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Blacks Underrepresented in Clinical Trials

“We can no longer continue to treat Caucasians as the default or universal patient model.” 
     -Dr, Danielle N. Lee to Ebony Magazine, July 2014 

 

Higher Risk, Different Presentations, but Still Hardly Studied
Despite a nearly equal risk of acquiring the cancers studied, black Americans suffering from cancer are less likely to be included in clinical trails for potentially life saving drugs. A joint research and publication effort by Stat and ProPublica found that out of the 31 cancer drugs that received FDA approval since 2015, blacks represented less than 5% of clinical trial participants.

The study also focused on 3 cancers that are known to afflict blacks more than whites:

  • Multiple Myeloma (an aggressive blood cancer)
  • Small-cell lung cancer (also known as small-cell carcinoma)
  • Prostate cancer

The rate of blacks who are diagnosed with these 3 cancers is higher than whites, yet in drug studies they went essentially unrepresented.

Blacks are diagnosed with blood cancers at a rate greater than two times that of whites, and Multiple Myeloma, one of the most aggressive blood cancers, is no exception. 1 in 5 with the disease are black, but in trials for 4 new Multiple Myeloma drugs (Darzalex, Explicit, Farydak and Ninlaro), black patients made up less than 5% of study participants.

Small-Cell lung cancer, also known as small-cell carcinoma, is one of the most common forms of lung cancer, with nearly 90% of all lung cancers falling under this classification. Per ProPublica, 49 out of 100,000 whites have this form of cancer, while 56 out of 100,000 blacks do. Yet ProPublica also found that for trials of 2 drugs seeking approval to treat small-cell lung cancer associated with a specific gene mutation, less than 2% of participants were black.

Prostate cancer is found in 178 of 100,000 blacks vs. 106 out of 100,000 whites. However, ProPublica cites a University of Michigan study that found that only 3% of study participants were black in 5 trials for new prostate cancer therapies from 2009-2015.


Why are Black Americans Underrepresented in Clinical Studies?
There are several factors that may explain why blacks play such a small part in clinical studies:

  1. A feeling of unease and distrust of medical professionals amongst the black community. Not without good cause: Nearly every expert who notes this opinion points to the Tuskegee Study, a 40 year government study of Syphilis in which black men were lied to about receiving treatment, just so medical experts could study the progression of the disease.
  2. The FDA isn’t requiring an adequate patient sample for the drugs being tested.  They say that studies should represent those whom the drug is intended to treat, but they also argue that they don’t have the legal power to REQUIRE this.
  3. There are economic and personal barriers to joining medical studies. Drug studies require significant unpaid time off work, as well as travel to and from the site of the study.
  4. Drug manufacturers aren’t seeking black participants. Given distrust of medical professionals and the financial and logistical barriers to actually enrolling in a study, drug makers often are not willing to hold up a trial to ensure proper patient representation.


Blacks Misrepresented in More Than Just Cancer Trials
Study results were shared in the June edition of Annals of Internal Medicine that found that doctors have been relying on old and incorrect data about the risks of cardiovascular disease for blacks. These guidelines, called the “2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk,” are considered the standard for physicians evaluating patients at risk of heart attack or stroke. The risk calculator based on these standards has been found to miss the mark on assessing the true risk of black patients who present with symptoms ultimately proven to be associated with adverse cardiovascular events. This is because the guidelines were developed based on data relating mostly to white patients and study participants.

NewsOne.com shares that the National Institutes of Health (NIH) is aware that blacks are underrepresented in studies and that the government organization has said that less than 10% of all clinical study patients are black. This is for clinical studies of any disease, drug treatment, or other medical research.

As quoted earlier, Dr. Danielle N. Lee penned an article for Ebony Magazine in 2014 in which she writes “As we learn more about genetic diversity and variation in responses to environmental cues across ethnic groups, we can no longer continue to treat Caucasians as the default or universal patient model.”

Much research exists to defend the finding that blacks are more likely than whites to die from most major diseases, including heart disease, asthma, and certain cancers. While the reasons behind this are many, ProPublica’s findings that blacks are underrepresented in cancer drug trials compels us to want to know more about what differences in biologic traits, available treatment options, and care efforts are doing to impact this statistic. Perhaps if black Americans were properly represented in clinical studies that determine the safety and efficacy of life saving drugs, more lives would in fact be saved.


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The article based on the ProPublica/Stat study can be found here.

Dr. Danielle N. Lee’s article for Ebony magazine can be found here.