Dr Lisa Eckstein1
1University of Tasmania
Data Monitoring Committees (DMCs) play a pivotal role in ensuring the ongoing ethical acceptability of clinical trials, including whether emerging safety or efficacy signals warrant modifying or terminating the trial or specific trial arms. Unlike Human Research Ethics Committees and their international equivalents, DMCs are provided with limited ethical guidance when it comes to resolving their high-stakes decisions. Oftentimes resolution depends upon DMC member discretion based on experience and good judgment. Notably, as the only persons with access to confidential interim data, it is highly challenging for DMCs to seek independent views on any emerging issues involving the ongoing ethical acceptability of a trial.
This presentation will identify key ethical issues faced by DMCs. This will include, for example, the competing and sometimes conflicting roles that DMCs are expected to play in monitoring clinical trials, the diversity of recommended approaches for setting stopping boundaries, and the post-trial responsibilities of DMCs. It will go on to assess the extent to which a convenience sample of DMC guidance documents, including charters, protocols, and statistical analysis plans, can assist with resolving these ethical challenges.
Biography:
Dr Lisa Eckstein is a Senior Lecturer in Law and Medicine/Health Law in the Faculty of Law in the College of Arts, Law and Education. Her area of specialisation is ethical and legal issues associated with medical research, with a focus on clinical trials and innovative technology. Dr Eckstein is also the Director for CT:IQ, a collaborative body that seeks to develop and implement recommendations that will improve the impact, quality and efficiency of clinical trials, leading to more rapid, lower cost and higher quality evaluation of healthcare interventions in Australia.