Clinical Research, We’ve Got a Problem

Provided by Elligo Health Research

Clinical research faces a dilemma that has historically plagued the industry: the lack of diversity in research. The underrepresentation of different races, genders, and classes is largely due to the fact that most trials exclusively enroll white males with easy access to participate. According to a 2019 article in JAMA Oncology, analyzing 230 trials from 2008 to 2018, on average, 76.3% of the participants were white, 18.3% Black, 6.1% Hispanic, and 3.1% Asian. In the period that the authors reviewed, these percentages changed only marginally.

In the wake of the recent coronavirus outbreak, there has been guidance issued from the FDA as well as calls from senators Cory Booker and Bob Menendez for increased diversity in trials testing COVID-19 vaccines and treatments. As a recent CNN article highlighted, among the 350,000 people who’ve registered for these clinical trials, only 10% of participants are Black or Latino. This is a staggering figure given that more than half of the reported COVID-19 cases in the U.S. have been among Black and Latino populations. As mentioned, bringing research to these communities was challenging prior to the pandemic as electronic health record (EHR) data used to identify patients often does not include demographic information, making it difficult to track patients for inclusion. Compounded with the lack of trust minority communities extend to the clinical research community, especially after the Tuskegee study and the unethical treatment of Henrietta Lacks, truly inclusive research has a long way to go.

But diversity is not only a matter of race, ethnicity, and gender. It also spans socioeconomic status, geographic location, community, employment area, and living situation to name a few other factors. Since most trials are typically conducted at research or healthcare centers, one of the largest barriers to participation is transportation to and from a site. As such, reaching populations from lower socioeconomic statuses, which usually includes many racial and ethnic minorities, is challenging for many logistical reasons.

But what if diverse patients could be reached where they live by engaging physicians who are already in these communities? What if underrepresented populations could be included in the clinical research process by visiting the trusted physicians they’ve been seeing for years? Elligo Health Research® has experience facilitating research as care directly in communities, accessing underserved populations by supplementing EHR data with close relationships cultivated with existing practices within their network and using other forms of data, including census data, to identify participants who would be otherwise excluded from the process. This is accomplished by:

  • Recognizing the power of the trusted physician/patient relationship and empowering local physicians to offer research as care to their patients.
  • Providing physicians with the infrastructure needed to seamlessly integrate clinical trial execution into their current practices.
  • Optimizing physician and research workflows by using the only research technology platform designed to work in a real-world healthcare environment.

By continually looking at the challenges of reaching diverse populations, Elligo drives inclusivity in clinical research, allowing patients to gain better access to healthcare and increasing treatment options while improving outcomes.