Ethical Issues in Postauthorization Drug Trials

This project looks at the ethics of post-marketing authorization studies; it studies their informed consent procedures, benefit-risk methodology, the fiduciary obligation of physician-researchers, etc. Compared to earlier trials, post-authorization trials are more heterogeneous and other ethical issues are at play in them. Most research ethics principles have been applied to pre-marketing trials, but few studies look at the ethics of trials that occur post-authorization. This research firstly establishes that informed consent in post-authorization trials may rarely be waived; however, given a substantive justification, the form and procedure of informed consent may vary. Secondly, acknowledging the necessity of a benefit-risk methodology in the evaluation of post-marketing studies, we demonstrate how decision studies may be useful in benefit-risk assessments of clinical trials in general. Thirdly, we establish that the therapeutic orientation is an integral characteristic of post-authorization trials, and hence, a necessary consideration when doing ethics in this phase, such as when doing a benefit-risk evaluation. IRBs, sponsors, regulators and other stakeholders ought to take these results into consideration when defining, designing, doing, and evaluating post-authorization studies.

Results

• Bernabe RD, Van Thiel GJ, Raaijmakers JA, Van Delden JJ. Is informed consent necessary for randomized Phase IV 'observational' drug studies? In: Drug Discov Today, 2011; 16(17-18): 751-4. (journal publication)
• Bernabe RD, Van Thiel GJ, Raaijmakers JA, Van Delden JJ. The need to explicate the ethical evaluation tools to avoid ethical inflation. In: Am J Bioeth, 2009; 9(11): 56-8. (journal publication)
• Bernabe RD, Van Thiel GJ, Raaijmakers JA, Van Delden JJ. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. In: BMC Med Ethics, 2012; 13: 6,6939-13-6. (journal publication)
• Bernabe RD, Van Thiel GJ, Van Delden JJ, Raaijmakers JA. Informed consent and phase IV non-interventional medicine research. In: Curr Med Res Opin, 2011; 27(3): 513-8. (journal publication)
• Ethical issues in post-authorization drug trials (thesis)
• Van der Baan FH, Bernabe RD, Bredenoord AL, Gregoor JG, Meynen G, Knol MJ, et al. Consent in psychiatric biobanks for pharmacogenetic research. In: Int J Neuropsychopharmacol, 2012: 1-6. (journal publication)