Monitoring Committee Structure and Function

[1]  B. Freidlin,et al.  Stopping clinical trials early for benefit: impact on estimation , 2009, Clinical trials.

[2]  Cass Principal Investigators and Their Associates.  Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. , 1984, Journal of the American College of Cardiology.

[3]  J. Robinson.  A lay person's perspective on starting and stopping clinical trials. , 1994, Statistics in medicine.

[4]  J. Wittes.  Behind closed doors: the data monitoring board in randomized clinical trials. , 1993, Statistics in medicine.

[5]  R. O’Neill.  Some FDA perspectives on data monitoring in clinical trials in drug development. , 1993, Statistics in medicine.

[6]  Giuseppe Ambrosio,et al.  Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. , 2012, The New England journal of medicine.

[7]  I. Bross,et al.  Sequential Medical Plans. , 1952 .

[8]  Sarah Parish,et al.  Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2.ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. , 1988, Journal of the American College of Cardiology.

[9]  Ralph D'Agostino,et al.  Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. , 2004, The New England journal of medicine.

[10]  Ailsa E Gebbie,et al.  Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women's Health Initiative Randomized Controlled Trial. Writing Group for the Women's Health Initiative Investigators. JAMA 2002; 288(3): 321-333 , 2002, Journal of Family Planning and Reproductive Health Care.

[11]  R. Campbell,et al.  ACE inhibitors after myocardial infarction. , 1993, The New England journal of medicine.

[12]  P. Canner.  The Coronary Drug Project. Monitoring of the data for evidence of adverse or beneficial treatment effects. , 1983, Controlled clinical trials.

[13]  M. Weir,et al.  The Cardiac Arrhythmia Suppression Trial Investigators: Preliminary Report: Effect of Encainide and Flecainide on Mortality in a Randomized Trial of Arrhythmia Suppression After Myocardial Infarction. , 1990 .

[14]  C. Meinert,et al.  Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. IV. A preliminary report on phenoformin results. , 1971, JAMA.

[15]  Michael A Proschan,et al.  Practical midcourse sample size modification in clinical trials. , 2003, Controlled clinical trials.

[16]  S. George.  A survey of monitoring practices in cancer clinical trials. , 1993, Statistics in medicine.

[17]  D. DeMets,et al.  The Role of an Independent Statistical Analysis Center in the Industry-Modified National Institutes of Health Model , 2001 .

[18]  Lessons From Warfarin Trials in Atrial Fibrillation: Missing the Window of Opportunity , 2006 .

[19]  D. DeMets,et al.  Effect of carvedilol on survival in severe chronic heart failure. , 2001, The New England journal of medicine.

[20]  J. Herson.  Data monitoring boards in the pharmaceutical industry. , 1993, Statistics in medicine.

[21]  CIBIS-II Investigators and Committees.  The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial , 1999, The Lancet.

[22]  M Baum,et al.  Early stopping rules--clinical perspectives and ethical considerations. , 1994, Statistics in medicine.

[23]  J. Stamler.  The coronary drug project. Findings leading to further modifications of its protocol with respect to dextrothyroxine. The coronary drug project research group. , 1972, JAMA.

[24]  C. Meinert,et al.  A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. II. Mortality results. , 1970, Diabetes.

[25]  M. Domanski,et al.  A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure. , 2001, The New England journal of medicine.

[26]  Fach,et al.  Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in-Congestive Heart Failure (MERIT-HF) , 1999, The Lancet.

[27]  David L. DeMets,et al.  Statistical aspects of early termination in the beta-blocker heart attack trial , 1984 .

[28]  Charles Kooperberg,et al.  Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. , 2002, JAMA.

[29]  S. Pocock,et al.  When to stop a clinical trial. , 1992, BMJ.

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

[31]  F. Rockhold,et al.  Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. , 1993, Statistics in medicine.

[32]  David L. DeMets,et al.  Data Monitoring Committees in Clinical Trials: A Practical Perspective , 2002 .

[33]  P. Ridker.  The JUPITER Trial: Results, Controversies, and Implications for Prevention , 2009, Circulation. Cardiovascular quality and outcomes.

[34]  Curtis L. Meinert,et al.  Photocoagulation treatment of proliferative diabetic retinopathy: the second report of diabetic retinopathy study findings. , 1978, Ophthalmology.

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

[36]  D. DeMets,et al.  The agonising negative trend in monitoring of clinical trials , 1999, The Lancet.

[37]  F. J. Anscombe.  Sequential Medical Trials , 1963 .

[38]  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.

[39]  G. Kolata.  Controversy over study of diabetes drugs continues for nearly a decade. , 1979, Science.

[40]  S. Ellenberg,et al.  The use of external monitoring committees in clinical trials of the National Institute of Allergy and Infectious Diseases. , 1993, Statistics in medicine.

[41]  A E Leure-duPree,et al.  Electron-opaque inclusions in the rat retinal pigment epithelium after treatment with chelators of zinc. , 1981, Investigative ophthalmology & visual science.

[42]  Monitoring of clinical trials and interim analyses from a drug sponsor's point of view. , 1993, Statistics in medicine.

[43]  P. Armitage,et al.  Repeated Significance Tests on Accumulating Data , 1969 .

[44]  D Machin,et al.  Monitoring clinical trials: experience of, and proposals under consideration by, the Cancer Therapy Committee of the British Medical Research Council. , 1993, Statistics in medicine.

[45]  J. Crowley,et al.  Data monitoring committees for Southwest Oncology Group clinical trials. , 1993, Statistics in medicine.

[46]  David L. DeMets,et al.  Data Monitoring Committees in Clinical Trials , 2002 .

[47]  N L Geller,et al.  On the choice of times for data analysis in group sequential clinical trials. , 1991, Biometrics.

[48]  D. DeMets,et al.  Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. , 1991, The New England journal of medicine.

[49]  L. Walters.  Data monitoring committees: the moral case for maximum feasible independence. , 1993, Statistics in Medicine.

[50]  G. Burke.  Discussion of ‘early stopping rules ‐ clinical perspectives and ethical considerations’ , 1994 .

[51]  Y Pawitan,et al.  Statistical interim monitoring of the Cardiac Arrhythmia Suppression Trial. , 1990, Statistics in medicine.

[52]  Adam Bagg,et al.  Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer. , 2003, Molecular genetics and metabolism.

[53]  R Sylvester,et al.  A reversal of fortune: practical problems in the monitoring and interpretation of an EORTC breast cancer trial. , 1994, Statistics in medicine.

[54]  D. DeMets,et al.  The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early , 2006 .

[55]  J. Whitehead.  On being the statistician on a Data and Safety Monitoring Board. , 1999, Statistics in medicine.

[56]  C. Meinert.  Masked monitoring in clinical trials--blind stupidity? , 1998, The New England journal of medicine.

[57]  S. Pocock.  Statistical and ethical issues in monitoring clinical trials. , 1993, Statistics in medicine.

[58]  Gordon H Guyatt,et al.  Randomized trials stopped early for benefit: a systematic review. , 2005, JAMA.

[59]  J L Pater.  Timing the collaborative analysis of three trials comparing 5-FU plus folinic acid (FUFA) to surgery alone in the management of resected colorectal cancer: a National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) perspective. , 1994, Statistics in medicine.

[60]  P. Armitage,et al.  Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. , 1976, British Journal of Cancer.

[61]  S. Pocock.  When (not) to stop a clinical trial for benefit. , 2005, JAMA.

[62]  Curt D. Furberg,et al.  Data Monitoring in Clinical Trials: A Case Studies Approach , 2005 .

[63]  Johan Herlitz,et al.  Metoprolol in acute myocardial infarction (MIAMI). A randomised placebo-controlled international trial. The MIAMI Trial Research Group. , 1985, European heart journal.

[64]  K. Swedberg,et al.  Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction. Results of the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II) , 1992, The New England journal of medicine.

[65]  D. Shalala,et al.  Protecting research subjects--what must be done. , 2000, The New England journal of medicine.

[66]  R Simon,et al.  Some practical aspects of the interim monitoring of clinical trials. , 1994, Statistics in medicine.

[67]  D. DeMets,et al.  Increasing the sample size when the unblinded interim result is promising , 2004, Statistics in medicine.

[68]  D. DeMets,et al.  A case report of data monitoring experience: the nocturnal oxygen therapy trial. , 1982, Controlled clinical trials.

[69]  K. Hedenmalm,et al.  The conscientious judgement of a DSMB – statistical stopping rules re-examined , 2007, European Journal of Clinical Pharmacology.

[70]  N. Geller,et al.  Practical issues in data monitoring of clinical trials: summary of responses to a questionnaire at NIH. , 1993, Statistics in medicine.

[71]  S. Goodman.  Stopping trials for efficacy: an almost unbiased view , 2009, Clinical trials.

[72]  R. Souhami,et al.  The clinical importance of early stopping of randomized trials in cancer treatments. , 1994, Statistics in medicine.

[73]  W. Rogers,et al.  Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. , 1989, The New England journal of medicine.

[74]  F. Ederer,et al.  Assessing possible late treatment effects in stopping a clinical trial early: a case study. Diabetic Retinopathy Study report No. 9. , 1984, Controlled clinical trials.

[75]  John Robbins,et al.  National cross sectional survey to determine whether the decision to delivery interval is critical in emergency caesarean section , 2004, BMJ : British Medical Journal.

[76]  Sue-Jane Wang,et al.  Modification of Sample Size in Group Sequential Clinical Trials , 1999, Biometrics.

[77]  H. Robbins.  Some aspects of the sequential design of experiments , 1952 .

[78]  A. Tsiatis,et al.  On the inefficiency of the adaptive design for monitoring clinical trials , 2003 .

[79]  B. Freedman.  Equipoise and the ethics of clinical research. , 1987, The New England journal of medicine.

[80]  S. Pocock,et al.  The data monitoring experience in the Candesartan in Heart Failure Assessment of Reduction in Mortality and morbidity (CHARM) program. , 2005, American heart journal.

[81]  Marc P. Bonaca,et al.  Vorapaxar in the secondary prevention of atherothrombotic events. , 2012, The New England journal of medicine.

[82]  L. Friedman.  The NHLBI model: a 25 year history. , 1993, Statistics in medicine.

[83]  C. O'connor,et al.  Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. , 2007, JAMA.

[84]  C M O'Connor,et al.  Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. , 1996, The New England journal of medicine.

[85]  C. Lewis,et al.  Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study , 2012, Clinical trials.

[86]  Robert Lemery,et al.  Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. , 1992, The New England journal of medicine.

[87]  Diana Elbourne,et al.  Data monitoring in randomized controlled trials: surveys of recent practice and policies , 2005, Clinical trials.

[88]  J. Cui,et al.  Nonparametric Estimation of a Delay Distribution Based on Left‐Censored and Right‐Truncated Data , 1999, Biometrics.

[89]  J. Pater.  The use of data monitoring committees in Canadian trial groups. , 1993, Statistics in Medicine.

[90]  H. Robbins.  Statistical Methods Related to the Law of the Iterated Logarithm , 1970 .

[91]  D. Harrington,et al.  Considerations for monitoring and evaluating treatment effects in clinical trials. , 1984, Controlled clinical trials.

[92]  M. Nam.  Clinical Trial for Antidiabetic Drugs: FDA Guidance for Diabetes Mellitus-Evaluation of Cardiovascular Risk in New Antidiabetic Therapies , 2011 .

[93]  A. Liberati.  The relationship between clinical trials and clinical practice: the risks of underestimating its complexity. , 1994, Statistics in medicine.

[94]  David L. DeMets,et al.  Stopping guidelines vs stopping rules: a practitioner's point of view , 1984 .

[95]  Lippincott Williams Wilkins,et al.  The early termination of clinical trials: causes, consequences, and control. With special reference to trials in the field of arrhythmias and sudden death. Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. , 1994, European heart journal.

[96]  Lippincott Williams Wilkins,et al.  Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Survival data. , 1983, Circulation.

[97]  D. DeMets,et al.  The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. , 1995, Controlled clinical trials.

[98]  M. Buyse.  Interim analyses, stopping rules and data monitoring in clinical trials in Europe. , 1993, Statistics in medicine.

[99]  D L DeMets,et al.  Monitoring of clinical trials: issues and recommendations. , 1993, Controlled clinical trials.

[100]  Thomas R Fleming,et al.  Standard versus adaptive monitoring procedures: a commentary , 2006, Statistics in medicine.

[101]  The case against independent monitoring committees. , 1994, Statistics in medicine.

[102]  Peter Armitage,et al.  RESTRICTED SEQUENTIAL PROCEDURES , 1957 .

[103]  J. Crowley,et al.  Data Monitoring Committees and early stopping guidelines: the Southwest Oncology Group experience. , 1994, Statistics in medicine.