« Previous
Next »
Journal of Hepatology
Volume 51, Issue 4
, Pages 792-797
, October 2009
Ethics in clinical research
References
- Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1–33). Available on the web: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2004_726_cons/reg_2004_726_cons_en.pdf (last access February 6, 2009).
- . Limits of add-on trials: antirheumatic drugs. Eur J Clin Pharmacol. 2009;65:33–41
- The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007;146:477–485
- DHHS Food and Drug Administration. 21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule 28 April 2008, effective, October 27 2008. http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480537f08 (last access June 1st, 2009).
- . Does the FDA have the authority to trump the Declaration of Helsinki?. BMJ. 2009;338:1157–1158
- . Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures. Br J Cancer. 2005;93:504–509
- . Clinical trials: active control vs placebo – what is ethical?. Sci Eng Ethics. 2004;10:73–79
- . How can research ethics committees protect patients better?. BMJ. 2003;326:1199–1201
- . Non-inferiority trials are unethical because they disregard patients’ interests. Lancet. 2007;370:1875–1877
- . Does placebo help establish equivalence in trials of new antidepressants?. Eur Psychiatry. 2000;15:1–6
- . Inconclusive messages from equivalence trials in thrombolysis. Heart. 1999;81:675–676
- . Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994;272:122–124
- U.S. Food and Drug Administration (2006) US FDA’S noninferiority stance could slow sinusitis approvals. SCRIP – World Pharmaceutical News 3193: 27.
- Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease. (CHMP/563/95 Rev.1) http://www.emea.europa.eu/pdfs/human/ewp/056395en.pdf (last access June 1st, 2009).
- Committee for Medicinal Products for Human Use (CHMP). Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias. (CPMP/EWP/553/95 Rev.1) http://www.emea.europa.eu/pdfs/human/ewp/055395en.pdf (last access June 1st, 2009).
- . Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297:1233–1240
- . Reporting of age data in clinical trials of arthritis. Deficiencies and solutions. Arch Intern Med. 1993;153:243–248
- . Systematic review and economic evaluation of bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. Health Technol Assess. 2007;11:1–128
- . A literature review on off-label drug use in children. Eur J Pediatr. 2005;164:552–558
- . NSAID trials and the choice of comparators–questions of public health importance. N Engl J Med. 2007;356:328–330
- Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation 1996; 61: 1029–37.
- Mycophenolate mofetil versus azathioprine for prevention of acute rejection in renal transplantation (MYSS): a randomized trial. Lancet. 2004;364:503–512
- . Efficacy and safety of tacrolimus compared with ciclosporin microemulsion in renal transplantation: a randomized multicentre study. Lancet. 2002;359:741–746
- . Tacrolimus and ciclosporin microemulsion in renal transplantation. Lancet. 2002;360:799–800
- . Atypical antipsychotics in the treatment of schizophrenia: systematic overview and meta-regression analysis. BMJ. 2000;321:1371–1376
- . Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009;373:31–41
- . The spurious advance of antipsychotic drug therapy. Lancet. 2009;373:4–5
- Mortality following ventricular arrhythmia suppression by encainide, flecainide, and moricizine after myocardial infarction. The original design concept of the Cardiac Arrhythmia Suppression Trial (CAST). JAMA. 1993;270:2451–2455
- Cardiovascular mortality and noncontraceptive use of estrogen in women: results from the lipid research clinics program follow-up study. Circulation. 1987;75:1102–1109
- The Women’s Health Initiative Steering Committee. Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy. The Women’s Health Initiative Randomized Controlled Trial, JAMA. 2004; 291: 1701–12.
- Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007;357:2109–2122
- . A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes (UGDP). Diabetes. 1970;19:747–830
- . Composite and surrogate outcomes in randomised controlled trials. BMJ. 2007;334:756–775
- . Endpoints in studies on myocardial infarction. Lancet. 2007;369:1430
- Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334:786–792
- DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial. Lancet. 2006;368:1096–1105
- . Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ. 1997;315:640–645
- . Evidence b(i)ased medicine–selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ. 2003;326:1171–1173
- . Initial severity and antidepressant benefits: a meta-analysis of data submitted to the food and drug administration. PLoS Med. 2008;5:e45
- . Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457–2465
- Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:1209–1223
- Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000;343:1520–1528
- . Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet. 2004;364:2021–2029
- . Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ. 2002;325:249–252
- . The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996;124:485–489
- . Quantitative analysis of sponsorship bias in economic studies of antidepressants. Br J Psychiatry. 2003;183:498–506
- A long-term comparison of galantamine and donepezil in the treatment of Alzheimer’s disease. Drugs Aging. 2003;20:777–789
- A multinational, randomised, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer’s disease. Int J Geriatr Psychiatry. 2004;19:5 8–67
- Long-term donepezil treatment in 565 patients with Alzheimer’s disease (AD2000): randomised double-blind trial. Lancet. 2004;363:2105–2115
- ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin converting enzyme inhibitor or calcium-channel blocker vs. diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981–97.
- . Can we tame the monster?. BMJ. 2006;333:7558
☆ The authors who have taken part in this study declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript.
PII: S0168-8278(09)00465-6
doi: 10.1016/j.jhep.2009.07.005
© 2009 European Association for the Study of the Liver. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
Journal of Hepatology
Volume 51, Issue 4
, Pages 792-797
, October 2009
