Patient recruitment in diagnostic trials: How more effective tactics boost diversity

Diagnostic clinical studies are, by nature, well-suited for the incorporation of decentralized trial components, particularly when it comes to finding qualified patients to recruit while properly diversifying the participant pool. Diagnostic studies can be designed in a multitude of ways, however, when it comes to reaching the desired patient pools, there are significant benefits that can come with selecting models well-equipped to incorporate decentralized elements. Decentralized clinical trials (DCTs) can offer sponsors the flexibility to choose from a myriad of approaches to patient recruitment. Your diagnostics CRO (contract research organization) should be able to support a decentralized clinical trial recruitment plan right for your type of diagnostic clinical trials

Why patient access is important 

Finding the right patients for diagnosis 

There is a unique challenge that often comes with diagnostic studies and diagnostic clinical trials where the study requires the recruitment of patients experiencing a specific prognosis during a precise window of time. Some clinical studies desire patients who have yet to develop symptoms, other studies may require participants to be within the first several days of exposure or first 24hrs of symptom development (common with a COVID diagnostic test), and most of which need untreated patients to be diagnosed. Therefore, it can be quite challenging to find qualified patients and reach them while they're in this ideal window of time. This is particularly true in clinical research for diagnostic tests for acute illness where patients are unlikely to seek out research centers or state-of-the-art facilities that may be running clinical trials, in order to receive care. 

Addressing disparities in clinical trials 

In 2014, a peer-reviewed study, Racial/ethnic differences in drug disposition and response: review of recently approved drugs, summarized “approximately one-fifth of new drugs approved in the past 6 years demonstrated differences in exposure and/or response across racial/ethnic groups” (Ramamoorthy et al). In 2021, an article in Harvard Business Review stated that “people of color make up about 39% of the U.S. population, these groups represent from 2% to 16% of patients in trials” (Giusti et al). 

A review in the National Library of Medicine stated that racial and ethnic disparities existing within clinical studies can be linked to patient access. This review found “in this cross-sectional study of 3689 adults, 9% were invited to participate in a clinical trial, and of those, 47% participated. Respondents had higher odds of clinical trial invitation if they were non-Hispanic Black, college educated, single, or urban-dwelling or had medical conditions; non-Hispanic Black respondents had lower odds of clinical trial participation” (Williams et al). 

Flexible recruitment models 

Physician-based recruitment models activate various health clinics in locations as geographically specific or broad as necessary for a study to recruit patients into diagnostic studies as they walk in to seek care. These models are particularly useful in studies where ideal patients are located in endemic regions or for acute illness. Patients are often unlikely to seek out research centers or academic facilities for diagnosis and treatment of conditions such as strep, COVID, flu, Chlamydia, pregnancy, Lyme disease, and more. These types of patients are much more likely to seek care from their local care facilities and clinics. By activating those sites in a decentralized trial recruitment plan, diagnostic studies are able to meet patients where they are. This model can commonly be deployed in infectious disease and IVDclinical studies.

Direct-to-patient recruitment offers a wide-cast-net approach where digital ads are targeted at specific demographics and geographies on intentionally selected digital platforms to reach an optimized audience. From there, patients can either be directed to online sites where they can begin enrollment and eConsent or be directed to physical site locations depending on a study's requirements. The right clinical trial recruitment software (or patient recruitment software), usually part of all-in-one decentralized clinical trial software, is essential to this model. Common use cases are seen in liquid biopsy diagnostics, oncology diagnostics, as well as other diagnostic clinical trials.

Utilizing community care facilities for the in-person portions of studies when necessary removes the need for patients to travel long to participate in trials. Further travel requirements can be mitigated through clinical trial technologies and services including mobile nursing and phlebotomy, diagnostic device/test shipment, ePRO and eCOA capabilities, and more. These decentralized components are particularly important for diagnostic studies where the real-world intent would be for patients to use these tests or devices at home. A decentralized trial model can additionally allow sponsors to collect important information about patient experience and use feasibility in real-world settings. Ask your diagnostics CRO where these techniques may be applied as part of a decentralized clinical trial recruitment plan.

Expanding patient access and diversity

In three recent diagnostic studies with Curebase, the percentages of participants reporting to be non-white were 58%, 61%, and 67%. The most recent (2020) FDA summary report on diversity in clinical trials showed the average trials comprise 75% of patients reporting as non-Hispanic white. These percentages show roughly 33%-42% greater diversity in Curebase’s decentralized diagnostic trials than the FDA reported average. 

This can very likely be attributed to the ability of DCT models, coupled with the right patient recruitment software, to recruit qualified patients within the windows of eligibility for symptoms while overcoming geographic restraints, travel requirements, and state-of-the-art health costs which can ultimately limit patient access. 

Learn more about real-life examples where a diagnostics CRO has deployed various decentralized clinical trial recruitment plans in this whitepaper.