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Establishing Diversity in Clinical Trials
Every time you take a medicine – even if it’s just for a headache – you are benefiting from the results of a clinical trial. By the time a medicine reaches the pharmacy counter, it has withstood rigorous testing to assess its safety and efficacy.
The clinical trials process is lengthy and complex, relying heavily on volunteer participation, and without these volunteers, the development of new medicines would not be possible.
However, groups such as African Americans, Asian Americans and Hispanics are significantly underrepresented in clinical research. According to the U.S. Food & Drug Administration, African Americans represent 12 percent of the U.S. population but only 5 percent of clinical trial participants and Hispanics make up 16 percent of the population but only 1 percent of clinical trial participants. It is important to identify barriers to enrollment and employ strategies to encourage greater participation.1
In order to understand how a treatment affects a patient population, it is important to find volunteer participants from all backgrounds. Inclusion of individuals of varied races, ethnicities, ages, and sex/gender in clinical trials can help to improve the completeness and quality of demographic subgroup data reporting and analysis, making that data more available and transparent for health care providers and patients. This is vital, given that certain demographic subgroups of patient populations can respond differently to therapies.
Pfizer’s mission is to establish diversity in terms of race, ethnicity, age and gender across our research portfolio as a key scientific variable, which will enable us to ensure that our study populations are reflective of the epidemiology of the diseases we target through our medicines.
In order to reach these goals we have incorporated several innovative programs including creation of a real-time dashboard for recruitment tracking, new investigator training programs, new internal and external partnerships and development of our collaborator network.