The Rise of Decentralized Clinical Trials Is Disrupting Traditional Patient Recruitment
Buzz about decentralized clinical trials (DCTs) and hybrid designs has been around for years; however, it took the in-person restrictions brought about by COVID-19 to accelerate their adoption. The major advantages of DCTs – untethered recruiting from physical site locations, patient-centric accommodations, integration of modern technology – all drastically affect the role of sites in the clinical trial ecosystem. Particularly in the area of recruitment, DCTs remove what has traditionally been a primary source for participant recruiting: sites’ patient lists. This change raises the question: Where will trial participants come from when the site recruiting model is minimized by decentralized and hybrid trials?
But trials with decentralized elements are here to stay. Patients like the concierge services, fewer in-person visits, and the technology and mobile apps that reduce their burden of trial participation. In a SubjectWell patient survey from October 2020, the following accommodations were rated as extremely or very important: study medicine delivered to the home (75%), remote communication with doctor (74%), lab samples collected at home (68%), concierge services (67%), and mobile applications (67%). The more-flexible DCTs, the ones that literally bring the study to the patient, make clinical trials more accessible to all patients.
That said, DCTs still need to engage, recruit, and retain patients. Finding and keeping patients in clinical trials is difficult, and recruiting those patients is not getting any easier. Fewer people are being seen at general practitioner or family practice clinics. Of millennials, America’s largest generation, 45% don’t have a regular primary care doctor, opting instead for the convenience of urgent care. While the impact of healthcare providers in referring patients to clinical trials is debated, fewer patients with an ongoing relationship with a primary care physician (PCP) will further lower referral rates to studies.
On one hand, patient recruitment gets increasingly difficult with reduced patient volume through PCPs, combined with DCTs decreasing the utility of site-based patient lists. But on the other, DCTs bring the advantages of increased recruiting radii and patient accommodations that expand trial access. Will the recruiting advantages brought by DCTs be significant enough to overcome the DCT-imposed recruiting challenges, in addition to the challenges that already exist? When decentralized and hybrid trials have fewer sites in the mix, will study teams be prepared with smart, centralized recruitment campaigns? DCTs disrupt recruiting as we define it today, producing a debate as to the nature of recruitment and the source of patients in the new decentralized trial model.
DCTs challenge our current definition of recruiting. Traditional recruiting leverages the site’s patient population, adding local and sponsor-driven advertising to augment the geographically limited patient search – typically on a study-by-study basis. Virtual and fully decentralized trials are not able to rely on existing patient sources or local campaigns to the same extent, further compounding the dilemma of access to eligible patients. Several recruiting challenges and changes bubble to the surface with the decentralized model. With few or no local sites, referral intake can be centralized to larger, possibly mega-sites. Similarly, patient screening and enrollment responsibilities may also move to a new home. When large patient volumes require screening, as is the case for vaccine trials, infrastructure may need to be built to receive and process patients without adding delay. If recruiting involves timing, like finding a patient in flare, trials will need to layer on tracking and communication channels beyond site coordinators. Even the way we find and talk to patients with no geographic limitations changes the type of advertising and outreach used. As local advertising becomes less relevant, partnering with online patient advocacy groups and relying heavily on geotargeted digital campaigns will dominate in the race to find qualified candidates.
DCTs also put ownership of the patient relationship up for grabs. Traditionally, the recruiting relationship with patients stops with the referral, passing the responsibility to sites to shepherd patients though the study funnel. With fewer principal investigators and site coordinators in the mix, decentralized trials shake up the management of patient relationships. Ensuring study compliance and attendance at screening appointments and follow-up visits will require new methods. It may be difficult to substitute the consistency and personal touch provided by sites to pull patients from screening to consent. Perhaps technology (e-consent, web prescreens, digital scheduling) will engage the patient and bridge the gap until a study contact is later assigned. Adding a patient-engagement step with education early in the recruitment process may be enough to keep patient trust and participation interest high.
What can we expect? It’s easy to anticipate a shakeout period as different recruiting vendors and DCT platforms create solutions to address the widening recruitment gap created by decentralized and virtual trials. As the possible solutions have many overlaps and adjacencies, new products, vendors, and technologies will inevitably breed both innovation and confusion. It will become exceedingly important during these times to keep the needs and desires of the patient center stage. The ultimate test of success for the future of decentralized and hybrid designs will be in their ability to reduce enrollment friction, expand access to a broader array of patients, and ultimately reduce the amount of time to last patient in.