Communicating Clinical Trial Results to Participants

By Nicolette Calcavecchia

When conducting a clinical trial, investigators have ethical obligations throughout the entire course of the study, including the post-trial period. Some obligations may be more obvious during the pre-trial and trial periods, but the post-trial period is more of a “black box” with unseen inner workings, explained Emily Largent, PhD, RN, Emanuel and Robert Hart Assistant Professor of Medical Ethics & Health Policy at Penn Medicine, during a presentation at the IOA's 2023 Sylvan M. Cohen Annual Retreat.

What this means is that investigators don’t always think about their ethical obligations to participants once the trial period ends, but whether it is implicitly or explicitly, some of their decisions – i.e. providing post-trial access to a drug, or disseminating study findings widely, or sharing individual and aggregate results with participants – have ethical implications in the post-trial period.

This poses the following question; why should investigators share clinical trial results?

“Sharing results shows respect to the participant as a person instead of treating them like a mere means,” said Dr. Largent. Additionally, sharing results promotes transparency and investigator accountability, can increase recruitment and retention, and simply respects the fact that most participants want to know their results. The reasons for participant interest in study results can vary. The information that they learn from their results may be medically actionable (i.e. may inform their clinical care going forward) or personally actionable (i.e. may influence their health behaviors or future planning), or it may be relevant to others such as genetic relatives. Some people simply want to exercise their “right to know” information about oneself, or have more altruistic motivation and want to know that their participation in the study informed medical knowledge.

However, it is important to note that not everyone wants to know their study results. When it comes to aggregate results vs. individual results, the nature of obligation to share is slightly different. According to Dr. Largent, the relative consensus among medical ethics professionals is that there is an obligation to share aggregate results and an obligation to volunteer to share individual results with the option for participants to decline to learn the information.

While investigators and research staff are generally highly supportive of sharing results with participants, there are still some barriers to sharing clinical trial results. Dr. Largent mentioned the lack of resources and infrastructure to communicate with participants after a study ends. Figuring out the logistics of tracking down patients, especially if there is a long period of time between the end of data collection and top-line results, lack of clarity about who has the responsibility and the right to share results, and worries about managing emotional reactions to study results are among some of the top roadblocks.

The best process for disseminating information is another consideration. Posting data in public domains and academic publications may not suffice. There is no guarantee that participants know about these resources, can find and/or access them, or will understand them. Some possible formats that may be successful are participant newsletters, webinars or videos, or telephone calls, depending on the nature of the news. Regardless of the format, results should always be communicated in non-technical, easy to understand lay language.

To view Dr. Largent’s full lecture on Communicating Clinical Trial Results to Participants (timestamp - 1:13 - 1:42) , click here.