In March, the “I’m In” campaign was launched to encourage African, Asian and Hispanic Americans to participate in US clinical trials. Since then, several states have shown their support, and taken the opportunity to promote themselves as trials locations.
There is a massive racial bias in US clinical trials. The FDA states that Hispanic and African Americans account for 16% and 12% of the total population, respectively, but only make up 1% and 5% of US trial participants.
One of the clear aims of clinical research, enshrined in GCP guidelines, is to examine as representative a sample of the target group as possible. Where that target group is “average Americans” trials are clearly falling short. The figures are even worse in studies of conditions that disproportionately affect non-white Americans.
According to a recent report in Forbes entitled, Closing the Diversity Gap in Clinical Trials, “African-American men are twice as likely as their white counterparts to die from prostate cancer. Yet they represent just 4 percent of prostate cancer clinical trial participants. Suicide is one of the top three causes of death among Asian-American women under 45 years of age; this cohort constitutes just 1 percent of trials for potential treatments for major depressive disorder. And while the prevalence of diabetes among Mexican-Americans and Puerto Ricans is more than double that of Caucasians, those groups combined represent just 4 percent of diabetes trial patients.”
There is no suggestion that this represents a conscious bias amongst recruiters, but is a likely to stem from a complex mix of factors, such as: the availability of information in the right language about the trials process, the location of trials, low income participants being less willing and able to take time from work, and even lack of sensitivity to different religious beliefs.
The “I’m In” website is a resource for patients to find clinical trials in their area and for physicians, sponsors and investigators to access critical information to help patients. The campaign was set up by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum (NMQF).
Improving diversity in US studies is clearly of great benefit to the development of drugs for use in the country, but I can’t help wondering if it will have an unintended impact on US-funded foreign trials. I wonder what proportion of the almost 10,000 Latin American trials listed on www.clinicaltrials.gov have US funding?
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