FDA is strongly advocating for introducing diversity into clinical trials by including women in them and analyzing data in terms of gender-based effects.
Established over a century ago, FDA is the oldest agency in the USA specializing in consumer protection. The FDA’s office of Women’s Health is pushing for this diversity through science, policy and outreach, and actually went as far as declaring 2016 a patient diversity year. In order for FDA and pharma industry to perform better, patient participation in clinical research and trials should be high.
Clinically meaningful and more reliable data can be obtained through greater number and diversity in subgroups, and increased level of participation in them. The more people participate, the more subgroups they form, and the greater data it brings.
So far, FDA has been addressing women and sex differences in clinical studies in a variety of ways:
- Regulations and guidance
- Assessment of product application
- Regulatory research
- Workshops and outreach
- Health professional training
- DFASIA 907 Action plan.
The department for women’s health at FDA believes that their organization has to develop and change with public expectations and the science. Thus, in 2012 they were asked to review data on drugs, devices, and biologics in terms of patient subgroups involved in clinical research. The results of this research were presented in an action plan issued in 2014 which reported on the revealed deficiencies.
The plan addressed three major areas:
- Increased transparency
- Greater participation
- Quality of data
The Professional Affairs and Stakeholder Engagement group (PASE) and Center for Drug Evaluation and Research (CDER) launched a website for drug trial snapshots. This website is designed to be a succinct tool for consumers and physicians to refer to when considering a drug’s benefits and risks.
Every snapshot on this website contains information about the drug which is presented in question-and-answer format, and contains a link leading to more detailed information. Since 2015 the website features clinical study data referring to new approved biologic and molecular entities. They are classified by demographic breakdown by race, sex and age. It also contains information on observed differences in efficacy and/or safety in the mentioned terms.
The thought that people are looking at those snapshots, rating and spreading them among consumers through social media, make the industry strive to do better and better. For instance, women are traditionally interested in new drugs and technologies in treatment of such number one “killers” as cardiovascular diseases and many others.
How FDA Encourages Women to Participate in Medical Research
In 2015, women were involved only in about 26 % of clinical research – certainly a disappointing number. Shortly before, women of childbearing age were altogether banned from trial selection according to an FDA guidance that recommended women to be dismissed from (only!) early phase trials.
However, in 2015, the FDA Office of Women’s Health calls for women to “Make a difference for yourself and for women like you” through launching the Diverse Women in Clinical Trials program.
The program’s message is delivered directly to women via social media. The reason to start this conversation was to make women more comfortable with the concept and become more open to the opportunities of participating in trials when asked to do so.
With the same aim of raising awareness and discussing best practices, the FDA hosts scientific workshops and webinars. Working with pharma companies in this format, this organization is ready and open to best practices to be shared. Thus, partnering with National Institutes of Health (NIH), FDA uses their researcher’s toolkit. Their own recruitment and retention researcher toolkits are also available online for other initiatives to use.
Besides, FDA provides online courses designed for nurses, pharmacists and physicians, with opportunities to obtain up to 24 continuing education credits.
Progress made in the area of involving women in clinical studies is apparent, but still there is much to be done especially in terms of variations in female environment by product and disease.
In the world where both science and community expectations are evolving, coming and staying together of such stakeholders as FDA, NIH and the like is crucial. Only through working together and maintaining sufficient diversity success can be achieved. And in order to attain a sufficient level of diversity, these organizations are willing to provide sites and sponsors with any tools they need.