Module 6 of Adaptive Trial Designs series: Ethical, administrative, regulatory, logistical considerations
The sixth and final part of our year-long training series is now available. This module focuses on important ethical, administrative, regulatory, and logistical considerations for researchers implementing adaptive clinical trial designs.
Nearly a year has passed since we launched our training series on adaptive clinical trial designs —what an outstanding success it has been. We extend heartfelt thanks to the 800+ participants for their enthusiasm and curiosity, as well as to our remarkable speakers who so generously shared their time and expertise. And, of course, a special thank you goes to the dedicated University of Geneva-based team for coordinating this ambitious initiative.
Today marks the release of the sixth and final module in the series. This module focuses on important ethical, administrative, regulatory, and logistical considerations for researchers implementing adaptive clinical trial designs. The insightful lectures by Dr Rieke van der Graaf, Dr Eveline Verheijen, and Dr Lennie Derde are available for free with a myERS account.
6.1 Introducing adaptive trial designs to research ethics committees
There are various ethical advantages and challenges that need to be addressed when presenting a trial with adaptive design elements to a research ethics committee. Ethical challenges include social value, scientific validity (clinical equipoise), fair selection, risk-benefit ratio, informed consent and general and specific ethics guidance on adaptive designs. Practical issues in ethics review are also illustrated.
Presented by Dr Rieke van der Graaf, Associate Professor of Medical Ethics at University Medical Center Utrecht.
6.2 Informed consent in adaptive trial designs
This session discusses ethical issues associated with informed consent in adaptive trial designs. It focuses on autonomous decision making in adaptive (platform) trials, particularly disclosure and understanding of information. Deferred consent in the context of adaptive designs is also discussed.
Presented by Dr Rieke van der Graaf.
6.3 Getting sites ready for APTs
Before launching an adaptive platform trial, it is essential to onboard and train the selected sites in organising logistical processes for participant inclusion, study drug distribution, and sampling. This session offers valuable insights into these critical operational steps.
Presented by Dr Eveline Verheijen, Senior Clinical Trial Project Manager at Ecraid.
6.4 EARL challenges in adaptive designs
Like with any randomised controlled trial, there are ethical, administrative, regulatory, and legal (EARL) challenges in delivering (adaptive) platform trials. This lecture offers a brief recap of some of the concepts in modules 6.1 and 6.2. It describes common EARL hurdles, as well as challenges related to working with the participating sites.
Presented by Dr Lennie Derde, ICU consultant and Assistant Professor at University Medical Centre Utrecht.
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