Wednesday, 13 June 2012 03:11

A Simple Way To Improve Diversity In Clinical Trials

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As I prepared to moderate a panel discussion on provider perspectives for improving diversity in clinical trials, I was reminded of the Occam’s Razor principle — “The simplest explanation for some phenomenon is more likely to be accurate than more complicated explanations.” I was also reminded of another famous saying — “Physician, heal thyself.

It has been widely claimed that racial and ethnic minorities, especially in the United States, are less willing than nonminority individuals to participate in health research. I came across this statement in an academic publication, as well as research which disputes this belief. In the February 2006 issue of PLoS Medicine, Dr. David Wendler, first author of “Are Racial and Ethnic Minorities Less Willing to Participate in Health Research,” conducted a comprehensive literature search to identify all published studies that report consent rates by race or ethnicity. He and eight co-authors identified 20 involving the enrollment decisions of more than 70,000 individuals. They found very small differences in the willingness of minorities, most of whom were African-Americans and Hispanics in the United States, to participate in health research compared to non-Hispanic whites. Most of their findings showed statistical nonsignificant differences between groups — with one exception. For 10 clinical intervention studies, Hispanics had a statically significant higher overall consent rate than non-Hispanic whites, thus contradicting the claim that minorities are less willing to participate in clinical research. If we apply these statistical findings, taking into account the Occam’s Razor principle for simplicity, the conclusion is obvious — physicians need to attend to their own faults, in preference to pointing out the faults of others. Yet, past approaches to improving diversity representation in clinical trials have focused on changing the perception of potential participants, not physicians. This has to change.  

The Unconscious Bias Does Exist
Dr. Augustus White, III, M.D., Ph.D., is the co-author of “Seeing Patients: Unconscious Bias in Healthcare.”  Dr. White identified 13 groups in the United States which receive disparate medical treatment (African-Americans, Native Americans, Asian-Americans, Latinos, prisoners, Appalachian poor, immigrants, disabled individuals, certain religious groups, gays, obese, elderly, and women). Honestly, this should really come as no surprise, when you consider that in the field of medicine about 3% of physicians are African-American, with another 3% being Hispanic. I am sure many clinicians who solicit for clinical trial participation think they are above having an unconscious bias. If this were true, then we wouldn’t have data which shows that minority groups are underrepresented in at least some health research studies.

As a former field sales pharmaceutical representative, I promoted Nuva Ring, a prescription method of birth control. I conducted thousands of presentations to clinicians over the years. One conversation which sticks with me, involved a physician who stated that the product was great, but in the wrong market. In his wisdom, it would be well accepted in Europe. He continued with this assertion even when presented with the study “Multicenter Comparison of the Contraceptive Ring and Patch,” published February 2008 in Obstetrics & Gynecology, popularly known as “The Green Journal” and the bible of practicing OB/Gyns. The study demonstrated the statistically significant preference of the ring over oral contraceptives in the U.S. market. “Well, the study wasn’t done in Beaver Falls [where he was located],” he said. This is true. The study was done in Pittsburgh, of which Beaver Falls is a suburb. Unconscious bias does exist. Conclusion: if you want to increase diversity in clinical trials, focus on clinician training and improving awareness of unconscious bias.


 

2 comments

  • Comment Link Thursday, 14 June 2012 00:38 posted by Rebecca Budd

    Interesting point of view on bias and the misconception that minority groups are less likely to consent to participate in clinical trials than Caucasians. Although your article mentions investigator bias, it fails to point out sponsor bias. Bias can be found throughout the clinical trial process - starting with protocol development, study planning, site selection, patient recruitment strategy, study communications, and so on. Once sponsors make changes to how they view minority participation and the conduct of clinical trials, investigative sites will follow their lead.

  • Comment Link Wednesday, 13 June 2012 08:37 posted by Dave Holly

    Bob,

    I think your "research" is not sufficient for you to make such a conclusion. First of all, you are not establishing any goals for patient population makeup. Nor are you comparing that with the overall racial makeup of the US population.

    Here are the US statistics http://quickfacts.census.gov/qfd/states/00000.html

    Blacks make up just 12.6% of our population. Hispanics are 16.3%. And whites make up 72.4%. How does this compare to the racial makeup you expect in clinical research? Combine this with the "chances" that a potential subject has the condition or indication, and race, required for a trial, and you have a very different situation.

    We can't expect diversity to just happen when there are so many external factors that can impact the outcome. Nor can we just assume that white doctors must be racists to account for your perception that trials are not "diverse" enough.

    Most all trials requiring diverse subject populations host the trial at diverse locations around the country, and sometimes around the globe, to assure a diverse group of subjects. The racial percentages of potential subjects who patronize each investigative site have to do with the racial percentages of people living near each location. Your conclusion of "Unconscious Bias" does not have any real proof.

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