Decision theory and the evaluation of risks and benefits of clinical trials.

Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.

Is informed consent necessary for randomized Phase IV 'observational' drug studies?

This article addresses the question about whether informed consent (IC) can be waived in Phase IV randomized observational drug studies (P4RODSs). To do this, it was first necessary to establish that the term P4RODS is a contradiction precisely because randomization necessarily makes a study 'interventional', hence P4RIDS. Once this was established we argued that, based on the right and the harm principles, universally waiving IC in P4RIDS is ethically unjustifiable.

Informed consent and phase IV non-interventional drug research.

Most of the literature on informed consent in pharmaceutical drug research works on the assumption that informed consent is something that is homogeneous and thus can be rendered procedurally universal. This may be justifiable to a certain extent owing to the fact these are all drug trials anyway. Nevertheless, in spite of this general similarity, we also know that the clinical drug development phases are characteristically different, and that phase IV is very different from the other phases because, owing to its postmarketing nature, it is much more varied in scope and in type.