Competing or Complementary?: Ethical Considerations and the Quality of Randomized Trials

Abstract The ethical principles of beneficence (doing the best for one's patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerations and the trial's scientific quality do occur, the ethical considerations must be paramount.

[1]  J. Shepherd Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies , 1994 .

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

[3]  R. Chaisson,et al.  Racial differences in the use of drug therapy for HIV disease in an urban community. , 1994, The New England journal of medicine.

[4]  H. Rubins From clinical trials to clinical practice: generalizing from participant to patient. , 1994, Controlled clinical trials.

[5]  J. Wittes INTRODUCTION : FROM CLINICAL TRIALS TO CLINICAL PRACTICE : FOUR PAPERS FROM A PLENARY SESSION , 1994 .

[6]  P. Lurie,et al.  Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries. , 1994, JAMA.

[7]  T. McGovern,et al.  FDA policy on women in drug trials. , 1993, The New England journal of medicine.

[8]  H. B. Brooks,et al.  Perception of quality of life before and after disclosure of trial results: a report from the Program on the Surgical Control of the Hyperlipidemias (POSCH). , 1993, Controlled clinical trials.

[9]  S. Piantadosi,et al.  Politically correct clinical trials. , 1993, Controlled clinical trials.

[10]  A N Krauss,et al.  Neonatal extracorporeal membrane oxygenation (ECMO): clinical trials and the ethics of evidence. , 1993, Journal of medical ethics.

[11]  T. Wright,et al.  Molecular virology and pathogenesis of hepatitis B , 1993, The Lancet.

[12]  On stopping a trial before its time , 1993, The Lancet.

[13]  A Fletcher,et al.  Implications for trials in progress of publication of positive results , 1993, The Lancet.

[14]  G. Koren,et al.  Maturity of children to consent to medical research: the babysitter test. , 1993, Journal of medical ethics.

[15]  S. Michie,et al.  Anxiety, knowledge and satisfaction in women receiving false positive results on routine prenatal screening: a randomized controlled trial. , 1993, Journal of psychosomatic obstetrics and gynaecology.

[16]  F. Mosteller,et al.  Survival from Localized Breast Cancer: Variability Across Trials and Registries , 1993, International Journal of Technology Assessment in Health Care.

[17]  B. Hart,et al.  The problems and prospects of a health research and ethics committee for undergraduate students , 1993 .

[18]  N. Anthonisen,et al.  Recruiting healthy participants for a large clinical trial. , 1993, Controlled clinical trials.

[19]  John R. Hughes Exclusion of "noncompliant" individuals from clinical trials. , 1993, Controlled Clinical Trials.

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

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

[22]  D. Stewart,et al.  The Effect of Educational Brochures on Knowledge and Emotional Distress in Women With Abnormal Papanicolaou Smears , 1993, Obstetrics and gynecology.

[23]  M. Gail,et al.  Ethical dilemmas in continuing a zidovudine trial after early termination of similar trials. , 1993, Controlled clinical trials.

[24]  A. Dennison,et al.  Who's afraid of informed consent? , 1993, BMJ.

[25]  Caroline S. Fox,et al.  Hormone Therapy To Prevent Disease and Prolong Life in Postmenopausal Women , 1992, Annals of Internal Medicine.

[26]  C D Naylor,et al.  Measured Enthusiasm: Does the Method of Reporting Trial Results Alter Perceptions of Therapeutic Effectiveness? , 1992, Annals of Internal Medicine.

[27]  Sandra K. Davies,et al.  Volunteering for research , 1992, The Lancet.

[28]  W. Vollmer,et al.  Recruiting children and their families for clinical trials: a case study. , 1992, Controlled Clinical Trials.

[29]  S. Ellenberg,et al.  Studying treatments for AIDS: new challenges for clinical trials--a panel discussion at the 1990 annual meeting of the Society for Clinical Trials. , 1992, Controlled clinical trials.

[30]  T C Chalmers,et al.  Cumulative meta-analysis of therapeutic trials for myocardial infarction. , 1992, The New England journal of medicine.

[31]  P. Pettit Instituting a research ethic: chilling and cautionary tales. , 1992, Bioethics.

[32]  B. Hawkins,et al.  Patient and clinic factors predictive of missed visits and inactive status in a multicenter clinical trial. The Macular Photocoagulation Study Group. , 1992, Controlled clinical trials.

[33]  G H Guyatt,et al.  A Consumer's Guide to Subgroup Analyses , 1992, Annals of Internal Medicine.

[34]  M. Stewart,et al.  Doctor-patient communication: the Toronto consensus statement. , 1991, BMJ.

[35]  M Gent,et al.  How should results from completed studies influence ongoing clinical trials? The CAFA Study experience. , 1991, Annals of internal medicine.

[36]  N. Lynöe,et al.  Informed consent: study of quality of information given to participants in a clinical trial. , 1991, BMJ.

[37]  P. A. Mynaugh A randomized study of two methods of teaching perineal massage: effects on practice rates, episiotomy rates, and lacerations. , 1991, Birth.

[38]  M. Gnant,et al.  Prevention of neural tube defects: Results of the Medical Research Council Vitamin Study , 1991, The Lancet.

[39]  Y. Thong,et al.  The social filter effect of informed consent in clinical research. , 1991, Pediatrics.

[40]  U. Waldenström,et al.  A randomized trial of birthing stool or conventional semirecumbent position for second-stage labor. , 1991, Birth.

[41]  R. Deber,et al.  Variations in breast cancer treatment decisions and their impact in mounting trials. , 1990, Controlled clinical trials.

[42]  A W Macara,et al.  Ethical review of multi-centred trials. , 1990, Journal of medical ethics.

[43]  S. Green,et al.  Issues in the design of drug trials for AIDS. , 1990, Controlled clinical trials.

[44]  I Chalmers,et al.  Underreporting research is scientific misconduct. , 1990, JAMA.

[45]  J. Walterspiel Informed consent: influence on patient selection among critically ill premature infants. , 1990, Pediatrics.

[46]  P. A. Kelly,et al.  Readability of pediatric biomedical research informed consent forms. , 1990, Pediatrics.

[47]  A. Herxheimer THE RIGHTS OF THE PATIENT IN CLINICAL RESEARCH , 1988, The Lancet.

[48]  K. Dickersin,et al.  Publication bias and clinical trials. , 1987, Controlled clinical trials.

[49]  D. Hunninghake,et al.  Recruitment experience in clinical trials: literature summary and annotated bibliography. , 1987, Controlled clinical trials.

[50]  C. Soskolne,et al.  Physician response to informed consent regulations for randomized clinical trials , 1987, Cancer.

[51]  J Singer,et al.  The consent form as a possible cause of side effects , 1987, Clinical pharmacology and therapeutics.

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

[53]  R. Yancik,et al.  Selection factors in clinical trials: results from the Community Clinical Oncology Program Physician's Patient Log. , 1987, Cancer treatment reports.

[54]  D. Sackett,et al.  Are the results of the extracranial-intracranial bypass trial generalizable? , 1987, The New England journal of medicine.

[55]  R B Haynes,et al.  Patient compliance and the conduct and interpretation of therapeutic trials. , 1987, Controlled clinical trials.

[56]  E. Thomas INFORMED CONSENT , 1986, The Lancet.

[57]  R. Simes,et al.  Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. , 1986, British medical journal.

[58]  I K R McMillan,et al.  Hazards of bronchoscopy , 1986, British medical journal.

[59]  J. Kanis,et al.  Does informed consent influence therapeutic outcome? A clinical trial of the hypnotic activity of placebo in patients admitted to hospital. , 1986, British medical journal.

[60]  Sheila M Gore,et al.  Human Experimentation: A Guided Step into the Unknown , 1985 .

[61]  J. Lumley,et al.  A failed RCT to determine the best method of delivery for very low birth weight infants. , 1985, Controlled clinical trials.

[62]  T. Craig,et al.  Informed consent as a form of volunteer bias. , 1985, The American journal of psychiatry.

[63]  M. Charlson,et al.  Applying results of randomised trials to clinical practice: impact of losses before randomisation. , 1984, British medical journal.

[64]  C. Baines Impediments to recruitment in the Canadian National Breast Screening Study: response and resolution. , 1984, Controlled clinical trials.

[65]  C L Soskolne,et al.  Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. , 1984, The New England journal of medicine.

[66]  M. Angell Patients' preferences in randomized clinical trials. , 1984, The New England journal of medicine.

[67]  Kim Sh,et al.  Accrual of patients into a multihospital cancer clinical trial and its implications on planning future studies. , 1984 .

[68]  H. Taub,et al.  Readability of informed consent forms for research in a Veterans Administration medical center. , 1983, JAMA.

[69]  Jeannette Y. Lee,et al.  Accrual of radiotherapy patients to clinical trials , 1983, Cancer.

[70]  A. Porter,et al.  Attendance at a breast screening clinic: a problem of administration or attitudes. , 1982, British medical journal.

[71]  J. Goldman,et al.  Inconsistency and institutional review boards. , 1982, JAMA.

[72]  H. Perry,et al.  Can dropout and other noncompliance be minimized in a clinical trial? Report from the Veterans Administrative National Heart, Lung and Blood Institute cooperative study on antihypertensive therapy: mild hypertension. , 1982, Controlled clinical trials.

[73]  S. Kelsey,et al.  National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics. , 1982, Controlled clinical trials.

[74]  W. Waters,et al.  DEVELOPMENT OF AN ETHICAL COMMITTEE AND ITS EFFECT ON RESEARCH DESIGN , 1982, The Lancet.

[75]  J. Bennett,et al.  Cancer patient accessions into clinical trials: a pilot investigation into some patient and physician determinants of entry. , 1982, American journal of clinical oncology.

[76]  L. Roth,et al.  What we do and do not know about informed consent. , 1981, JAMA.

[77]  D. Weiss,et al.  Who drops out of clinical trials—The VA cooperative study experience , 1981 .

[78]  J. Elwood,et al.  POSSIBLE PREVENTION OF NEURAL-TUBE DEFECTS BY PERICONCEPTIONAL VITAMIN SUPPLEMENTATION , 1980, The Lancet.

[79]  A. Read,et al.  POSSIBLE PREVENTION OF NEURAL-TUBE DEFECTS BY PERICONCEPTIONAL VITAMIN SUPPLEMENTATION , 1980, The Lancet.

[80]  J. Wild,et al.  Characteristics of men most likely to respond to an invitation to be screened. , 1979, American journal of public health.

[81]  M. Zelen A new design for randomized clinical trials. , 1979, The New England journal of medicine.

[82]  L. Lasagna Problems in publlcatlon of clinical trial methodology , 1979, Clinical pharmacology and therapeutics.

[83]  L. Wilhelmsen,et al.  A comparison between participants and non-participants in a primary preventive trial. , 1976, Journal of chronic diseases.

[84]  Charles Weijer,et al.  The Ethics and Politics of Human Experimentation , 1995 .

[85]  Workshop on Early Stopping Rules in Cancer Clinical Trials. Cambridge, United Kingdom, 13-15 April 1993. , 1994, Statistics in Medicine.

[86]  C. J. Williams,et al.  Introducing new treatments for cancer : practical, ethical and legal problems , 1992 .

[87]  J. Feussner,et al.  A randomized controlled trial comparing quantitative informed consent formats. , 1991, Journal of clinical epidemiology.

[88]  S. Yusuf,et al.  Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria. , 1990, Statistics in medicine.

[89]  G. Koren Ethical boundaries of medical research in infants and children in the 80s: analysis of rejected protocols and a new solution for drug studies. , 1990, Developmental Pharmacology and Therapeutics.

[90]  D. Tuckett,et al.  Approaches to the measurement of explanation and information-giving in medical consultations: a review of empirical studies. , 1984, Social science & medicine.

[91]  L. Edmunds,et al.  A COMPARISON OF BLALOCK-TAUSSIG, WATERSTON AND GORE-TEX SHUNTS IN CYANOTIC CHILDREN LESS THAN 2 WEEKS OF AGE , 1982 .

[92]  G. Marshall Overview of recruitment to the coronary primary prevention trial. , 1982, Circulation.

[93]  J. Levenkron,et al.  Recruitment using mass media strategies. , 1982, Circulation.

[94]  J. Katz Randomized clinical trials--am I by brother's keeper? , 1981, Journal of clinical gastroenterology.

[95]  Patient participation in a hypertension control program. Hypertension Detection and Follow-up Program Cooperative Group. , 1978, Journal of the American Medical Association (JAMA).