New guidance published in JAMA Oncology looks to ease unnecessary restrictions to address two of the biggest issues in cancer: disparities in enrolling minorities in clinical trials and clinical trials failing to start for lack of enrollment.
Two authors of the piece are FDA doctors, indicating how serious the agency is about pushing for these changes.
The lead author, Dr. David Gerber, Associate Director of Clinical Research in the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern told NBC 5 that the agency is pushing the changes.
The guidance suggests easing up on criteria that inadvertently disqualified people of color.
For example, Gerber says it’s known that cancer immunotherapies rarely lower blood counts but most cancer immunotherapy trials require a minimum white blood cell count.
African Americans on average have fewer white blood cells than the population.
“Numerous studies have shown that among African Americans, white blood cell counts on average are lower than they are in a white population. So that’s why completely through unintended consequences, you may be disproportionately excluding those individuals from certain clinical trials,” said Gerber.
Other suggestions ease restrictions on people who’ve had cancer before and may need access to a trial for a different form of cancer.
“We’ve also seen cancer clinical trials become more complicated, more procedures and more requirements, once people do qualify to enroll. For those reasons, it may be difficult in the first place to even open or offer a clinical trial and some healthcare systems that can’t support that type of complexity. Even in locations where a trial is available, there are a lot of extra requirements that may be difficult for certain patients to commit to participate in,” said Gerber.
It’s expected the FDA will create a formal draft of the guidance.