Diversity In Clinical Trials

Clinical research is vital in developing knowledge geared toward improving future health practices. Research can be groundbreaking and progressive.

"People may experience the same disease differently. It is essential that clinical trials include people with a variety of lived experiences and living conditions, as well as characteristics like race and ethnicity, age, sex, and sexual orientation so that all communities can benefit from scientific advances." -National Institute of Mental Health, nimhd.nih.gov

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 of different ages, genders, 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 does not, and for whom based on those findings. Through research, doctors have learned that it is best to prescribe particular medications based on patients' ethnicity/racial background when treating hypertension. Therefore, as we move forward, the clinical research community thrives on increasing the participation of all minority racial/ethnic groups, ages, and genders to improve the safety profile of medical products.

At ENCORE, we recognize that to benefit our communities; we must take the steps necessary to represent ALL in our trials best. This requires overcoming numerous challenges, including long-standing mistrust and economic barriers which prevent minority groups from the benefits of participating in clinical trials.

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 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 is not a preventative factor when one chooses to participate in clinical research. Healthcare costs are a significant burden to many; however, most investigational therapies available here at ENCORE are at no cost to the participants. All study-related medical evaluations, blood tests, and imaging are also at no cost to the participants, and they 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. Additionally, a small monetary compensation is often provided for participants' time and travel associated with participating in a clinical study.

We recognize that more needs to be done to garner diverse research participants in all our trials as 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 the 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. 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