Seeking to increase the participation of women and minorities in all phases of clinical trials, along with greater reporting and analysis of gender differences, Phyllis Greenberger testified at an FDA hearing yesterday. She presented a series of recommendations and changes to how the agency handles the collection, analysis and availability of demographic subgroup data in applications for FDA-regulated medical products.  

Greenberger is president and CEO of the Society for Women’s Health Research, which has advocated for more research into biological differences and for the reporting and analysis of gender and ethnic differences to help transform science and the quality of care.

“During the last two decades, there have been many advances and tremendous discoveries in how diseases and illnesses impact women differently, disproportionately and exclusively from men,” said Greenberger. “Nevertheless, women and minorities remain chronically under-represented in medical research. “

She cited the NIH’s efforts to recruit and retain women and minorities in phase III trials, but said it does not extend to earlier phases or to basic research, which garners the vast majority of funding. Biological and physiological differences and hormonal fluctuations play a role in the rate of drug absorption, distribution, metabolism and elimination, she said, as well as the ultimate effectiveness in females compared to males.

“This should be discovered in the clinical trials, not after a drug reaches the marketplace,” said Greenberger.

She cited the FDA’s order, early last year, that the manufacturers of sleep medication Ambien lower the recommended dose for women after a series of clinical trials and driving simulation studies revealed the drug’s active ingredient stayed in women’s systems longer,  impairing their alertness after waking up, including the ability to drive.

Among the Society’s recommendations to the FDA:

• Establish disease-specific registries with dedicated funding to encourage those affected to sign up for medical studies and include incentives to keep them engaged in the research process
• Women, minorities and the elderly should be included in all phases of clinical research
• Labels should inform these populations when they are using drugs or devices that have not been sufficiently tested on them
• Establish training for all reviewers to look for gender differences and other demographic data, along with re-training at regular intervals
• Drug and device applications that include the appropriate subpopulation representation should be put on a fast track for approval; applications without these groups should be rejected, as post-market surveillance should not substitute for what may be discovered in the pre-market approval process.

Greenberger also urged the FDA to work with patient groups and sponsors to address existing knowledge gaps to capture all potential information in a clinical trial. If new drug applications must include appropriate subpopulation representation and analysis, clinical trial participation will change at all phases and less will be discovered post market, often years after approval and use.

“Facts regarding sex differences,” she said, “such as women suffering more side effects and more adverse events, should not be discovered post market.” 

—Ronald Rosenberg, CenterWatch Staff Writer