How FDA Hopes To Get More Women In Clinical Trials
By Ed Miseta, Chief Editor, Clinical Leader
Diversity is important in clinical trials, and one group that has been pushing for greater diversity is the FDA. The FDA is the oldest consumer protection agency in the country, having been formed more than 100 years ago. The Office of Women’s Health in the FDA, established about 22 years ago, has been given the mission of advocating for the inclusion of women in clinical trials and analyzing data for the effects of gender. This is done via policy, science, and outreach. The FDA takes patient diversity very seriously, and Commissioner Robert Califf went so far as to declare 2016 the year of patient diversity.
There are many ways the FDA addresses sex differences and women in clinical trials, and the effort has come a long way. There are now regulations and guidance, regulatory research, assessment of product applications, health professional training, workshops and outreach, and the FDASIA 907 Action Plan.
“The FDA has had to evolve,” says Marsha Henderson, assistant commissioner for women’s health at the FDA, speaking at the 2016 SCRS Global Site Solutions Summit in Boca Raton, Florida. “We have evolved with the science and with public expectations. In 2012, we were asked to review the data on drugs, biologics, and devices to see if there were appropriate numbers of patient subgroups participating in clinical trials and to report on the results. In 2014, we issued an action plan that reported on the deficiencies.”
The plan was divided into three priority areas: Quality of data, greater participation, and increased transparency. A drug trial snapshots website was created by the Center for Drug Evaluation and Research (CDER) and Professional Affairs & Stakeholder Engagement (PASE) group. Starting in 2015, data were included on new molecular entities and approved biologics to determine demographic breakdown by sex, race, and age, and whether there were observed differences on safety and efficacy. Each snapshot contains information about the drug in Q&A format along with a link to get additional information. It is intended to be one tool for consumers to use when discussing a drug’s risks and benefits with physicians.
More Work Needs To Be Done
In 2015, about 46 percent of clinical trials included women. Those are certainly disappointing numbers. It wasn’t that long ago when women of childbearing age were automatically dismissed from trial selection, even though FDA guidance only recommended they not be a part of early phase trials. While progress has been made, much more that needs to be done, particularly when looking at variations in female enrollment by disease and product.
“Cardiovascular disease is currently the number one killer of women,” says Henderson. “People will look at snapshots of data to see how we are doing, but we can always do better. The public is watching, and the transparency is real. Social media is bringing information directly to consumers. We have to be aware of how they will rate us.”
For pharma and the FDA to perform better, greater patient participation is required. That increased level of participation will lead to greater data, more patients in subgroups, and data that is more clinically meaningful. To assist with the effort, Henderson notes her group is now reaching out to women. This year her office launched a program called Diverse Women in Clinical Trials, which asks women to “Make a difference for yourself and for women like you.”
The program will take the message directly to women for the first time by reaching out via social media. By starting this conversation, the belief is women will be more comfortable with the concept and be more open to trials when asked to join one.
The FDA will also be hosting scientific workshops and webinars to discuss best practices. Here, Henderson acknowledges FDA does not have all the answers. By creating opportunities to work with pharma, best practices can be shared.
“We are also providing researcher toolkits for recruitment and retention, which are available online,” adds Henderson. “We are partnering with our sister organization at National Institutes of Health (NIH), and they have a researcher’s toolkit which is now a part of our initiative.”
There is also a series of four online courses that will provide up to 24 continuing education credits. The courses are for pharmacists, physicians, and nurses.
“Coming together is a beginning, and staying together is progress,” adds Henderson. “But working together is success. One of the things we must remember is that science is evolving. Community expectations are evolving, and we need to look at the diversity in our trials. Diversity is not something that happens by accident. It’s planned, so we need to start where we want to finish in mind. We want to give sites and sponsors any tools they need to help them do that.”
Update: The original version of this article stated that, “In 2015, about 26 percent of clinical trials included women.” That has been corrected to read “46 percent.”