It’s a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro, it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical Co., one patient even hailed Ninlaro as “my savior.”
The Food and Drug Administration approved it in 2015 after patients in a clinical trial gained an average of six months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the U.S. is black, and African-Americans are more than twice as likely as white Americans to be diagnosed with the cancer.
Yet of the 722 participants in the trial, only 13 — or 1.8 percent — were black.
The data for Latinos in clinical trials show Latinos are even less represented than African Americans. Check out: http://www.nhcoa.org/the-importance-of-latinos-in-clinical-trials/, or https://khn.org/news/latinos-left-out-of-clinical-trials-and-possible-cures/.
The FDA should be careful if considering any laws regarding mandatory racial diversity for clinical trials, especially as medicine gets more and more personalized. Perhaps a future drug for an autoimmune condition will only be effective for individuals with certain HLA types or other heritable factors and fulfilling such criteria will not be reasonable. People of (some) African and Sardinian descent come to mind, as they are known to have unique genetic risk factors for autoimmune conditions like hypothyroid and MS that differ from the risk factors found in most other populations. Cancer is another area where genes matter. As a general rule, race should not be considered in inclusion/exclusion criteria for clinical trials in such studies, but selecting for heritable factors may limit the potential for diversity. That said, an effort to include a diverse group of subjects should always be made to the fullest extent possible, and research should not neglect disease phenotypes that are specific to racial minorities.
When the percentage for a sub-set of the clinical trial cohort drops below a level where a statistical judgement of the value of the treatment for that sub-set cannot be made, as seems to be true for so many trials conducted in the USA, some action is needed.
See David Egilman’s comment. How about it? Can we recruit enough subjects in each sub-set? Only FDA can decide. They did it for the pediatric patient population. But may not be feasible for some conditions…
Probably need to look at the size/importance of each sub-set of patients, and the potential impact on their health, on a case-by-case basis.
For example, FDA could require a minimum number of black trial subjects for a disease that diproportionately affects black people, to ensure that the trial is sufficiently powered, statistically, to produce a valid result.
interesting article
The racial, gender, and economic bias is well documented, yet it persists. This is about a lot more than racial diversity, it is about scientific credibility. It is really clear that these drug companies and other researchers attempt to influence the outcomes, by choosing only upper income comfortable, white people, in order to get a better result in their clinical trials. it is no wonder people have no trust for the industry, the process or even for science itself.
The other issue here is that clinical trials or the peddling of them is a new form of pharma advertising, and data collection. They infiltrate patient groups on social media, advertising clinical trials in order to get desperate patients to sign up, and divulge their medical information. The FDA, FTC, and other entities refuse to monitor this type of misleading advertising and violations of privacy. Pharma pays these so called Advocacy Groups, to market their products. Typically the patients income is much more important than their underlying condition. No one is looking at how these deceptive tricks, schemes and racial disparities are effecting the real world data, and exposing patients to more misinformation. Due to the infiltration of industry insiders, promotion of negative marketing schemes, and full bore unmitigated greed, science has been corrupted.
Japan requires data on Japanese patients prior to approval. We can do that.
“It is really clear that these drug companies and other researchers attempt to influence the outcomes, by choosing only upper income comfortable, white people, in order to get a better result in their clinical trials.”
what?