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May 8, 2017

FDA Drug Trials Snapshots and Diversity When Testing New Drugs

John J. Whyte, M.D., M.P.H.

 

Did you know that some drugs affect men and women differently? For instance, women are often prescribed only half the dose that men take of the sleep medication, Ambien (zolpidem). Race and ethnicity also make a difference. One type of drug commonly used to treat high blood pressure, angiotensin-converting enzyme (ACE) inhibitors, has been shown to be less effective in African American patients than in white patients.

These are just two examples of why it’s important to test drugs on the appropriate patient populations. This is especially true for drugs we call “novel drugs,” new medicines that have never been used before in the U.S. marketplace. Over the past two years, FDA’s Center for Drug Evaluation and Research (CDER) approved 67 novel drugs. So it’s no surprise that in recent years, representation in clinical trials of certain subgroups, such as people of different ages, races, ethnic groups, and genders, has become of growing interest. To help keep the public better informed, CDER piloted the Drug Trials Snapshots program two years ago to provide easily accessible information about patient representation in clinical trials. Snapshots show who participated in the studies used to approve a novel drug and organize information from the studies by sex, race, and age subgroups. Further, they provide a brief narrative on whether there were any reported differences in how the drug worked by subgroup and whether there were any reported differences in side effects among the different groups. Since January 2015, CDER has published a Drug Trials Snapshot within a month of each novel drug’s official approval date.

Just this week, we released our Drug Trials Snapshots Summary Report, which provides a yearly average of the diversity of participants in the clinical trials for novel drugs approved in 2015 and 2016. It shows for example, that women were represented at a rate of 40 percent in 2015 and 48 percent in 2016 and African Americans were represented at a rate of 5 percent in 2015 and 7 percent in 2016. The report also lays out the extent to which safety and effectiveness data are based on demographic factors such as sex, age, and race. At its heart, this report is an effort to be transparent – to provide information to the public, and actually show the number and participation of men and women, of various races and age groups within the clinical trials. Being able to share more information and facts will help us to facilitate a thorough and robust discussion about clinical trial demographics. Now, anyone can go to the site and see the numbers for themselves in a quick snapshot.

Until the late 1980s, clinical trials were conducted predominantly on men. Much has changed since then. Our Drug Trials Snapshots program and Summary Report underscore FDA’s commitment to enhancing transparency and better understanding of patient representation in clinical trials.

 

Cultural Inclusion and Awareness Series

The Case CCC Minority Accrual Committee (MAC) would like to introduce a new name, Cultural Inclusion and Awareness Series for the Cultural Competency Series.  The new name will allow the Committee to broaden the Series scope and post information which will have more research focus. 

September 19, 2017: Engaging Underrepresented Racial/Ethnic Populations in Clinical Trials

June 15, 2017: Health Disparities Data Widget

May 8, 2017: FDA Drug Trials Snapshots and Diversity When Testing New Drugs

December 1, 2016: SRHEC Debuts Cultural Competency Resource Guide and White Paper

April 5, 2016: National Minority Health Month

December 15, 2015: Case Comprehensive Cancer Center Cultural Competency Series

November 18, 2015: Cultural Competency and the Informed Consent Process

October 14, 2015: October is Health Literacy Month

October 2, 2015: Unconscious Bias: Cancer Clinical Trial Disparities in Racial and Ethnic Minority Populations

August 24, 2015: Revised: Case CCC Clinical Research Brochure for African Americans

July 17, 2015: Reshaping Research: A Guide to Integrating Cultural Considerations into Research

June 19, 2015: What We Really Talk About When We Talk About Food

May 18, 2015: Think Cultural Health

March 30, 2015: Implicit Bias: An Introduction

February 9, 2015: Eliciting the Patient's Experience of Illness through Narrative and Reflection

January 26, 2015: Cultural Competency and the Research Process

January 12, 2015: Understanding Cultural Competency: Definitions and Concepts

December 8, 2014: Operationalizing Culturally Competent Research