The Food and Drug Administration has removed webpages about diversity and inclusion in clinical trials for cancer drugs.
The page for Project Equity, a 2021 initiative launched by the FDA’s Oncology Center of Excellence to ensure that cancer drugs were evaluated for approval based on data from a diverse group of study participants, has gone dark.
The program aimed to develop policies to make clinical trials for treatments more accessible to people who had been underrepresented in this research in the past. The removal comes amid the Trump administration’s push to terminate diversity, equity, inclusion, and accessibility programs and initiatives.
According to archived Project Equity pages, historically underrepresented groups included “racial and ethnic minorities, individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services.”
Project Equity wasn’t the first time the agency sought to address inclusivity problems in clinical trials, but it helped lead to the development of formal guidance around “diversity action plans.” That gave the FDA a way to communicate expectations to drugmakers about how clinical trials should be conducted to support a drug approval.
Several guidance documents were offline early this week, but at least one of them has since been restored.
There is a formal process for removing guidance documents, which are also posted in the Federal Register. That seems to have been ignored in this case.
Many in the scientific community have said they will continue their clinical trial inclusion efforts no matter what, says Dr. Lindsay McNair, a clinical research consultant and a research ethicist at Equipoise Consulting.
“This wasn’t just kind…
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