Rose Marie Robertson, M.D., Chief Science Officer of the American Heart Association, testified at a Food and Drug Administration public hearing Tuesday to address gaps in how certain groups of people are represented in research trials used in drug and medical device approval applications. She also addressed how safety and effectiveness data for these groups is reported to the FDA and eventually made public.
“Sex, race and ethnicity, and age play an important role in how heart disease, stroke, and other forms of cardiovascular disease affect us,” said Robertson in her testimony. “These same factors can cause prescription drugs and medical devices to work differently in women and men, minorities and older people. Yet despite this understanding, women, minorities, and the elderly continue to be underrepresented in medical research studies.”
The hearing was called as part of the Food and Drug Administration Safety and Innovation Act of 2012, signed into law in July 2012. It required the FDA to examine medical product applications for evidence on how they affected certain groups and how the information was evaluated and made public.
The resulting report, released in August 2013, found that although some applications reported research trial results by age, gender and race, the trials actually enrolled few women, minorities or elderly. It also provided evidence that the FDA did not include this lack of evidence during its review process.
“We recognize that there are many reasons why women, minorities and older adults may not participate in clinical research, but research shows that a significant reason why is that they are not being sought out for inclusion,” Robertson said. “While we certainly understand the need to conduct clinical trials in a timely and cost-effective manner, the FDA must also send a clear message to trial sponsors that it expects them to include adequate representation of different demographic subgroups.”
Robertson outlined recommendations for how the FDA could address these issues and highlighted stats about the involvement of women, minorities and the elderly in cardiovascular research:
- Eight of 10 of the prescription drugs withdrawn from the market between 1997 and 2000 posed greater health risks for women than for men. Six had cardiac-related adverse effects, according to a report by the Government Accountability Office.
- 35 percent of participants in cardiovascular research trials are women.
- 31 percent of these studies report their outcomes by gender.
- Minorities were underrepresented in major cardiovascular clinical trials published between 1997 and 2010 – only half of the trials reported racial information.
- African-Americans comprised 3 percent of research participants, although they account for 11 percent of all patients with coronary artery disease.
- More than 50 percent of all trials for coronary artery disease in the past decade did not enroll any patients over 75 years old.
- The geriatric population represented just 9 percent of all patients included in such trials.
“Only by insisting on the availability of subgroup-specific analyses and improving the public availability of the results of this data can healthcare providers and their patients make the most informed decisions about which medical treatment will work best for them,” Robertson said.
The FDA is required to include input from Tuesday’s public hearing to create a plan laying out the steps required to improve the quality and availability of data by demographic subgroups. It will also accept public comments until May 16.
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