In the pharma industry, we are obliged to run clinical trials with new kinds of treatments that might become products. There is a typical sequence in place where at certain stages the new treatment is exposed to humans, for intensely showing proof of safety, efficacy and superiority (to other treatments) of a new product.
So far, an ethnic or gender bias with subjects being included in those clinical trials has been generously ignored for decades. In many trials, the majority of subjects share a similar if not the same background. In many diseases, the typical clinical trial subject has European roots, is more likely a male and below the age of 30.
As a consequence, specificities of sub-pupolations. It is assumed that efficacy and safety of a treatment are the same for everbody (and this actually might be the case for most drugs) … but actually we don’t really know, we have no scientific proof.
But the industry is getting more and more aware of the issue, and trying to recruit with more diversity covered. Where possible and appropriate (e.g. it might not really make sense including female subjects for a trial on a new prostate cancer drug candidate).
Still a lot to learn that we might have missed so far. Some recent articles cover the topic and are quite inspiring to read, especially for CX people working in pharma …
- “When will clinical trials finally reflect diversity?” by Todd C Knepper and Howard L McLeod @Nature
- “Researchers Look for Ways to Make Drug Trials More Diverse” by Brian Gormley @Wall Street Journal
- “The pursuit of patient diversity in clinical trials” by Chris Ross @PMLiVE
- “Paving the Way for Diversity in Clinical Trials” by Sandra Young @WebMD
- “FDA can do more to ensure diversity in clinical trials, experts say — including some constructive badgering” by Zachary Brennan @Endpoint News
- [Video] “From Bystander To Advocate For Diversity & Inclusion” @Life Science Leader
- [Video] “Clinical trial diversity in the Covid-19 era — are we seeing a paradigm shift?” @Endpoints Webinars
- “Seven ways to diversify patient populations in clinical trials” by Kate Owen @Transcelerate
Picture source: The National Pancreas Foundation, pancreasfoundation.org