The NIH Revitalization Act was introduced by congress and enacted into law in 1993, the Act is supposed to encourage an increase in the inclusion of Monitories and Women in Clinical Trials. Basically, the NIH Revitalization Act requires the inclusion of minorities and women in clinical research funded by The National Institutes of Health (NIH) so that this group (minorities & women) are not under-represented in clinical trials.
What has happened since 1993? Not enough. Of note, it has been reported that “The reporting and analyses of data based on minorities in clinical trials remains inadequate”. In the early 2000s it was determined that approximately 10,000 clinical trials were funded by the NIH however, only approximately 150 out of the approximately 10,000 clinical trials focused on a particular ethnic or minority population. Of course, the requirement of the law is that the appropriate inclusion of minorities and women be represented. It does not require that clinical trials be exclusively focused on minority recruitment. Many cancer/tumor types continue to be a challenge to treat, “Hispanics and blacks have a participation rate of just 1.3 percent in cancer clinical trials” which is less than the 2% target that the National Cancer Institute focuses on for the inclusion of the minority population in their clinical trials. “Cancer is a growing burden particularly in states with diverse populations, such as in California, Hawaii, New Mexico and Texas exist”, every effort should be made to increase recruitment of monitories in Cancer Clinical Trials.
It is important to realize that one should not try to change attitudes regarding minorities participating in clinical trials but try to improve access and understand the barriers minorities may be faced with. We have had better success in increasing the number of women in clinical trials.
As you are aware, to include women in clinical trials allows the drug developers and researchers to better understand the drug toxicities by gender and how the drug is metabolized in females. “Cardiovascular disease is the number one killer of US women, and it affects men and women differently at every level, including symptoms, risk factors and outcomes. But only one-third of cardiovascular clinical trial subjects are female and only 31% of cardiovascular clinical trials include women”. Although, 31% is not at all where researchers would like to see the percentage, it has increased and hopefully the number will continue to increase.
This blog just scratches the surface with regard to this topic but it is obvious that “the proportion of minorities in clinical research remains very low and is not representative of the U.S”.