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Clinical research is vital in developing knowledge geared toward improving future health practices. It is often the only feasible solution to medical conditions where standard treatment has failed. Research can be groundbreaking and progressive but study populations lack diversity, especially regarding demographics such as race, ethnicity, age, and sex. Which begs the question: “Why is diversity important to research?” Simply put, various subsets of people can process the same medication differently. Through the clinical research process (guided by strict safety protocols), researchers gather data on how participants experience the same investigational product (IP). Suppose a clinical trial includes people from many different age, gender, and racial/ethnic groups. In that case, researchers will then have data on how several groups of people respond to the same product based on those differences. When these new products reach the market, doctors will know what works best, what doesn’t, and for whom based on those findings. Through research, doctors learned that it is best to prescribe particular medications based on patients’ ethnicity/racial background when treating hypertension. As we move forward, the clinical research community thrives on increasing the participation of all minority age, gender, and  racial/ethnic groups to improve the safety profile of medical products. The US government must lead this effort through legislation.

At ENCORE, we recognize that to benefit the communities we serve, we must take the steps necessary to best represent ALL in the trials we conduct. However, this requires overcoming numerous challenges, including long-standing mistrust and economic barriers which prevent minority groups from accessing and participating in research.

Even though clinical trials have evolved from historically unethical practices involving minority racial groups to a transparent process where participant safety and protection are paramount, there is still a significant lack of trust on the part of potential study subjects. Especially for those who are dubious, establishing credibility and integrity within clinical research practice is crucial to growing minority group participation. We believe that physicians, especially those who serve ethnically/racially variant communities, play a significant role in achieving Diversity in clinical trials by bridging trust between researchers and minority participants. ENCORE physicians have dedicated their efforts to working alongside primary care physicians and specialists who serve these communities; to provide them with research material relevant to their practice. Doctors then have the information to make informed recommendations on whether a particular clinical trial is appropriate for their patients. Not only are people more likely to be confident in the recommendations coming from their doctors, but doctors find themselves better prepared to help patients who have failed on current therapeutic approaches.

Unlike when seeking intervention via traditional means, economic hindrance isn’t a preventative factor when one chooses to participate in clinical research. Healthcare costs are a significant burden to many; however, all of the investigational medical products available here at ENCORE cost our patients nothing. All study-related materials, evaluations, blood tests, and imaging are done for free. Study participants will never be billed.  Sponsors such as pharmaceutical companies, governments, and foundations fund medical research through study grants. Grants provide the funding to conduct studies at local research sites, so the cost is not transferred to the volunteers. This allows people experiencing financial constraints or without health insurance the opportunity to receive potentially groundbreaking medical treatment at no cost to them. A small monetary compensation is often provided for participants’ time and inconvenience associated with participating in a clinical study. Payment is kept within a reasonable amount to prevent enticement and undue influence on participants.

Despite these steps, we recognize that much more needs to be done to garner diverse research participants in all our trials. Appropriately representing Diversity in clinical trials is an ethical and medical obligation that bounds all stakeholders. Critical players like research sponsors, investigators, referring physicians, coordinators, recruiters, and patients must work collaboratively to achieve this goal. A multi-level stakeholder approach can be more successful than one which addresses a single barrier or involves individual stakeholders. As a research facility, our responsibility in achieving increased Diversity amongst trial participants will build on our investments towards nurturing long-standing relationships. These relationships are between sponsors, community members, our diverse pool of staff and physicians, and our commitment to engagement and learning from diverse patient groups. With this approach, we are confident that trial enrollment will continue to become more diverse and result in a more accurate representation of the people that products are intended to treat.

Albertha V. Lalljie, MBBS, MPH


July 25, 2022 BlogDiversity

Earlier this year, a bipartisan bill was introduced in the US congress to increase diversity in clinical research trials. The DEPICT act, as it’s called, has many major changes to how clinical trials would be conducted. These changes would affect sponsors, the government, and clinical research sites. Sponsors are the companies which develop new drugs and devices in clinical trials.

The bill would require new demographic analyses for drug and device trials by sponsors. Demographic data includes age, sex, race, and ethnicity. Sponsors would investigate the rates of a disease among demographic groups before starting a trial. They would then devise a diversity action plan. This ensures the clinical trial includes a representative sample of the affected population. Let’s say a drug targeted lung cancer, for example. The sponsor would have to find out who has increased chances of getting lung cancer. If they found that Black Americans were at higher risk, they would make a plan to ensure this group was included in any research trials. Plans could include community outreach, specific site selection, and diversity training.

A key aspect of the bill is discovering how to best reach diverse communities. Research sponsors would need to submit annual reports. These would outline how successful their studies were at reaching the demographic goals. If they failed to meet goals, they would give possible reasons they did not. The Food and Drug Administration (FDA) would compile and analyze the reports. The FDA would issue public reports on diversity and enrollment targets. They would also publish justifications for failure to meet targets and recommendations to solve this. Additionally, the National Institute of Health (NIH) would provide outreach. For sponsors, they would issue best practices for increasing diversity. They would engage with minorities to bring awareness of clinical research trials. They would also help local organizations inform their community about research trials.

The final piece of the bill is increasing access. The bill would enhance clinical research infrastructure in underserved communities. The bill provides grants to expand clinical research facilities. These would be in rural areas, on Indian tribal lands, and in federally recognized underserved communities. The grants would help facilities conduct research trials in these areas.

Altogether, this bill addresses the shortcomings of clinical trials in diverse communities. It closes the gap between who suffers from medical conditions and who participates in clinical research trials. It helps find out which methods increase clinical trial diversity. It also helps expand access to clinical trials in underserved communities. There is still a long way to go before this bill makes it to the voting floor, but it’s a good step.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience


Text – H.R.6584 – 117th Congress (2021-2022): DEPICT Act. (2022, February 3).

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As a proven clinical research organization, we take every precaution to ensure the safety of and maximize the value for our research volunteers. Qualified doctors, nurses and study coordinators on staff provide support and care throughout the research trial. Participation is always voluntary. We appreciate the time and effort that research volunteers bring to this important process.

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