Patients' rights a case for a Charter of Participant Rights in Pre-Market Drug Trials: the next evolution.

Since the first publication of Medicine and Law thirty years ago, there have been significant international advances in patient rights and participant protections in clinical trials. Despite such advances, there are still alarming reports of actual or perceived breaches in ethical standards by Institutions, Investigators and Sponsors of pre-market drug clinical trials. This is particularly disturbing as these trials involve participants in the testing of an investigational drug before its full safety, effectiveness, and clinical outcomes are understood. Moreover, the study design may randomize participants (recruited because they have specific diseases or conditions) into a group receiving a placebo or comparator drug versus a group receiving the investigational drug. The proposed Charter of Participant Rights in Pre-Market Drug Trials reflects the growing trend towards a participant-centred approach to the implementation and enforcement of participant rights. The development and adoption of the Charter is the next natural step towards the guarantee of rights in pre-market clinical drug trials.