Decentralized trials Outsourcing-Pharma connected with SubjectWell CEO Ivor Clarke on how patient recruitment has advanced in recent years, challenges faced in decentralized clinical trial (DCT) recruitment, and advice on how to step up recruitment efforts.
The rise of decentralized clinical trials (DCTs) has transformed the research landscape.
OSP: Could you please talk about some of the ways in which patient recruitment has evolved in recent years? What are some of the new technologies, practices, philosophies, etc., we’ve seen emerge?
IC: Unfortunately, patient recruitment has not changed enough in recent years to move the needle on some of the most important problems facing recruitment:
- Lack of trial awareness: One of the biggest challenges to finding participants for clinical trials is that most people, certainly before the pandemic, didn't even know that clinical trials exist or what they are, for that matter.
- Lack of diversity: The clinical research industry acknowledges a lack of diversity in clinical trial participants and seeks to rectify the problem.
Only 4% of the US population has ever participated in a clinical trial so there's a huge opportunity to expand the reach and impact of trial participation. When we educate and engage the 96% of the population that have never participated, a healthy portion of people will be interested in clinical research if the process is simple.
While there has been a trend toward innovation, such as new technologies used to target patients and an emphasis on novel patient accommodations, the industry has seen low adoption rates.
OSP: How did the arrival of COVID-19 change the game?
IC: Buzz around DCTs and hybrid designs has been around for years; however, it took the in-person restrictions brought about by COVID-19 to accelerate their adoptions. COVID-19 had a huge impact on clinical research, pausing active trials and putting trials in the pipeline on hold. The pandemic forced the industry’s hand, making new technologies and methodologies necessary for trial success.
COVID-19 pushed vaccine trials into daily media coverage, bringing awareness of clinical research to an all-time high. With the news sharing details on vaccine development, efficacy, and approvals, the importance and clinical value of trials was demonstrated to the public.
The pandemic also reinforced the importance of diversity in trials. The lack of diverse representation in clinical trials was laid bare throughout the fast-tracked COVID-19 research. Recent data showed the Black population accounted for 21% of deaths from COVID-19, yet only 3% of Black individuals participated in clinical trials related to COVID-19 vaccines.
OSP: What are some of the key differences in patient recruitment with DCTs and hybrid trials, compared to traditional, onsite trials?
IC: The major advantages to DCTs are untethered recruiting from physical site locations, patient-centric accommodations, and the integration of modern technology, all of which often have the side effect of reducing the role of sites in the clinical trial ecosystem.
Reduced site involvement removes access to the site’s patient list, formerly the main source for participant recruiting. Traditional recruiting utilizes 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. DCTs, however, advertise untethered to site locations, relying heavily on geotargeted digital campaigns with the option to partner with online patient advocacy groups.
DCTs increased recruiting radii and patient accommodations expand trial access and require changes, including centralized referral intake, patient screening and enrollment responsibilities moving away from sites, and the creation of infrastructure to screen large patient volumes without delay (i.e., vaccine trials).
OSP: Specifically, please talk about the reliance on sites’ patient lists, and how the rise of DCTs is changing that.
IC: DCTs de-emphasize the role of sites and remove access to their established patients, which is an integral and traditional source for patients in clinical trial recruiting. Fully decentralized trials also untether the patient relationship from the site.
Traditionally, the recruiting relationship with a patient stops with the referral, passing the responsibility to sites to support the patient through the study funnel. With fewer principal investigators and site coordinators in the mix, decentralized trials shake up the management of patient relationships. However, the high-touch approach previously provided by sites, shepherding patients through the enrollment process, is still needed.
OSP: What are some of the things impacting potential referrals coming from healthcare providers?
IC: Referrals from healthcare providers cannot be relied on to fill trial participation needs. Fewer people rely on GPs or family practice physicians for their healthcare. This usage shift is driven by millennials, America’s largest generation, 45% of whom do not have a regular primary care doctor and opt for the convenience of urgent care instead.
Additionally, at research sites, research coordinators are dependent on the physicians’ referrals, even within their own institution. It is difficult to get information about trials into the hands and minds of physicians that are seeing patients every single day but not necessarily focused on clinical research.
OSP: Do you have any examples of ways in which your company has helped any trial professionals elevate their patient recruitment efforts for a decentralized trial?
IC: SubjectWell’s centralized campaigns help patient recruitment efforts for decentralized trials with our high-touch approach and our existing, expanded access to patients. Our clinical trials marketplace offers immediate access to tens of millions of patients worldwide who have already expressed interest in study participation and who have completed a comprehensive medical profile.
SubjectWell is able to extend the reach of patient recruitment in fully virtual and hybrid trials, leveraging a geographically broad and unrestricted approach. In a recent hybrid COPD trial, SubjectWell brought in qualified patients from 3 times the previous recruiting radius, because the trial incorporated televisits and limited the required in-person site visits.
SubjectWell’s patient recruiters offer a high-touch approach to fill in for the site relationship. We offer warm transfers to centralized screening, send reminders for appointments, and follow-up when referrals go dark. We can support multistep registration and consent processes, transfers across multiple platforms and vendors, and technical support for application installs. In a recent decentralized central nervous system trial, SubjectWell shepherded patients from the first point of contact through to application download, all in one call.
OSP: Can you please gaze into your crystal ball and tell us what you think might change about recruitment, as DCTs become even more prevalent and trial professionals get more used to this brave new world?
IC: Recruitment will evolve to emulate customer acquisition strategies from other industries. In this patient-centric shift, trial sponsors will treat patients like customers, offering greater selection and providing easier access to care.
Patients will be able to choose their method of care from a large number of trials. The industry will need to appeal to patients, articulate each study’s value, and hold patients’ hands throughout the entire enrollment process. Additionally, trials will continue to add patient accommodations inspired by decentralized protocols to reach a more diverse geographic and racial population.
