Clinical trials have traditionally fallen short of enrolling participants that fully represent the demographics of the general population or those experiencing the disease or condition that they are studying. Without research representative of all patients with a disease, it is difficult to determine which segments and sub-segments are assisted by a treatment. These insights are a major resource as we all strive to achieve disease curability and treatment for patients.
Clinical trial participants have most often consisted of white male patients, with underrepresentation of women and people of color, particularly Black and Hispanic patient populations. These groups only represent between 2% and 16% of patients enrolled in clinical trials. Why does this gap persist and what can be done to better enroll underrepresented groups in clinical trials?
Systemic Obstruction
Countless studies have accounted for the causation of lack of Black representation in clinical trials with many factors involved. Direct patient-related participation limitations include transportation, access to trial centers, and socioeconomic barriers such as the need for days off of work and childcare costs. This has real-world effects on individual and public health.
The future of therapeutics relies on clinical trials, and trials for cancer are a key focus. Unfortunately, there is a history of low participation in traditional clinical trials among Black Americans, for whom the cancer death rate is higher than other ethnic groups. For example, Black Americans account for around 22% of yearly multiple myeloma cases, yet trials for this cancer had a median enrollment of only 4.5% for this patient demographic. Across all studies that resulted in an FDA cancer drug approval in a five-year period, Black enrollment was just 7%.
Compared to Caucasians, Black and Hispanic children are at a higher risk for developing food allergies that result in anaphylaxis, yet the American Academy of Allergy Asthmas & Immunology found that these children are also extremely underrepresented in food allergy clinical trials. Trials that reported data on race/ethnicity revealed the following breakdown of participants: 82% Caucasian; 7.6% Asian; 3% African American; 1.2% Hispanic.
Fortunately, there are ways in which clinical trials can account for or work to address these systemic barriers to participation.
Trial design revision driven by Covid-19
In 2019, an Industry Standard Research survey revealed that 38% of pharma and contract research organizations anticipated decentralized trials to make up a significant component of their portfolios, and 48% expected trials to run a trial with the majority of activities to take place in participants’ homes. Further, 68% of the survey respondents had previously used in-home nurse visits to support decentralization. A year later, when revisiting the same questions all of the respondents anticipated decentralized trials to make up a significant component of their research profiles.
Since the onset of the COVID-19 pandemic decentralized clinical trials have accelerated, bringing trial activities to the homes of patients versus patients traveling to trial sites. With 70% of potential participants living over two hours from trial sites, trials that are conducted in the home can increase access and support participant diversity.
The momentum that the pandemic created has ushered biopharma companies and research-service providers to ramp up decentralized clinical trials, utilizing a mostly hybrid design that includes in-person visits and remote assessments. This clinical trial design modification can help to more successfully enroll Black participants into trials at rates reflective of the population being studied.
Previously though, this decentralized or hybrid approach would have been a heavy lift between trial logistics and costs for those conducting the trial. But there are new resources to relieve this burden on pharma and contract research organizations.
Supporting a new clinical trial model
Workpath is a technology platform that powers on-demand, in-home healthcare services nationwide. Our company’s full-service platform includes scheduling and dispatch software, a nationwide network of healthcare professionals, and diagnostic processing and reporting. Workpath can reach 95% of patients across the country and we currently facilitate services for clinical trial operators among a variety of other healthcare companies aiming to meet patients where they are — in their homes.
Workpath’s nationwide specialist network has the ability to support clinical trials by dispatching mobile providers who can conduct assessments, drug administration, and blood draws directly from patients’ homes. This added patient convenience and accessibility is supportive of trial enrollment and retention. Plus, by relying on Workpath’s seamless, end-to-end in-home services, trial operators can avoid the administrative and logistical burden traditionally presented by decentralized trials.
Removing patient obstacles
Traditionally, patient participation in clinical trials has been limited due to factors related to access. Conducting trials that expand access by meeting patients where they are is a promising alternative to the traditional route as they can lift barriers such as childcare, work schedules, and the need for transportation.
As this new model of in-home, decentralized, and hybrid trials spreads, the hope is that these trials can bridge the divide in participation for demographic groups that have been overlooked for far too long. At Workpath, we are focused on helping to close this gap through our in-home care platform that can support research organizations studying high-quality treatments and cures.