Broadening participation in clinical trials

By | June 27, 2016

clinicaltrialDiversity in clinical trials is critically important. Each new treatment needs to be tested in a broad, diverse population, because men and women of different ancestries have different responses to both diseases and treatments.  If only certain groups of people participate in clinical trials, it can increase disparities and worsen outcomes for people underrepresented in the clinical trial data.

Until the 1970s, it was common for new medical treatments to be tested only on men. Women, of course, have different hormonal and physical systems and are smaller, on average. Many diseases also have different clinical presentations in women than in men. With women excluded from most clinical trials, doctors lacked important information and could not provide the best quality care. The same situation still exists today for those who have historically been underrepresented in clinical research. While we’ve made progress since 1993, when the National Institutes of Health mandated that women and minorities be included in any government-funded health research, there’s still a long way to go.

#clinicaltrialschampionThis is The Year of Clinical Trial Diversity

To help promote diversity in clinical trials, the FDA has published a number of videos, a blog post, and the infographic (at right). Five of the videos feature Shirley Miller, who is living with sickle cell disease; one features Dr. Luciana Borio, Acting Chief Scientist at FDA; and another is a Spanish-language interview with Cariny Nunez, FDA Public Health Advisor. They share their views on why diversity in clinical trials matters and encourage patients to learn more.

Video 1: Shirley’s Story: How to Find Information about Clinical Trials

Video 2: Shirley’s Story: Getting Access to Cutting Edge Therapies

Video 3: Shirley’s Story: You Don’t Have to be Sick to Participate

Video 4: Shirley’s Story: Diversity is Critical to Making Better Medical Products

Video 5: Shirley’s Story: Diversity is Critical to Making Better Medical Products(LONG VERSION)

Video 6: Dr. Luciana Borio: FDA’s Role in Increasing Clinical Trial Diversity

Video 7: Interview with Cariny Nunez, FDA Public Health Advisor [Spanish]: Part 1, Part 2

Become a clinical trials champion and share this important message with your community. Let’s inspire everyone to learn more about clinical trials!

Lisa Lines

Lisa Lines

Health services researcher at RTI International
Lisa M. Lines, PhD, MPH is a health services researcher at RTI International, an independent, non-profit research institute. She is also an Instructor in Quantitative Health Sciences at the University of Massachusetts Medical School. Her research focuses on quality of care, care experiences, and health outcomes among people with chronic illnesses; emergency department utilization; and person-centered care and patient-centered medical homes, among other topics. She is co-editor of TheMedicalCareBlog.com and serves on the Medical Care Editorial Board. She also serves as chair of the APHA Medical Care Section's Health Equity Committee. In 2015, Dr. Lines was appointed to a 3-year term on the National Quality Forum's Neurology Standing Committee. Views expressed are the author's and do not necessarily reflect those of RTI or UMass Medical School.
Lisa Lines
Lisa Lines

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About Lisa Lines

Lisa M. Lines, PhD, MPH is a health services researcher at RTI International, an independent, non-profit research institute. She is also an Instructor in Quantitative Health Sciences at the University of Massachusetts Medical School. Her research focuses on quality of care, care experiences, and health outcomes among people with chronic illnesses; emergency department utilization; and person-centered care and patient-centered medical homes, among other topics. She is co-editor of TheMedicalCareBlog.com and serves on the Medical Care Editorial Board. She also serves as chair of the APHA Medical Care Section's Health Equity Committee. In 2015, Dr. Lines was appointed to a 3-year term on the National Quality Forum's Neurology Standing Committee. Views expressed are the author's and do not necessarily reflect those of RTI or UMass Medical School.