Systems and Regulatory Issues

The Wednesday AccrualNet Post (5-16-2012): What happens to clinical trial participants after a study ends?

Last Updated: Aug 30, 2012

Originally posted by: Anonymous on the former AccrualNet site on May 16, 2012.

 

 

Clinical trial participants rarely have contact with research staff after the study closes. For many patients, particularly those who did not experience a personal benefit from the study, this may feel like abandonment and leaves them wondering if their participation mattered. Most study volunteers (over 85%) never receive information on their participation in clinical trials. As a result, those volunteers may be reluctant to participate in future trials or recommend trial participation to others.

 

Studies show that volunteers want to learn about the outcomes of the clinical trials in which they have taken part and that investigators are highly supportive of communicating trial results to participants. However, few institutions have mechanisms for communicating those results in nontechnical, easy-to-understand language. This is a missed opportunity to build a stronger connection with study volunteers after their participation has ended and improve long-term trust in the clinical trials enterprise.

 

A recent posting on AccrualNet describes a successful attempt at communicating trial results to volunteers. The investigators developed a routine, multistep process that translates technical trial results summaries into lay language and engages institutions to distribute lay summaries to their volunteers.

 

 

Some questions to consider:

 

  • Do you believe that communicating study results is an ethical responsibility of research teams?
  • Have you discussed communicating trial results to participants with investigators at your institution?
  • Do you believe that systematic reporting of results in lay language would improve trust in the clinical trials enterprise and potentially improve future recruitment?

 

We look forward to discussing your thoughts!

AccrualNet Team

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Originally posted by: ermeter on the former AccrualNet site on May 17, 2012.

I believe it is our obligation to share the results with the participant. We generally do this at their next follow up apt, unless it is urgent information. SWOG is working on lay protocol summaries for participants of the study results. I believe CALGB does this as well.

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Originally posted by: linda on the former AccrualNet site on May 17, 2012.

Thanks for your comment. Its great to hear that the cooperative groups are moving in this direction!

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Originally posted by: memaw on the former AccrualNet site on May 30, 2012.

I believe it is imperative that study results be communicated to not just the research community, but to participants and the general public. For too long there has existed a mystique applied to research that leads to distrust and lack of acceptance of the benefits of participation in clinical trials. Keeping it simple and accessible should be the rule, not the exception. SWOG and CALGB should be applauded for moving in the right direction that will establish a connection that could enhance future recruitment efforts.

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