Clinical trials still have a problem with ethnic minorities
pharmafile | November 8, 2017 | News story | Medical Communications, Research and Development | biotech, clinical trials, drugs, ethnic minorities, pharma, pharmaceutical
Research, published in the Journal of Women’s Health, that aimed to determine the effects of the FDA’s guidance on the inclusion of women and ethnic minorities has found that although representation of women is adequate, more still needs to be done to include a representative proportion of ethnic minorities in clinical trials.
The study was compiled through the years 2013 to 2015, finding that, of the 97.5% of participants who reported race, white individuals made up 77.2% of the total individuals in trials while ethnic minorities made up the remaining 20.3%.
This fails to represent the fact that racial or ethnic minorities makes up close to 40% of the US population. In particular, black/African American participants made up just 6.4% of the studies covered, despite representing close to double that within the general population of the US.
This is of particular concern as the study noted that certain medicines vary in efficacy when used by black/African American patients:
“In a Veterans Administration Cooperative Group study on anti-hypertensives, several classes of antihypertensive agents were found to be not as effective in Black/African American patients. More recently, studies looking at the combination of isosorbide dinitrate and hydralazine in patients with advanced heart failure demonstrated increased survival in Black/African American patients”.
Conversely, the study found that previous problems with underrepresentation of women had been taken into account by trial organisers and that the numbers of women in trials for new drugs were appropriate.
In regards of the trials’ failure to include adequate numbers of racial or ethnic minorities, the report noted a possible explanation:
“Participation of some racial minorities—most notably, Blacks/African Americans—is still not well represented in many programs and remains an area in need of improvement. One contributing factor could be that many clinical development programs are now multi-national, and, hence, a large proportion of patients enrolled were from outside the United States where there were fewer Blacks/African Americans.”
This research builds on a previous study emerging at the end of September that found similar results for the underrepresentation of ethnic minorities and the elderly in cancer clinical trials. The study, published in the American Association for Cancer Research, also found that, using historical data, participation by African-Americans and Hispanics had dropped from the2003-2016 period compared to the 1996-2002 period.
The authors of this latter study concluded that one of the potential reasons for lower participation may be a lower level of trust among ethnic minorities towards healthcare providers.
Ben Hargreaves
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