The ethics of clinical trials

Anaesthesia and Intensive Care Medicine

Volumn 10, Issue 2, 2009, Pages 98-101

  Foëx, Bernard A ^a  

^a MANCHESTER ROYAL INFIRMARY   (United Kingdom)

Author keywords

clinical trial; confidentiality; Declaration of Helsinki; equipoise; ethics; placebo; randomization

Indexed keywords

DRUG; PLACEBO;

BENEFICENCE; CLINICAL TRIAL; COMPETENCE; CONFIDENTIALITY; CRITICALLY ILL PATIENT; CULTURAL FACTOR; EMERGENCY TREATMENT; EVIDENCE BASED MEDICINE; FINANCIAL MANAGEMENT; HEALTH CARE QUALITY; HUMAN; INFORMED CONSENT; JUSTICE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; METHODOLOGY; OUTCOME ASSESSMENT; PATIENT AUTONOMY; PATIENT DECISION MAKING; PATIENT MONITORING; PATIENT PARTICIPATION; PATIENT RIGHT; PATIENT SAFETY; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZATION; RESEARCH ETHICS; REVIEW; RISK BENEFIT ANALYSIS; SYSTEMATIC ERROR; UNSPECIFIED SIDE EFFECT; WELLBEING;

EID: 58949094222     PISSN: 14720299     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.mpaic.2008.10.001     Document Type: Review

References (11)

1. Beauchamp T., and Childress J. Principles of biomedical ethics. 4th edn (1994), Oxford University Press, Oxford 546
2. Singh B.N., Connolly S.J., Crijns H.J.G.M., et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 357 (2007) 987-999
3. Ezekowitz M.D. Maintaining sinus rhythm: making treatment better than the disease. N Engl J Med 357 (2007) 1039-1041
4. Sprung C.L., Annane D., Keh D., et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med 358 (2008) 111-124
5. Lièvre M., Menard J., Bruckert E., et al. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. Commentary: early discontinuation violates Helsinki principles. BMJ 322 (2001) 603-606
6. Mythen M.G., and Soni N. Industry sponsorship. In: Ridley S.A. (Ed). Ethical issues in intensive care (2007), Intensive Care Society, London 94-110
7. Turner E.H., Matthews A.M., Linardatos E., et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 358 (2008) 252-260
8. Kastelein J.J.P., Akdim F., Stroes E.S.G., et al. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 358 (2008) 1431-1443
9. Lenzer J. Unreported cholesterol drug data released by companies show drug is ineffective. BMJ 336 (2008) 180-181
10. Groves T. Mandatory disclosure of trial results for drugs and devices. BMJ 336 (2008) 170
11. Gammon B.D., and Gunarathne A. It's time to reappraise recruitment of South Asians to clinical trials. BMJ 336 (2008) 46