Clinical Trial Participation Part 1: The first of an ongoing series of articles examining critical issues concerning clinical trial participation.

While clinical trials are the backbone of the development of new and innovative medicines to treat a wide variety of medical conditions in this country, volunteer participation is critical to examine the safety and effectiveness of these new treatments. Despite the importance of clinical trials, research shows that there are many critical issues concerning clinical trial participation. Over the next several weeks, we will be exploring some of these issues and look forward to hearing your own personal thoughts on these too.

The first issue we are examining is the lack of diversity seen in those who do participate in clinical trials. According to the U.S. Food and Drug Administration (FDA), some groups such as African Americans, Asian Americans and Hispanics are disproportionally underrepresented in clinical trials. For example, while African Americans make up 12 percent of the U.S. population, this group represents only five percent of all clinical trial participants. There is the same issue with Hispanics: while this ethnic group represents 16 percent of the population, they only represent one percent of people who participate in clinical trials.

 Importance of Diversity

What people may not realize is that some medications don’t work as well, or cause a plethora of side effects in some groups of people. Women need to take lower doses of certain types of sleep medications because of higher risk of side effects than are seen in men. Some medications that work to lower blood pressure are not as effective in those of African American decent. There isn’t a one-size-fits-all approach to medicine, and that should be reflected in the pool of people who participate in clinical trials to approve new medicines.

What is Being Done

In early March of this year, the Pharmaceutical Research and Manufacturers of America (PhRMA), the national trade group representing pharmaceutical and biotechnology companies, and the National Minority Quality Forum, a group dedicated to improving the quality of healthcare, teamed up to launch a campaign called “I’m In,” designed to raise awareness of clinical research and encourage greater participation in diverse patients populations. The overarching goal of the campaign is to help increase diversity in clinical trials.

The “I’m In” campaign will support the building of the National Minority Quality Forum’s Clinical Trial Engagement Network, a web-based solution designed to help accelerate the inclusion of underrepresented populations in clinical trials. According to a press release announcing this initiative, authorized users will be able to identify potential clinical trial participants by utilizing zip code level mapping of disease clusters and simultaneously identifying and connecting points of care and community resources that can assist with site selection and patient recruitment.

For example, patients with various health issues can sign into the Clinical Trial Engagement Network to search for clinical trials or enter a volunteer pool to be considered for future studies. Physicians who are interested in becoming involved in clinical trials can register as an investigator and make their information known to clinical trial sponsors. Patient advocacy groups also can become involved and make their members aware of these new services.

To learn more about this diversity campaign, you can visit www.JoinImIn.org.

 An Effective Solution

The launch of this campaign is a starting point to help increase diversity in clinical trials, but likely is not the ultimate solution. As a clinical research service provider, I’m interested in hearing other people’s ideas about how it may be possible to increase diversity in clinical trials. Perhaps some of these ideas can be easily implemented in our every day work. Please provide your thoughts, comments, or feedback on this topic so that we can begin a healthy exchange of ideas on this topic.