A Brief History of Inclusion Policies

When we last visited the From Ideas to Treatments series, we were discussing diversity in clinical trials...

Inclusion of all groups is important, but it's taken some time to get federal policies established to focus on getting women and minorities enrolled in clinical research trials.

In the 1970's an Federal Drug Administration (FDA) policy actually barred women of birthing age from participating in trials. Seems counter-intuitive, huh? Why keep women out, when we know it's important to see their reaction to these drugs? Well, in part, the government was worried that their participation would put any unborn children at risk. Given the recently discovered effects of thalidomide, its difficult to fault them for this.

Thalidomide was a drug used to treat nausea, so of course, it was widely prescribed to pregnant women for morning-sickness. It wasn't until a generation of kids was born that the link between thalidomide and birth defects was discovered. This event played a large role in the reasoning behind the FDA ban.

For minorities, by the 1970s, there was a distrust that existed, particularly in the African-American community. It was a distrust for clinical research trials, and it stemmed from the Tuskegee Syphilis Experiment, a horrible event in clinical research history that took advantage of African American participants in the most unethical way.

In the 1980s, the U.S. government realized its mistake in banning women from trials, and began to adopt policies of inclusion for both women and minority populations. This led to the passage of the NIH revitalization in 1993. This act required both women and minorities to be represented in clinical research trials, and charged NIH with defining the policy.

Over the next 5-8 years, the remaining federal agencies sponsoring research followed suit. After receiving a less than stellar report in 2000 by the Government Accountability Office concerning NIH’s implementation of its policies, NIH further revised its policy. This revision specifically called for Phase III trials to include women and minorities in a representative number, and highly recommending analysis of these groups.

In recommending analysis, they also made the point that inclusion, while important, is not the last step. Having the diverse representation is important, but how useful is it if you’re not asking the obvious questions: 1) Do females show a difference in response compared to males? and 2) Do minorities show a difference in response compared to one another or the non-minority population?

In the next two posts in this series, we'll take a look at the answers to both of those questions.


This is Part 10 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home