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Clinical trials: Do participants feel safe?

May 10, 2013 College News - Potential participants in clinical trials may not have a clear understanding of the methods used by researchers to ensure the safety of investigational drugs they are given.  That finding is the subject of a new paper from the Clinical Trials Transformation Initiative (CTTI) published in Clinical Trials.

A CTTI collaborative research team headed by Kathryn Flynn, PhD, Assistant Professor of Medicine at the Medical College of Wisconsin (MCW), and an investigator in MCW’s Center for Patient Care & Outcomes Research, conducted a study to assess study participants’ attitudes and beliefs surrounding the safety of investigational drugs and biologics used in clinical trials.

Minimizing the risk to study participants is a key requirement of ethical research; also essential is to respect participants’ autonomy by sharing with them important information about the safety of the study as that information becomes available.  However, little is known about how much study participants actually understand or what they expect from a safety standpoint.

In this study, the researchers conducted focus groups with former study participants and individuals who had never participated in a clinical trial. Focus group members understood clinical research generally, but they had limited understanding of safety monitoring. They had a wide range of expectations about who should monitor and communicate safety information. While it was not a focus of this study, the focus group members spontaneously expressed concerns about potential financial conflicts of interest in monitoring and reporting serious adverse events.

“In general, we noted unease among potential study participants about their safety, and a desire to have more information communicated from sponsors to investigators and research participants,” said Dr. Flynn. “We think that engaging patient advocates in the design of clinical trials might ease some of the concerns expressed in this qualitative study.”

"This is the first study that examines what patients expect their clinicians and themselves to be told about safety information during the conduct of a trial,” said Nancy Roach, patient advocate and chair of the board of directors for Fight Colorectal Cancer. “The chasm between what patients think and what really happens is striking.  It is critical to understand patient expectations if we hope to actually achieve patient-centered clinical trials."

Co-authors of the paper are Judith M. Kramer, MD, MS, Carrie Dombeck, MA, and Kevin Weinfurt, PhD, Duke University School of Medicine,

Established by Duke University and the U.S. Food and Drug Administration in 2007 as a public-private partnership, CTTI comprises more than 60 member organizations working to identify and promote practices that will increase the quality and efficiency of clinical trials.
© 2014 Medical College of Wisconsin
Page Updated 07/23/2013