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Oct 17, 2019

MRCT Center Bioethics Collaborative

10:00 AM to 3:00 PM

Location: Ropes & Gray, Boston, MA

Discussion topic: Exploring the Ethics of Complex Clinical Trials

Novel clinical trial designs are considered to render research more efficient and ethical. Adaptive trials, for instance, utilize incoming data to modify the study by amending study arms and other key aspects of study design based on the ongoing collection of data. Such innovative designs often implicate important ethical issues related to informed consent, clinical equipoise, and others. For example, some trials adapt randomization based on incoming data in the hopes of maximizing therapeutic benefit for participants. In these cases, does clinical equipoise persist when treatment allocation changes to favor one arm? At what point is equipoise sufficiently disturbed to render the study unethical? Is the investigator obligated to inform a potential participant that they may have a better chance of receiving effective treatment if they delay enrollment? These ethical concerns are further complicated when adaptive designs are incorporated into platform/umbrella trials that test multiple therapies on multiple populations. IRBs, investigators, and sponsors contend with the complexity of these designs, but no comprehensive approach to clarifying the multiple ethical concerns, or advancing a synthesis or framework to address them, has been advanced. Further, whether and how the IRB should provide ongoing ethical oversight during the course of an approved trial is sometimes unclear, given the inherent uncertainty about how adaptive studies will unfold at time of initial IRB review.

For more information, please contact Walker Morrell.