Currently more men participate in clinical trials than women, and it is making the results less reliable. Diversity is extremely important in clinical trials, and the FDA is currently pushing for greater diversity.
The FDA established the Office of Women’s Health around 22 years ago, and their mission is to push for the inclusion of women in clinical trials. This was implemented with new policies, science and outreach. This year the FDA put even more focus on recruiting as many women as possible, and Commissioner Robert Califf called 2016 the year of patient diversity.
Current Methods that Encourage Women to Join Clinical Trials
The FDA has spent many years trying to encourage women to participate in clinical trials, and their efforts have helped make progress. They now use regulations, research, health professional training, workshops and social media outreach to encourage women to join them.
The FDA also created the FDASIA 907 Action Plan, which is divided into three main areas – greater participation, increased transparency and quality of data. According to the FDA (AUTHORITY URL: http://www.fda.gov/forpatients/clinicaltrials/ucm407817.htm), this diversity helps to make medical products that are safer and more effective.
Planning for the Future
Despite the FDA’S ongoing efforts, in 2015 only around 46% of clinical trials included women. While progress has been made, the numbers are still disappointingly low. Thankfully the FDA has new ideas that they are starting to implement, including a program called Diverse Women in Clinical Trials which was recently launched, and which implores women to “Make a difference for yourself and for women like you.”
The program will be reaching out to women through social media. The organisers hope that by starting the conversation, they will make women more likely to join trials in the future. If you are a woman who wants to participate in a clinical trial, check out Patient Recruitment Services on websites such as richmondpharmacology.com/specialist-services/patient-recruitment to learn more.
The FDA will also be hosting various scientific webinars and workshops to discuss patient diversity in clinical trials. While the FDA doesn’t know exactly how to improve patient diversity in clinical trials, they are creating various opportunities for women to work with clinical companies in the hopes that it will encourage patient diversity.
For clinical trials to produce better results, more patient diversity is required. This diversity will lead to more accurate, meaningful results.