs.

[16]  H. Matsubara,et al.  The association between cholesterol and mortality in heart failure. Comparison between patients with and without coronary artery disease. , 2005, International heart journal.

[17]  R. Krauss,et al.  Predominance of large LDL and reduced HDL2 cholesterol in normolipidemic men with coronary artery disease. , 1995, Arteriosclerosis, thrombosis, and vascular biology.

[18]  R. Platt,et al.  The new Sentinel Network--improving the evidence of medical-product safety. , 2009, The New England journal of medicine.

[19]  P. Libby,et al.  Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. , 2008, The New England journal of medicine.

[20]  D. DeMets,et al.  Surrogate End Points in Clinical Trials: Are We Being Misled? , 1996, Annals of Internal Medicine.

[21]  R. Prentice.  Surrogate and mediating endpoints: current status and future directions. , 2009, Journal of the National Cancer Institute.

[22]  P. Maciejewski,et al.  Lipid profile during the first 24 hours after myocardial infarction has significant prognostic value. , 2004, Kardiologia polska.

[23]  E. Barrett-Connor,et al.  Minimally elevated cardiac troponin T and elevated N-terminal pro-B-type natriuretic peptide predict mortality in older adults: results from the Rancho Bernardo Study. , 2008, Journal of the American College of Cardiology.

[24]  R. Prentice.  Surrogate endpoints in clinical trials: definition and operational criteria. , 1989, Statistics in medicine.

[25]  Choosing the best endpoint. , 2008, Journal of hepatology.

[26]  E. Braunwald,et al.  Ability of minor elevations of troponins I and T to predict benefit from an early invasive strategy in patients with unstable angina and non-ST elevation myocardial infarction: results from a randomized trial. , 2001, JAMA.

[27]  J. Danesh,et al.  C‐reactive protein and coronary heart disease: a critical review , 2008, Journal of internal medicine.

[28]  Gordon H Guyatt,et al.  Association between change in high density lipoprotein cholesterol and cardiovascular disease morbidity and mortality: systematic review and meta-regression analysis , 2009, BMJ : British Medical Journal.

[29]  D. Needham,et al.  Troponin I and T levels in renal failure patients without acute coronary syndrome: a systematic review of the literature. , 2004, The Canadian journal of cardiology.

[30]  Paul T. Williams,et al.  Ion Mobility Analysis of Lipoprotein Subfractions Identifies Three Independent Axes of Cardiovascular Risk , 2009, Arteriosclerosis, thrombosis, and vascular biology.

[31]  G A Beller,et al.  Demographics and cardiology, 1950-2050. , 2000, Journal of the American College of Cardiology.

[32]  M. Nahata,et al.  Cardiotoxicity of Chemotherapeutic Agents , 2000 .

[33]  D. Gordon,et al.  High-density lipoprotein--the clinical implications of recent studies. , 1989, The New England journal of medicine.

[34]  P. Allhoff,et al.  Helsinki Heart Study: Primary-Prevention Trial with Gemfibrozil in Middle Aged Men with Dyslipidemia , 1991 .

[35]  P. Bouillet,et al.  Chemotherapy response evaluation in metastatic colorectal cancer with FDG PET/CT and CT scans. , 2009, Anticancer research.

[36]  N. Freemantle,et al.  Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis. , 2006, The Lancet. Oncology.

[37]  W. Maisel,et al.  Premarket Clinical Evaluation of Novel Cardiovascular Devices: Quality Analysis of Premarket Clinical Studies Submitted to the Food and Drug Administration 2000–2007 , 2010, American journal of therapeutics.

[38]  Nancy R Cook,et al.  Advances in Measuring the Effect of Individual Predictors of Cardiovascular Risk: The Role of Reclassification Measures , 2009, Annals of Internal Medicine.

[39]  P. Prorok,et al.  Development Tracks for Cancer Prevention Markers , 2004, Disease markers.

[40]  Rajeshwari Sridhara,et al.  Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues , 2008, Statistical methods in medical research.

[41]  Nola Hylton,et al.  MR imaging for assessment of breast cancer response to neoadjuvant chemotherapy. , 2006, Magnetic resonance imaging clinics of North America.

[42]  C. Hudis.  Clinical implications of antiangiogenic therapies. , 2005, Oncology.

[43]  T. Lumley,et al.  Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs. , 2008, JAMA.

[44]  Robin Henderson,et al.  Identification and efficacy of longitudinal markers for survival. , 2002, Biostatistics.

[45]  C. Herzog,et al.  Cardiac troponin T and C-reactive protein for predicting prognosis, coronary atherosclerosis, and cardiomyopathy in patients undergoing long-term hemodialysis. , 2003, JAMA.

[46]  P. Bachorik,et al.  National Cholesterol Education Program recommendations for measurement of low-density lipoprotein cholesterol: executive summary. The National Cholesterol Education Program Working Group on Lipoprotein Measurement. , 1995, Clinical chemistry.

[47]  M. Citron.  Dose Density in Adjuvant Chemotherapy for Breast Cancer , 2004, Cancer investigation.

[48]  B. Pau,et al.  Circulating cardiac troponin I in severe congestive heart failure. , 1997, Circulation.

[49]  L. Lesko,et al.  Use of biomarkers from drug discovery through clinical practice: Report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development , 2003, Clinical pharmacology and therapeutics.

[50]  P. Hermanek,et al.  Magnetic resonance imaging (MRI)-based indication for neoadjuvant treatment of rectal carcinoma and the surrogate endpoint CRM status , 2008, International Journal of Colorectal Disease.

[51]  W. Colburn.  Selecting and Validating Biologic Markers for Drug Development , 1997, Journal of clinical pharmacology.

[52]  Geert Molenberghs,et al.  Prentice's Approach and the Meta‐Analytic Paradigm: A Reflection on the Role of Statistics in the Evaluation of Surrogate Endpoints , 2004, Biometrics.

[53]  J. Oram.  Novel approaches to treating cardiovascular disease: lessons from Tangier disease , 2001, Expert opinion on investigational drugs.

[54]  Michael Walter,et al.  Interrelationships among HDL metabolism, aging, and atherosclerosis. , 2009, Arteriosclerosis, thrombosis, and vascular biology.

[55]  A. Rissanen,et al.  Serum antioxidant vitamins and risk of cataract. , 1992, BMJ.

[56]  Susan Halabi,et al.  Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[57]  L. Voipio‐Pulkki,et al.  Degradation of cardiac troponin I: implication for reliable immunodetection. , 1998, Clinical chemistry.

[58]  P. Ridker,et al.  Comparison of LDL cholesterol concentrations by Friedewald calculation and direct measurement in relation to cardiovascular events in 27,331 women. , 2009, Clinical chemistry.

[59]  S. Nissen.  ENHANCE and ACCORD: Controversy over surrogate end points , 2008, Current cardiology reports.

[60]  W. Colburn.  Optimizing the Use of Biomarkers, Surrogate Endpoints, and Clinical Endpoints for More Efficient Drug Development , 2000, Journal of clinical pharmacology.

[61]  M. Cowles.  Bayesian estimation of the proportion of treatment effect captured by a surrogate marker , 2002, Statistics in medicine.

[62]  J. Brody,et al.  FACTORS ASSOCIATED WITH AGE-RELATED MACULAR DEGENERATION AN ANALYSIS OF DATA FROM THE FI1R8T NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY , 1988 .

[63]  D Kromhout,et al.  Serum total cholesterol and long-term coronary heart disease mortality in different cultures. Twenty-five-year follow-up of the seven countries study. , 1995, JAMA.

[64]  D. Grobbee,et al.  Risk factors for mortality in users of ibopamine. , 1998, British journal of clinical pharmacology.

[65]  L. Schwartz,et al.  New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). , 2009, European journal of cancer.

[66]  J. Gofman,et al.  Blood Lipids and Human Atherosclerosis , 1950, Circulation.

[67]  L. Lesko,et al.  Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. , 2001, Annual review of pharmacology and toxicology.

[68]  J. Nilsson.  CRP--marker or maker of cardiovascular disease? , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[69]  G. Dagenais,et al.  Low-Density Lipoprotein Subfractions and the Long-Term Risk of Ischemic Heart Disease in Men: 13-Year Follow-Up Data From the Québec Cardiovascular Study , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[70]  D. Mankoff,et al.  Serial 2-[18F] fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) to monitor treatment of bone-dominant metastatic breast cancer predicts time to progression (TTP) , 2007, Breast Cancer Research and Treatment.

[71]  V. De Gruttola,et al.  An approach to the validation of markers for use in AIDS clinical trials. , 1997, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[72]  R. Collins,et al.  Blood pressure, stroke, and coronary heart disease Part 1, prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias , 1990, The Lancet.

[73]  Paul S Albert,et al.  Assessing surrogates as trial endpoints using mixed models , 2005, Statistics in medicine.

[74]  B. Schneeman.  FDA's review of scientific evidence for health claims. , 2007, The Journal of nutrition.

[75]  P. Tugwell,et al.  Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. , 2007, The Journal of rheumatology.

[76]  M D Hughes,et al.  Evaluating surrogate markers. , 1995, Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association.

[77]  MichaelTorzewski,et al.  Complement and Atherogenesis , 1999 .

[78]  A. Schatzkin.  Intermediate markers as surrogate endpoints in cancer research. , 2000, Hematology/oncology clinics of North America.

[79]  R. E. Schucker,et al.  The Impact of a Nutrition Information Program on Food Purchases , 1985 .

[80]  J. Herson.  The use of surrogate endpoints in clinical trials (an introduction to a series of four papers) , 1989 .

[81]  F. Apple,et al.  Prevention of analytical false-positive increases of cardiac troponin I on the Stratus II analyzer. , 1997, Clinical chemistry.

[82]  C Gatsonis,et al.  Validation of novel imaging methodologies for use as cancer clinical trial end-points. , 2009, European journal of cancer.

[83]  R. Olson.  Discovery of the lipoproteins, their role in fat transport and their significance as risk factors. , 1998, The Journal of nutrition.

[84]  A. Go,et al.  The prognostic value of troponin in patients with non-ST elevation acute coronary syndromes: a meta-analysis. , 2001, Journal of the American College of Cardiology.

[85]  K. Berra.  Women, coronary heart disease, and dyslipidemia: does gender alter detection, evaluation, or therapy? , 2000, The Journal of cardiovascular nursing.

[86]  R. E. Schucker,et al.  More effective nutrition label formats are not necessarily preferred. , 1992, Journal of the American Dietetic Association.

[87]  Ames,et al.  Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. , 1999, The New England journal of medicine.

[88]  B. Bloom.  Lipoproteins and atherosclerosis. , 1952, Arizona medicine.

[89]  W. Aronow.  Management of hyperlipidemia with statins in the older patient , 2006, Clinical interventions in aging.

[90]  C. Tsunehara,et al.  Gender differences in lipoprotein metabolism and dietary response: Basis in hormonal differences and implications for cardiovascular disease , 2005, Current cardiology reports.

[91]  John P. A. Ioannidis,et al.  NIAID Workshop, Memphis, Tennessee, 25-26 March 1997: Statistical issues for HIV surrogate endpoints: Point/counterpoint , 1998 .

[92]  R. Wahl,et al.  From RECIST to PERCIST: Evolving Considerations for PET Response Criteria in Solid Tumors , 2009, Journal of Nuclear Medicine.

[93]  Børge G Nordestgaard,et al.  Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial , 2009, The Lancet.

[94]  M. Burstein,et al.  [Determination of serum beta-lipoproteins after selective precipitation by heparin]. , 1958, La Presse medicale.

[95]  Daniel J Sargent,et al.  Alternate Endpoints for Screening Phase II Studies , 2009, Clinical Cancer Research.

[96]  F. Harrell,et al.  Criteria for Evaluation of Novel Markers of Cardiovascular Risk: A Scientific Statement From the American Heart Association , 2009, Circulation.

[97]  R. Baker.  Preoperative assessment of the patient with breast cancer. , 1978, The Surgical clinics of North America.

[98]  J. Broadhead,et al.  WHO consensus statement. , 1990, The British journal of psychiatry : the journal of mental science.

[99]  Geert Molenberghs,et al.  Statistical Validation of Surrogate Endpoints: Problems and Proposals , 2000 .

[100]  Samia Mora,et al.  Lipoprotein Particle Profiles by Nuclear Magnetic Resonance Compared With Standard Lipids and Apolipoproteins in Predicting Incident Cardiovascular Disease in Women , 2009, Circulation.

[101]  D. Steinberg,et al.  A critical look at the evidence for the oxidation of LDL in atherogenesis. , 1997, Atherosclerosis.

[102]  G. S. Campbell,et al.  Program on the Surgical Control of the Hyperlipidemias (POSCH): design and methodology. POSCH Group. , 1989, Journal of clinical epidemiology.

[103]  C. Weir,et al.  Statistical evaluation of biomarkers as surrogate endpoints: a literature review , 2006, Statistics in medicine.

[104]  H. Krumholz,et al.  Redefining quality--implications of recent clinical trials. , 2008, The New England journal of medicine.

[105]  R J Carroll,et al.  On meta-analytic assessment of surrogate outcomes. , 2000, Biostatistics.

[106]  Patrick A Kupelian,et al.  A model for predicting lung cancer response to therapy. , 2007, International Journal of Radiation Oncology, Biology, Physics.

[107]  J. Danesh,et al.  Low grade inflammation and coronary heart disease: prospective study and updated meta-analyses , 2000, BMJ : British Medical Journal.

[108]  K. Williams,et al.  Atherosclerosis--an inflammatory disease. , 1999, The New England journal of medicine.

[109]  S. Poole,et al.  The international standard for interleukin-6. Evaluation in an international collaborative study. , 1993, Journal of immunological methods.

[110]  D. Albanes,et al.  The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. , 1994, The New England journal of medicine.

[111]  D. Hayes.  Determination of clinical utility of tumor markers: a tumor marker utility grading system. , 1998, Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer.

[112]  A. Scanu.  Forms of human serum high density lipoprotein protein. , 1966, Journal of lipid research.

[113]  M. Laakso,et al.  Men and Women , 1901 .

[114]  B. Kramer,et al.  A perfect correlate does not a surrogate make , 2003, BMC medical research methodology.

[115]  B. Strauer,et al.  Cardiac troponin T in patients with clinically suspected myocarditis. , 1997, Journal of the American College of Cardiology.

[116]  Geert Molenberghs,et al.  Statistical challenges in the evaluation of surrogate endpoints in randomized trials. , 2002, Controlled clinical trials.

[117]  M J Daniels,et al.  Meta-analysis for the evaluation of potential surrogate markers. , 1997, Statistics in medicine.

[118]  J. Bigger.  Long-term continuous electrocardiographic recordings and electrophysiologic testing to select patients with ventricular arrhythmias for drug trials and to determine antiarrhythmic drug efficacy. , 1986, The American journal of cardiology.

[119]  D. Rader.  Molecular regulation of HDL metabolism and function: implications for novel therapies. , 2006, The Journal of clinical investigation.

[120]  L. Lind,et al.  Prevalence and pathophysiological mechanisms of elevated cardiac troponin I levels in a population-based sample of elderly subjects. , 2008, European heart journal.

[121]  M. Hughes.  Initial treatment of HIV infection: randomized trials with clinical end points are still needed. , 2006, The Journal of infectious diseases.

[122]  V. Torri,et al.  High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. , 2009, Radiology.

[123]  E. Berman,et al.  Oxygen toxicity: membrane damage by free radicals. , 1976, Investigative ophthalmology.

[124]  J. Thigpen.  Issues in Using Progression-Free Survival When Evaluating Oncology Products , 2010 .

[125]  R. Krauss,et al.  Identification of multiple subclasses of plasma low density lipoproteins in normal humans. , 1982, Journal of lipid research.

[126]  S. Dawsey,et al.  Surrogate end points in cancer research: a critique. , 1996, Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology.

[127]  G. Martinelli,et al.  Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. , 2002, Annals of oncology : official journal of the European Society for Medical Oncology.

[128]  Lan Li,et al.  C-Reactive Protein Accelerates the Progression of Atherosclerosis in Apolipoprotein E–Deficient Mice , 2004, Circulation.

[129]  B. Horne,et al.  Statin therapy, lipid levels, C-reactive protein and the survival of patients with angiographically severe coronary artery disease. , 2000, Journal of the American College of Cardiology.

[130]  M. Case,et al.  Quantifying the indirect treatment effect via surrogate markers , 2006, Statistics in medicine.

[131]  M. Pepys,et al.  C-reactive protein: binding to lipids and lipoproteins. , 1985, International review of experimental pathology.

[132]  Paul T. Williams,et al.  Smallest LDL Particles Are Most Strongly Related to Coronary Disease Progression in Men , 2002, Arteriosclerosis, thrombosis, and vascular biology.

[133]  D. DeMets,et al.  Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework , 2001, Clinical pharmacology and therapeutics.

[134]  D. Rubin,et al.  Principal Stratification in Causal Inference , 2002, Biometrics.

[135]  A. Camm,et al.  Myocardial Injury Induced by Radiofrequency and Low Energy Ablation: A Quantitative Study of CK Isoforms, CK‐MB, and Troponin‐T Concentrations , 1998, Pacing and clinical electrophysiology : PACE.

[136]  Ames,et al.  PREVENTION OF CORONARY HEART DISEASE WITH PRAVASTATIN IN MEN WITH HYPERCHOLESTEROLEMIA , 2000 .

[137]  J L Witztum,et al.  Beyond cholesterol. Modifications of low-density lipoprotein that increase its atherogenicity. , 1989, The New England journal of medicine.

[138]  Stuart G Baker,et al.  A simple meta-analytic approach for using a binary surrogate endpoint to predict the effect of intervention on true endpoint. , 2006, Biostatistics.

[139]  Bradley J Erickson,et al.  Validation of neuroradiologic response assessment in gliomas: measurement by RECIST, two-dimensional, computer-assisted tumor area, and computer-assisted tumor volume methods. , 2006, Neuro-oncology.

[140]  G. Omenn,et al.  Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. , 1996, The New England journal of medicine.

[141]  K. S. Webb,et al.  Urinary fibronectin: potential as a biomarker in prostatic cancer. , 1980, Investigative urology.

[142]  P. Libby,et al.  Vascular Biomarkers and Surrogates in Cardiovascular Disease , 2006, Circulation.

[143]  M. Hlatky.  Expanding the orbit of primary prevention--moving beyond JUPITER. , 2008, The New England journal of medicine.

[144]  W eekly,et al.  U.S. Department of Health, Education, and Welfare , 1965, Anesthesia progress.

[145]  J. Drazen,et al.  Trial registration report card. , 2005, The New England journal of medicine.

[146]  Paul Schoenhagen,et al.  Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. , 2003, JAMA.

[147]  Elementary Medical Statistics. , 1954 .

[148]  George A Mensah,et al.  An overview of cardiovascular disease burden in the United States. , 2007, Health affairs.

[149]  B. Graubard,et al.  Statistical validation of intermediate endpoints for chronic diseases. , 1992, Statistics in medicine.

[150]  G. Guyatt,et al.  Users' guides to the medical literature. , 1993, JAMA.

[151]  U. Menon.  Ovarian cancer screening , 2002, Canadian Medical Association Journal.

[152]  Mette Jensen,et al.  Tumor volume in subcutaneous mouse xenografts measured by microCT is more accurate and reproducible than determined by 18F-FDG-microPET or external caliper , 2008, BMC Medical Imaging.

[153]  J. Whicher.  BCR/IFCC reference material for plasma proteins (CRM 470). Community Bureau of Reference. International Federation of Clinical Chemistry. , 1998, Clinical biochemistry.

[154]  Riccardo Lencioni,et al.  Design and endpoints of clinical trials in hepatocellular carcinoma. , 2008, Journal of the National Cancer Institute.

[155]  Joshua M Sharfstein,et al.  The FDA as a public health agency. , 2009, The New England journal of medicine.

[156]  C. Lathia.  Biomarkers and Surrogate Endpoints: How and When might They Impact Drug Development? , 2002, Disease markers.

[157]  I. Carrió.  EANM-ESR white paper on multimodality imaging , 2008, European Journal of Nuclear Medicine and Molecular Imaging.

[158]  Michael J Pencina,et al.  LDL Particle Number and Risk of Future Cardiovascular Disease in the Framingham Offspring Study - Implications for LDL Management. , 2007, Journal of clinical lipidology.

[159]  J. D. de Lemos,et al.  Biomarkers and cardiovascular disease: determining causality and quantifying contribution to risk assessment. , 2009, Journal of the American Medical Association (JAMA).

[160]  Mary Anne Raymond,et al.  Consumer Perceptions of Health Claims in Advertisements and on Food Labels , 1997 .

[161]  D. Morrow,et al.  Troponins in acute coronary syndromes. , 2004, Progress in cardiovascular diseases.

[162]  P. Wood.  Where are we now with radiographic assessment of rheumatoid arthritis? , 1983, British journal of rheumatology.

[163]  D. Sargent,et al.  Surrogate endpoint validation: statistical elegance versus clinical relevance , 2008, Statistical methods in medical research.

[164]  Harold L. Moses,et al.  Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment , 2007 .

[165]  Yi Ni Chen,et al.  Cardiac Troponin I: A Marker for Post-Burn Cardiac Injury , 2000, Annals of clinical biochemistry.

[166]  Steven V. Ley,et al.  Targeting C-reactive protein for the treatment of cardiovascular disease , 2006, Nature.

[167]  P. Gaffney,et al.  A Collaborative Study to Establish the 2nd International Standard for Fibrinogen, Plasma , 2000, Thrombosis and Haemostasis.

[168]  A. Jaffe,et al.  The clinical need for high-sensitivity cardiac troponin assays for acute coronary syndromes and the role for serial testing. , 2008, American heart journal.

[169]  Vance W Berger,et al.  Does the Prentice criterion validate surrogate endpoints? , 2004, Statistics in medicine.

[170]  K C Cain,et al.  Total serum cholesterol levels and mortality risk as a function of age. A report based on the Framingham data. , 1993, Archives of internal medicine.

[171]  B. V. Van Beers,et al.  Biomarkers in abdominal imaging , 2009, Abdominal Imaging.

[172]  P. Rolan.  The contribution of clinical pharmacology surrogates and models to drug development--a critical appraisal. , 2003, British journal of clinical pharmacology.

[173]  H. Stich,et al.  Use of intermediate endpoints in quantitating the response of precancerous lesions to chemopreventive agents. , 1987, Canadian journal of physiology and pharmacology.

[174]  J. Gofman,et al.  The serum lipoprotein transport system in health, metabolic disorders, atherosclerosis and coronary heart disease. , 2007, Journal of clinical lipidology.

[175]  U. Singh,et al.  C-Reactive Protein Decreases Tissue Plasminogen Activator Activity in Human Aortic Endothelial Cells: Evidence that C-Reactive Protein Is a Procoagulant , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[176]  R. Lotan,et al.  Biomarkers as intermediate end points in chemoprevention trials. , 1990, Journal of the National Cancer Institute.

[177]  R. Knopp,et al.  Comprehensive lipid management versus aggressive low-density lipoprotein lowering to reduce cardiovascular risk. , 2008, The American journal of cardiology.

[178]  Roman K. Thomas,et al.  Early Detection of Erlotinib Treatment Response in NSCLC by 3′-Deoxy-3′-[18F]-Fluoro-L-Thymidine ([18F]FLT) Positron Emission Tomography (PET) , 2008, PloS one.

[179]  G. Molenberghs,et al.  The validation of surrogate endpoints in meta-analyses of randomized experiments. , 2000, Biostatistics.

[180]  Rodney A Hayward,et al.  Narrative Review: Lack of Evidence for Recommended Low-Density Lipoprotein Treatment Targets: A Solvable Problem , 2006, Annals of Internal Medicine.

[181]  Drummond Rennie,et al.  Trial registration: a great idea switches from ignored to irresistible. , 2004, JAMA.

[182]  N. Cook.  Statistical evaluation of prognostic versus diagnostic models: beyond the ROC curve. , 2008, Clinical chemistry.

[183]  B. Nordestgaard.  Does elevated C-reactive protein cause human atherothrombosis? Novel insights from genetics, intervention trials, and elsewhere , 2009, Current opinion in lipidology.

[184]  E. Gehan,et al.  Will there be resistance to the RECIST (Response Evaluation Criteria in Solid Tumors)? , 2000, Journal of the National Cancer Institute.

[185]  E. Sasse,et al.  Variability in cholesterol measurements: comparison of calculated and direct LDL cholesterol determinations. , 1996, Clinical chemistry.

[186]  John A. Wagner,et al.  Overview of Biomarkers and Surrogate Endpoints in Drug Development , 2002, Disease markers.

[187]  A simple method for analyzing data from a randomized trial with a missing binary outcome , 2003, BMC medical research methodology.

[188]  A. Aromaa,et al.  Serum antioxidants and risk of rheumatoid arthritis. , 1994, Annals of the rheumatic diseases.

[189]  Larry Rubinstein,et al.  Phase 0 clinical trial of the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[190]  S. Marcovina,et al.  Apolipoprotein A1 and B. , 2006, Clinics in laboratory medicine.

[191]  David M. Parenti,et al.  Phase I/II trial of thymosin fraction 5 and thymosin alpha one in HTLV-III seropositive subjects. , 1986, Journal of biological response modifiers.

[192]  Nicholas C. Ide,et al.  Issues in the registration of clinical trials. , 2007, JAMA.

[193]  O. Bouché,et al.  Imaging techniques to evaluate the response to treatment in oncology: current standards and perspectives. , 2009, Critical reviews in oncology/hematology.

[194]  A. Dyer,et al.  Major risk factors as antecedents of fatal and nonfatal coronary heart disease events. , 2003, JAMA.

[195]  P. Kincade,et al.  Excerpts from Unlocking Our Future: Toward a New National Science Policy , 1999 .

[196]  C. Bauters,et al.  [Pathophysiology of coronary artery disease]. , 2008, La Revue du praticien.

[197]  D. Reboussin,et al.  Effects of estrogen replacement on the progression of coronary-artery atherosclerosis. , 2000, The New England journal of medicine.

[198]  M. Pepys,et al.  The first international standard for serum amyloid A protein (SAA). Evaluation in an international collaborative study. , 1998, Journal of immunological methods.

[199]  A. Wu,et al.  Quality Specifications for Cardiac Troponin Assays , 2001, Clinical chemistry and laboratory medicine.

[200]  Nader Rifai,et al.  Preanalytic and analytic sources of variations in C-reactive protein measurement: implications for cardiovascular disease risk assessment. , 2003, Clinical chemistry.

[201]  A. Tall,et al.  Plasma cholesteryl ester transfer protein. , 1993, Journal of lipid research.

[202]  K. O. Pedersen.  On a low-density lipoprotein appearing in normal human plasma. , 1947, The Journal of physical and colloid chemistry.

[203]  A. Sniderman.  How, when, and why to use apolipoprotein B in clinical practice. , 2002, The American journal of cardiology.

[204]  Lisa A Bero,et al.  Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. , 2009, JAMA.

[205]  E. Eisenhauer,et al.  RECIST revisited: a review of validation studies on tumour assessment. , 2006, European journal of cancer.

[206]  S. Fanti,et al.  18FDG-PET Evaluation Correlates Better than CT with Pathological Response in a Metastatic Colon Cancer Patient Treated with Bevacizumab-Based Therapy , 2007, Tumori.

[207]  Young Suk Park,et al.  Measuring response in solid tumors: comparison of RECIST and WHO response criteria. , 2003, Japanese journal of clinical oncology.

[208]  J. Collet,et al.  Surrogate endpoints: A basis for a rational approach , 2006, European Journal of Clinical Pharmacology.

[209]  E. Yetley,et al.  Focus group sessions on formats of nutrition labels. , 1992, Journal of the American Dietetic Association.

[210]  W. Roberts.  CDC/AHA Workshop on Markers of Inflammation and Cardiovascular Disease: Application to Clinical and Public Health Practice Laboratory Tests Available to Assess Inflammation— Performance and Standardization A Background Paper , 2004, Circulation.

[211]  C. Cannon.  Balancing the benefits of statins versus a new risk—diabetes , 2010, The Lancet.

[212]  Sridevi Devaraj,et al.  Apolipoprotein B and cardiovascular disease risk: position statement from the AACC Lipoproteins and Vascular Diseases Division Working Group on Best Practices. , 2009, Clinical chemistry.

[213]  Y. Itai,et al.  Assessment of Cervical Cancer Radioresponse by Serum Squamous Cell Carcinoma Antigen and Magnetic Resonance Imaging , 2002, Obstetrics and gynecology.

[214]  T. Fleming.  Surrogate end points in cardiovascular disease trials. , 2000, American heart journal.

[215]  J. Giddings,et al.  C-Reactive Protein–Induced In Vitro Endothelial Cell Activation Is an Artefact Caused by Azide and Lipopolysaccharide , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[216]  K. Lee,et al.  Serum cholesterol in patients undergoing cardiac catheterization for suspected coronary artery disease: diagnostic and prognostic implications. , 1992, Annals of epidemiology.

[217]  D. Rubin.  Direct and Indirect Causal Effects via Potential Outcomes * , 2004 .

[218]  J. Hewitt,et al.  The role of lipids and lipoproteins in atherosclerosis. , 1950, Science.

[219]  D. Hoefner.  The cholesterol controversy continues. , 2008, MLO: medical laboratory observer.

[220]  K. Lee,et al.  Perspectives on large-scale cardiovascular clinical trials for the new millennium. The Virtual Coordinating Center for Global Collaborative Cardiovascular Research (VIGOUR) Group. , 1997, Circulation.

[221]  J. Frohlich,et al.  Can measurement of serum apolipoprotein B replace the lipid profile monitoring of patients with lipoprotein disorders? , 2002, Clinical chemistry.

[222]  W. Castelli.  Lipids, risk factors and ischaemic heart disease. , 1996, Atherosclerosis.

[223]  James T. Willerson,et al.  Direct Proinflammatory Effect of C-Reactive Protein on Human Endothelial Cells , 2000, Circulation.

[224]  R. Ross.  The pathogenesis of atherosclerosis: a perspective for the 1990s , 1993, Nature.

[225]  Y. Watanabe,et al.  The effect of selective breeding on the development of coronary atherosclerosis in WHHL rabbits. An animal model for familial hypercholesterolemia. , 1985, Atherosclerosis.

[226]  N. Nagelkerke,et al.  Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials. , 1994, Statistics in medicine.

[227]  A. Bendich.  Dietary reference intakes for vitamin C, vitamin E, selenium, and carotenoids institute of medicine washington, DC: National Academy Press, 2000 ISBN: 0-309-06935-1 , 2001 .

[228]  Michael F. Oliver,et al.  Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes. The MIRACL study. , 2001, Indian heart journal.

[229]  B. Psaty,et al.  Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. , 2004, JAMA.

[230]  W. Colburn,et al.  Surrogate Biochemical Markers: Precise Measurement for Strategic Drug and Biologics Development , 1995, Journal of clinical pharmacology.

[231]  R M Whitlock,et al.  Relation between troponin T concentration and mortality in patients presenting with an acute stroke: observational study , 2000, BMJ : British Medical Journal.

[232]  Michael L Maitland,et al.  Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. , 2007, Journal of the National Cancer Institute.

[233]  Nutrition labeling and public health: survey of American-Institute of Nutrition members, food industry, and consumers. , 1982, The American journal of clinical nutrition.

[234]  D. Goldstein,et al.  Gastrointestinal Stromal Tumours: Correlation of 18F-FDG Gamma Camera-Based Coincidence Positron Emission Tomography with CT for the Assessment of Treatment Response – An AGITG Study , 2005, Oncology.

[235]  P. Hopkins,et al.  A survey of 246 suggested coronary risk factors. , 1981, Atherosclerosis.

[236]  Nancy R Cook,et al.  The Effect of Including C-Reactive Protein in Cardiovascular Risk Prediction Models for Women , 2006, Annals of Internal Medicine.

[237]  A. Jaffe.  Elevations in cardiac troponin measurements: False false-positives , 2007, Cardiovascular Toxicology.

[238]  M. Meredith,et al.  A method to assess the proportion of treatment effect explained by a surrogate endpoint , 2001, Statistics in medicine.

[239]  J. Mrochek,et al.  Serum protein-bound carbohydrates for following the course of disease in patients with metastatic breast carcinoma. , 1978, Journal of the National Cancer Institute.

[240]  J. Neaton,et al.  Diabetes, Other Risk Factors, and 12-Yr Cardiovascular Mortality for Men Screened in the Multiple Risk Factor Intervention Trial , 1993, Diabetes Care.

[241]  Laura A. Levit,et al.  Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: National Academies Press , 2009 .

[242]  N. Childs,et al.  Consumer Perceptions of Graded, Graphic and Text Label Presentations for Qualified Health Claims , 2008, Critical reviews in food science and nutrition.

[243]  José A Fernández,et al.  High-density lipoprotein enhancement of anticoagulant activities of plasma protein S and activated protein C. , 1999, The Journal of clinical investigation.

[244]  Christine L Taylor,et al.  How the nutrition food label was developed, Part 2: the purpose and promise of nutrition claims. , 2008, Journal of the American Dietetic Association.

[245]  A. Gotto,et al.  Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. , 1998, JAMA.

[246]  Tomasz Burzykowski,et al.  Surrogate endpoints: wishful thinking or reality? , 2008, Statistical methods in medical research.

[247]  A. Wood.  Playing "kick the FDA"--risk-free to players but hazardous to public health. , 2008, The New England journal of medicine.

[248]  Thomas R Fleming,et al.  Surrogate endpoints and FDA's accelerated approval process. , 2005, Health affairs.

[249]  Nader Rifai,et al.  Methods for measurement of LDL-cholesterol: a critical assessment of direct measurement by homogeneous assays versus calculation. , 2002, Clinical chemistry.

[250]  E. Yeh,et al.  CRP and the risk of atherosclerotic events , 2009, Seminars in Immunopathology.

[251]  E. Braunwald,et al.  A classification of unstable angina revisited. , 2000, Circulation.

[252]  M. Virkkunen.  Lipid Research Clinics Coronary Primary Prevention Trial results. , 1985, JAMA.

[253]  C. W. van den Berg,et al.  Letter in response to Bisoendial et al: "activation of inflammation and coagulation after infusion of C-reactive protein in humans". , 2005, Circulation research.

[254]  J. Cohn,et al.  Prognostic Value of Very Low Plasma Concentrations of Troponin T in Patients With Stable Chronic Heart Failure , 2007, Circulation.

[255]  M. Gail,et al.  On the use of laboratory markers as surrogates for clinical endpoints in the evaluation of treatment for HIV infection. , 1990, Journal of acquired immune deficiency syndromes.

[256]  Giovanni Martinelli,et al.  Prevention of High-Dose Chemotherapy-Induced Cardiotoxicity in High-Risk Patients by Angiotensin-Converting Enzyme Inhibition , 2006, Circulation.

[257]  Peter Libby,et al.  Inflammation in Atherosclerosis : From Vascular Biology to Biomarker Discovery and Risk Prediction , 2007 .

[258]  M. Pepys.  CRP or not CRP? That is the question. , 2005, Arteriosclerosis, thrombosis, and vascular biology.

[259]  Alan Jackson,et al.  Using Bayesian tissue classification to improve the accuracy of vestibular schwannoma volume and growth measurement. , 2002, AJNR. American journal of neuroradiology.

[260]  Standardization of high-sensitivity immunoassays for measurement of C-reactive protein; II: Two approaches for assessing commutability of a reference material. , 2009, Clinical chemistry.

[261]  N. Rifai,et al.  Standardization of immunoassays for measurement of high-sensitivity C-reactive protein. Phase I: evaluation of secondary reference materials. , 2003, Clinical chemistry.

[262]  R. Gonzalez,et al.  MRI in treatment of adult gliomas. , 2005, The Lancet. Oncology.

[263]  Wolfgang A Weber,et al.  Assessing Tumor Response to Therapy , 2009, Journal of Nuclear Medicine.

[264]  C. Vassanelli,et al.  [Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban]. , 2001, Italian heart journal. Supplement : official journal of the Italian Federation of Cardiology.

[265]  J. Shepherd,et al.  Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomized controlled trial , 2003 .

[266]  Marissa N Lassere,et al.  The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints , 2008, Statistical methods in medical research.

[267]  P. Libby,et al.  Novel inflammatory markers of coronary risk: theory versus practice. , 1999, Circulation.

[268]  C. Levy,et al.  Influence of renal insufficiency on levels of serum ribonuclease in patients with multiple myeloma. , 1977, Journal of the National Cancer Institute.

[269]  D. Nitti,et al.  Correlation between Magnetic Resonance Imaging and Histopathological Tumor Response after Neoadjuvant Chemotherapy in Breast Cancer , 2008, Tumori.

[270]  Yan Wang,et al.  Surrogate markers and joint models for longitudinal and survival data. , 2002, Controlled clinical trials.

[271]  J. Manson,et al.  Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. , 1999, Journal of the National Cancer Institute.

[272]  G. Cooper,et al.  A brief history of lipid and lipoprotein measurements and their contribution to clinical chemistry. , 2006, Clinica chimica acta; international journal of clinical chemistry.

[273]  D. DeMets,et al.  Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. , 2001, Controlled clinical trials.

[274]  L. Smeeth,et al.  Critical appraisal of CRP measurement for the prediction of coronary heart disease events: new data and systematic review of 31 prospective cohorts. , 2009, International journal of epidemiology.

[275]  G. Steers,et al.  Initial assessment of a model relating intratumoral genetic heterogeneity to radiological morphology. , 2010, The British journal of radiology.

[276]  L. Wood,et al.  Oxidative Stress in Cystic Fibrosis: Dietary and Metabolic Factors , 2001, Journal of the American College of Nutrition.

[277]  L. Correia,et al.  HDL-cholesterol level provides additional prognosis in acute coronary syndromes. , 2009, International journal of cardiology.

[278]  K. Herholz,et al.  Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. , 1999, European journal of cancer.

[279]  J. DiGiovanni,et al.  Evidence for autocrine/paracrine growth stimulation by transforming growth factor‐α during the process of skin tumor promotion , 1991, Molecular carcinogenesis.

[280]  J. Farmer.  Pleiotropic effects of statins , 2000, Current atherosclerosis reports.

[281]  M J Ratain,et al.  Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. , 1993, Journal of the National Cancer Institute.

[282]  K. Yano,et al.  Cholesterol and all-cause mortality in elderly people from the Honolulu Heart Program: a cohort study , 2001, The Lancet.

[283]  J. Spence,et al.  Measurement of atherosclerosis: development of an atherosclerosis severity index. , 1989, Clinical and experimental hypertension. Part A, Theory and practice.

[284]  Sheila Prindiville,et al.  Effect of Raloxifene on Mammographic Density and Breast Magnetic Resonance Imaging in Premenopausal Women at Increased Risk for Breast Cancer , 2008, Cancer Epidemiology Biomarkers & Prevention.

[285]  E. Steyerberg,et al.  Rosuvastatin in patients with elevated C-reactive protein. , 2009, The New England journal of medicine.

[286]  Stephen A. Williams,et al.  The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development , 2009, Clinical pharmacology and therapeutics.

[287]  Eric J Topol,et al.  Prevalence of conventional risk factors in patients with coronary heart disease. , 2003, JAMA.

[288]  G. Molenberghs,et al.  Criteria for the validation of surrogate endpoints in randomized experiments. , 1998, Biometrics.

[289]  M. Pfeffer,et al.  Inflammation, pravastatin, and the risk of coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events (CARE) Investigators. , 1998, Circulation.

[290]  E. Rubin,et al.  Severe hypercholesterolemia and atherosclerosis in apolipoprotein E-deficient mice created by homologous recombination in ES cells , 1992, Cell.

[291]  Michael Bader,et al.  Early prediction of response to chemotherapy in metastatic breast cancer using sequential 18F-FDG PET. , 2005, Journal of nuclear medicine : official publication, Society of Nuclear Medicine.

[292]  M. Lopes-Virella,et al.  The role of immune and inflammatory processes in the development of macrovascular disease in diabetes. , 2003, Frontiers in bioscience : a journal and virtual library.

[293]  Commentary: Where and how could biomarkers be used in 2016 , 2006, The AAPS Journal.

[294]  G. Molenberghs,et al.  Surrogate end points: hopes and perils , 2008, Expert review of pharmacoeconomics & outcomes research.

[295]  R. Havel,et al.  The distribution and chemical composition of ultracentrifugally separated lipoproteins in human serum. , 1955, The Journal of clinical investigation.

[296]  C. Spies,et al.  Serum cardiac troponin T as a prognostic marker in early sepsis. , 1998, Chest.

[297]  P. Williams,et al.  Consumer understanding and use of health claims for foods. , 2005, Nutrition reviews.

[298]  D Amakye,et al.  A Prototypical Process for Creating Evidentiary Standards for Biomarkers and Diagnostics , 2008, Clinical pharmacology and therapeutics.

[299]  Yuting Zhang,et al.  Axillary Lymph Node Status, But Not Tumor Size, Predicts Locoregional Recurrence and Overall Survival After Mastectomy for Breast Cancer , 2003, Annals of surgery.

[300]  C. Sabin,et al.  Transgenic human C-reactive protein is not proatherogenic in apolipoprotein E-deficient mice. , 2005, Proceedings of the National Academy of Sciences of the United States of America.

[301]  Brian E. Roe,et al.  The Impact of Health Claims on Consumer Search and Product Evaluation Outcomes: Results from FDA Experimental Data , 1999 .

[302]  T. Wong,et al.  Dietary antioxidants and primary prevention of age related macular degeneration: systematic review and meta-analysis , 2007, BMJ : British Medical Journal.

[303]  P Flandre,et al.  Estimating the proportion of treatment effect explained by a surrogate marker. , 1999, Statistics in Medicine.

[304]  D. Bluemke,et al.  Magnetic resonance imaging of the liver: assessing response to treatment. , 2002, Topics in magnetic resonance imaging : TMRI.

[305]  M. Caulfield,et al.  Effects of torcetrapib in patients at high risk for coronary events. , 2007, The New England journal of medicine.

[306]  Eric Boerwinkle,et al.  An assessment of incremental coronary risk prediction using C-reactive protein and other novel risk markers: the atherosclerosis risk in communities study. , 2006, Archives of internal medicine.

[307]  S. Feasson,et al.  MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals : a randomised placebo-controlled trial. , 2008 .

[308]  C. Meyer,et al.  Sodium and proton diffusion MRI as biomarkers for early therapeutic response in subcutaneous tumors. , 2006, Magnetic resonance imaging.

[309]  F. P. Anderson,et al.  Performance of four homogeneous direct methods for LDL-cholesterol. , 2002, Clinical chemistry.

[310]  A. Jaffe,et al.  It's time for a change to a troponin standard. , 2000, Circulation.

[311]  M. Srinivasan,et al.  The Antioxidants in Prevention of Cataracts Study: effects of antioxidant supplements on cataract progression in South India , 2006, British Journal of Ophthalmology.

[312]  U. Sharma,et al.  Longitudinal study of the assessment by MRI and diffusion‐weighted imaging of tumor response in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy , 2009, NMR in biomedicine.

[313]  Draft Guidance.  Contains Nonbinding Recommendations Guidance for Industry ! Evidence-Based Review System for the Scientific Evaluation of Health Claims , 2007 .

[314]  Haesun Choi,et al.  Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[315]  D. Lloyd‐Jones,et al.  C-reactive protein in the prediction of cardiovascular events. , 2003, The New England journal of medicine.

[316]  J. Wagner,et al.  Biomarkers and Surrogate End Points for Fit‐for‐Purpose Development and Regulatory Evaluation of New Drugs , 2007, Clinical pharmacology and therapeutics.

[317]  C. McCulloch,et al.  Latent Class Models for Joint Analysis of Longitudinal Biomarker and Event Process Data , 2002 .

[318]  P. Wilson,et al.  Incidence of coronary heart disease and lipoprotein cholesterol levels. The Framingham Study. , 1986, JAMA.

[319]  I. Kaplan,et al.  When is a heterophile antibody not a heterophile antibody? When it is an antibody against a specific immunogen. , 1999, Clinical chemistry.

[320]  Richard C. Pais,et al.  Comparison of treatment response classifications between unidimensional, bidimensional, and volumetric measurements of metastatic lung lesions on chest computed tomography. , 2004, Academic radiology.

[321]  A. Motulsky,et al.  Hyperlipidemia in coronary heart disease. I. Lipid levels in 500 survivors of myocardial infarction. , 1973, The Journal of clinical investigation.

[322]  Ratapol P. Teratanavat,et al.  Dissecting Qualified Health Claims: Evidence From Experimental Studies , 2008, Critical reviews in food science and nutrition.

[323]  M. Buyse,et al.  Simulation studies of surrogate endpoint validation using single trial and multitrial statistical approaches. , 2007, The Journal of rheumatology.

[324]  The Lipid Research Clinics Coronary Primary Prevention Trial results. II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. , 1984, JAMA.

[325]  J. Stamler.  Clofibrate and niacin in coronary heart disease. , 1975, JAMA.

[326]  J. Stamler,et al.  Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. , 1986, Journal of the American College of Cardiology.

[327]  R. Blumenthal,et al.  Prevalence of low low-density lipoprotein cholesterol with elevated high sensitivity C-reactive protein in the U.S.: implications of the JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) study. , 2009, Journal of the American College of Cardiology.

[328]  A. von Eckardstein,et al.  HDL and arteriosclerosis: beyond reverse cholesterol transport. , 2002, Atherosclerosis.

[329]  Rabiya S Tuma,et al.  Sometimes size doesn't matter: reevaluating RECIST and tumor response rate endpoints. , 2006, Journal of the National Cancer Institute.

[330]  Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. , 2001, The New England journal of medicine.

[331]  Sidney C. Smith,et al.  MARKERS OF INFLAMMATION AND CARDIOVASCULAR DISEASE: APPLICATION TO CLINICAL AND PUBLIC HEALTH PRACTICE: A STATEMENT FOR HEALTHCARE PROFESSIONALS FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND THE AMERICAN HEART ASSOCIATION , 2003 .

[332]  Haesun Choi,et al.  We should desist using RECIST, at least in GIST. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[333]  S. Dawsey,et al.  Validation of intermediate end points in cancer research. , 1990, Journal of the National Cancer Institute.

[334]  L. Tenkanen,et al.  Joint Effects of Serum Triglyceride and LDL Cholesterol and HDL Cholesterol Concentrations on Coronary Heart Disease Risk in the Helsinki Heart Study , 1992 .

[335]  R. Kerbel.  Antiangiogenic Therapy: A Universal Chemosensitization Strategy for Cancer? , 2006, Science.

[336]  A. D. Van den Abbeele,et al.  Phase II trial of lapatinib for brain metastases in patients with human epidermal growth factor receptor 2-positive breast cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[337]  Giovanni Martinelli,et al.  Minor increases in plasma troponin I predict decreased left ventricular ejection fraction after high-dose chemotherapy. , 2003, Clinical chemistry.

[338]  M. Bazzocchi,et al.  Tumor measurements on computed tomographic images of non-small cell lung cancer were similar among cancer professionals from different specialties. , 2004, Journal of clinical epidemiology.

[339]  R. Krauss,et al.  Metabolic origins and clinical significance of LDL heterogeneity DOI 10.1194/jlr.R200004-JLR200 , 2002, Journal of Lipid Research.

[340]  Left ventricular dysfunction predicted by early troponin I release after high-dose chemotherapy. , 2000, Journal of the American College of Cardiology.

[341]  S. Ghosh,et al.  Utility of Adiponectin as a Biomarker Predictive of Glycemic Efficacy Is Demonstrated by Collaborative Pooling of Data From Clinical Trials Conducted by Multiple Sponsors , 2009, Clinical pharmacology and therapeutics.

[342]  A. Lichtenstein.  Cancer as a Programmed Death of an Organism , 2005, Biochemistry (Moscow).

[343]  R. Hegele,et al.  The failure of torcetrapib: what have we learned? , 2008, British journal of pharmacology.

[344]  D. Sargent,et al.  Meta-analysis for the evaluation of surrogate endpoints in cancer clinical trials , 2009, International Journal of Clinical Oncology.

[345]  J. Ruskin,et al.  The cardiac arrhythmia suppression trial (CAST). , 1989, The New England journal of medicine.

[346]  N. Cook.  Use and Misuse of the Receiver Operating Characteristic Curve in Risk Prediction , 2007, Circulation.

[347]  J. Manson,et al.  A randomized factorial trial of vitamins C and E and beta carotene in the secondary prevention of cardiovascular events in women: results from the Women's Antioxidant Cardiovascular Study. , 2007, Archives of internal medicine.

[348]  J. Morrison,et al.  Cardiac troponin I in pre‐eclampsia and gestational hypertension , 2000, BJOG : an international journal of obstetrics and gynaecology.

[349]  Fred S Apple,et al.  A new season for cardiac troponin assays: it's time to keep a scorecard. , 2009, Clinical chemistry.

[350]  Nicholas J Wareham,et al.  Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: the EPIC-Norfolk Prospective Population Study. , 2007, Journal of the American College of Cardiology.

[351]  R. Hegele,et al.  Is raising HDL a futile strategy for atheroprotection? , 2008, Nature Reviews Drug Discovery.

[352]  L. Hirsch,et al.  Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors , 2008, Current medical research and opinion.

[353]  W. Kannel,et al.  Factors of risk in the development of coronary heart disease--six year follow-up experience. The Framingham Study. , 1961, Annals of internal medicine.

[354]  N. Sattar,et al.  Novel antecedent plasma biomarkers of cardiovascular disease: improved evaluation methods and comparator benchmarks raise the bar , 2008, Current opinion in lipidology.

[355]  M. Hughes.  Evaluating surrogate endpoints. , 2002, Controlled clinical trials.

[356]  S L Zeger,et al.  The Evaluation of Multiple Surrogate Endpoints , 2001, Biometrics.

[357]  J O Barentsz,et al.  Beyond RECIST: molecular and functional imaging techniques for evaluation of response to targeted therapy. , 2009, Cancer treatment reviews.

[358]  P. Ridker,et al.  Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. , 1997, The New England journal of medicine.

[359]  A. Khera,et al.  Prevalence and Determinants of Troponin T Elevation in the General Population , 2006, Circulation.

[360]  M. Lopes-Virella,et al.  Atherogenesis and the humoral immune response to modified lipoproteins. , 2008, Atherosclerosis.

[361]  A. Tall,et al.  Dietary cholesterol increases transcription of the human cholesteryl ester transfer protein gene in transgenic mice. Dependence on natural flanking sequences. , 1992, The Journal of clinical investigation.

[362]  Filippo Cademartiri,et al.  Imaging for oncologic staging and follow-up: review of current methods and novel approaches. , 2008, Acta bio-medica : Atenei Parmensis.

[363]  Shahrul Mt-Isa,et al.  Genetic Loci associated with C-reactive protein levels and risk of coronary heart disease. , 2009, JAMA.

[364]  Jeremy M G Taylor,et al.  A Measure of the Proportion of Treatment Effect Explained by a Surrogate Marker , 2002, Biometrics.

[365]  D. Levy,et al.  Multiple biomarkers for the prediction of first major cardiovascular events and death. , 2006, The New England journal of medicine.

[366]  Haesun Choi.  Critical issues in response evaluation on computed tomography: Lessons from the gastrointestinal stromal tumor model , 2005, Current oncology reports.

[367]  David B. Lee.  Foundation for the National Institutes of Health: Facilitating the Development and Qualification of Alzheimer's Disease Biomarkers Through Novel Public-Private Partnerships , 2009, Alzheimer's & Dementia.

[368]  S. Ellenberg,et al.  Surrogate endpoints in clinical trials: cancer. , 1989, Statistics in medicine.

[369]  A. Sevinç,et al.  ‘Please, Desist RECIST Criteria in GIST, At Least in Me’ , 2008, Oncology Research and Treatment.

[370]  C. Begg,et al.  On the use of surrogate end points in randomized trials , 2000 .

[371]  H. Bouzourène,et al.  Pharyngeal pituitary non-functioning adenoma with normal intra-sellar gland: massive tumor shrinkage on octreotide therapy. , 2003, European journal of endocrinology.

[372]  M. Field,et al.  Safe medical devices for children , 2006 .

[373]  A. Tall,et al.  Increased high-density lipoprotein levels caused by a common cholesteryl-ester transfer protein gene mutation. , 1990, The New England journal of medicine.

[374]  Fred S Apple,et al.  National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. , 2007, Circulation.

[375]  G. Molenberghs,et al.  Surrogate Marker Evaluation from an Information Theory Perspective , 2007, Biometrics.

[376]  Thomas Weber,et al.  Intensive versus moderate lipid lowering with statins after acute coronary syndromes. , 2004, The New England journal of medicine.

[377]  T. Fleming,et al.  Perspective: validating surrogate markers--are we being naive? , 1997, The Journal of infectious diseases.

[378]  R. Krauss,et al.  Dense low density lipoproteins and coronary artery disease. , 1995, The American journal of cardiology.

[379]  V. Fuster,et al.  The use of high-sensitivity assays for C-reactive protein in clinical practice , 2008, Nature Clinical Practice Cardiovascular Medicine.

[380]  R. Gillies,et al.  Imaging hemodynamics , 2008, Cancer and Metastasis Reviews.

[381]  E. Wardelmann,et al.  [Surgical considerations for gastrointestinal stroma tumor]. , 2006, Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen.

[382]  R Peto,et al.  Association of fibrinogen, C-reactive protein, albumin, or leukocyte count with coronary heart disease: meta-analyses of prospective studies. , 1998, JAMA.

[383]  J. Manson,et al.  Beta carotene supplementation and age-related maculopathy in a randomized trial of US physicians. , 2007, Archives of ophthalmology.

[384]  R. Meuli,et al.  Perfusion and diffusion MRI of glioblastoma progression in a four-year prospective temozolomide clinical trial. , 2006, International Journal of Radiation Oncology, Biology, Physics.

[385]  A. J. Bauman,et al.  A search for porphyrin biomarkers in nonesuch shale and extraterrestrial samples , 2007, Space life sciences.

[386]  M Aickin,et al.  If there is gold in the labeling index hills, are we digging in the right place? , 1994, Journal of cellular biochemistry. Supplement.

[387]  J. Wagner.  Strategic approach to fit-for-purpose biomarkers in drug development. , 2008, Annual review of pharmacology and toxicology.

[388]  P. Trumbo,et al.  Surrogate endpoints and emerging surrogate endpoints for risk reduction of cardiovascular disease. , 2008, Nutrition reviews.

[389]  Raymond E. Schucker,et al.  Performance Characteristics of Seven Nutrition Label Formats , 1996 .

[390]  Drummond Rennie,et al.  Postmarketing surveillance--lack of vigilance, lack of trust. , 2004, JAMA.

[391]  Vilmundur Gudnason,et al.  C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. , 2004, The New England journal of medicine.

[392]  G. Molenberghs,et al.  A perspective on surrogate endpoints in controlled clinical trials , 2004, Statistical methods in medical research.

[393]  G. Reboldi,et al.  Prognostic value of lipoprotein fractions in essential hypertension , 2004, Blood pressure.

[394]  S. Robins.  Targeting low high-density lipoprotein cholesterol for therapy: lessons from the Veterans Affairs High-density Lipoprotein Intervention Trial. , 2001, The American journal of cardiology.

[395]  I. Kamel,et al.  Assessment of metastatic breast cancer response to chemoembolization with contrast agent enhanced and diffusion-weighted MR imaging. , 2007, Journal of vascular and interventional radiology : JVIR.

[396]  L S Freedman,et al.  Sample size for studying intermediate endpoints within intervention trails or observational studies. , 1992, American journal of epidemiology.

[397]  F. Sacks,et al.  Clinical review 163: Cardiovascular endocrinology: Low-density lipoprotein size and cardiovascular disease: a reappraisal. , 2003, The Journal of clinical endocrinology and metabolism.

[398]  A. Weverling-Rijnsburger,et al.  Total cholesterol and risk of mortality in the oldest old , 1997, The Lancet.