Clinical trials require human volunteers to assess medical products like devices, vaccines, or medications for efficacy and safety. For health equity to be achieved, it’s imperative that clinical trials include people from diverse backgrounds so as to represent the global population of patients using the products.
Unfortunately, clinical research does not always sufficiently include persons from ethnic and racial minority groups. This underrepresentation is alarming, as research shows variances in effectiveness. This article examines how digital capabilities, such as decentralized clinical trial (DCT) technology, can help to improve patient diversity in clinical trials.
In order for clinical research to benefit all people, clinical studies must have an accurate representation of participants who will be using the product. People of varying age, race, and ethnicity will have different reactions to the same product, and these reactions must be accounted for in order to improve outcomes for a diverse group of patients.
- Example 1: In the United States, children of African American and Puerto Rican descent do not react well to the common asthma drug Albuterol, even though asthma is most prevalent among children in these groups. But during clinical trials for this treatment, most participants were of European descent—a sobering example of the need to diversify trial participants for greater treatment efficacy. Furthermore, genetic, socioeconomic, and environmental factors must be considered in the pharmacotherapeutic response to asthma medications.
- Example 2: African Americans have a higher occurrence of high blood pressure and associated conditions (such as heart attacks and strokes). But African Americans have largely been underrepresented in clinical studies involving drugs that treat high blood pressure, and cardiovascular outcomes for this group remain worse than those of their White American counterparts.
What these examples highlight is the continued lack of diversity in clinical trial participants. This underrepresentation was further demonstrated during the COVID-19 pandemic, and it has taken the clinical trial industry until now to address this systemic problem and lift barriers to participation.
A catalyst of recent initiatives around strengthening participant diversity is the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. This bill, meant to increase clinical trial diversity, was introduced in February of 2022. It requires greater demographic reporting, and provides underrepresented communities with resources that make clinical trial participation more accessible.
Lifting barriers through decentralized clinical trials
The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers to entry that may have prevented people of diverse racial and ethnic groups from participating. Some of these advantageous DCT offerings include:
- Removing barriers attached to scheduling and geography, therefore increasing patient enrollment, recruitment, engagement, and monitoring—widening the patient pool.
- Giving patients the option to participate from their homes or another convenient location rather than traveling to a trial site, effectively lowering the burden of time, cost, and convenience.
- Advancements in technology helping to foster stronger relationships between participants and providers, increasing patient trust and leading to better recruitment and retention.
Why Clients Select Medable’s DCT Platform
Recently, GlaxoSmithKline (GSK) partnered with Medable, selecting their DCT platform due to its digital capabilities that support diversity and inclusion. With a track record of success, Medable is known for their flexibility to deploy modern, patient-centered clinical trials. This includes:
- Digital & DCT Screening: Screens patients remotely, no matter their location.
- eConsent: Allows consent to be given remotely, expanding trial access to study participants.
- TeleVisit: Offers the experience of visiting a clinic, but from a remote setting.
- eCOA & ePRO: Securely collects and processes study data, improving the patient experience and data quality.
- Remote Patient Monitoring: Encompasses a myriad of approved instruments used to collect patient data outside a clinical setting.