July 2007, Volume 4 Issue 3

Patient Experience is an EPIC Undertaking

A new national study is hoping to shed light on clinical research from the participant’s point of view. The Experiences of Patients in Clinical Trials (EPIC) study funded by the National Institutes of Health (NIH) will examine volunteers’ experiences before, during, and after they enroll in clinical trials, and assess the differences in their experiences by socioeconomic and insurance status. The results will be used to help clinical researchers better understand why people participate in medical research and what happens to them when they do. The principal investigators on the study are from Massachusetts General Hospital. CISCRP is participating in the project as a co-investigator and as a subcontractor, helping the research team identify, enroll and manage investigative sites.

In order to reach a broad population, EPIC will recruit 1,000 adults in clinical trials for rheumatoid arthritis, depression and/or diabetes at 15-20 sites throughout the U.S. The participants will be asked to complete a 30-minute written survey at three points during their experience: when they enroll in a clinical trial; upon completion of their participation; and six months after they complete the trial. A random sample of respondents also will be contacted by telephone.

Lynn Health Science Institute President and CEO William C. Orr, Ph.D., joined the EPIC study because he believes not enough is known about the people who volunteer for clinical trials. “We know virtually nothing about the natural history of a patient who participates in a clinical trial,” the Oklahoma City researcher observes. “We don’t know why they join, stay, and leave clinical trials, or what happens to them at the end of the study. From the standpoint of the patient, the site, and the industry, the EPIC study will be helpful across the board.”

Learning more about the thoughts and experiences of clinical trial volunteers will provide a deeper understanding of what it means to participate in the clinical research process and lead to positive changes. “This study will give us considerable information about clinical trials from the patient perspective and how to make things better for them,” Orr relates. “If we get information on why patients participate in studies, what they feel, and what they get out of them, it’s going to be very helpful. I really believe in this effort and think it’s very worthwhile.”

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