IN PARTNERSHIP
Lowering geographic barriers Traditional site-based studies are inherently limited to participants who live within “reasonable proximity” of a limited set of well-resourced clinical sites. While the specific 70% of potential study participants must travel at least two hours to reach the clinical trial sites. Even at shorter distances, frequent clinic visits can represent a great burden on Additionally, some potential study participants might have a much smaller “reasonable proximity” than others. These may include: • participants and families who can’t take paid leave because they work hourly jobs
• patients with diseases that affect mobility or make travel particularly challenging
• patients who rely on public transport DCT approaches can expand recruitment
beyond study centres by reducing the travel burden on participants and their families. While some clinic visits will likely still be necessary – particularly in therapeutic areas like oncology that require infusion therapies – DCTs can reduce the number of in-person visits by introducing the ability to conduct virtual visits, transmit data through sensors, DCTs also often facilitate in-home visits conducted by trained healthcare professionals who operate as an extension of the research site staff. The presence of home health professionals can provide a sense of support for participants, making it less daunting to take part in the study. Home health professionals can also conduct complex procedures in the participant’s home, further reducing the need for in-clinic study visits.
“DCT models can facilitate direct outreach to new sites and clinicians, unlocking access to new prospective participants and enabling sponsors to include sites that serve diverse patient demographics.”
Increasing awareness Many people never hear about study opportunities in the first place. Patients located farther from well-resourced, go-to study sites are more likely to be receiving healthcare from clinics with little to no experience of research. Clinicians at these research-naïve sites may not be as up-to-date on trial opportunities, making them less able to point their patients in the DCT models can incorporate digital tactics and outreach strategies that spread awareness online and facilitate direct outreach to new sites and clinicians. Doing so unlocks access to new prospective participants and, importantly, enables sponsors to include sites that serve diverse patient demographics.
Enabling real change to recruitment practices diversity in the drug review and approval process. Government reports have highlighted digital tools, such as those commonly applied in DCTs, as useful methods for helping to increase patient access to studies.
By adopting DCT approaches, the industry can answer the call of regulatory bodies while making research participation a realistic opportunity for sites and participants in communities not located near large health and typical study centres allows clinical trial sponsors to make real strides in conducting truly patient- centric clinical trials. DCT elements such as sensors, virtual visits, and electronic clinical outcome assessments (eCOA) allow sites to deliver a trial experience that is less disruptive Ultimately, increasing inclusiveness is a win for all parties involved. Participants receive better access to therapies, research-naïve sites and clinicians have more opportunities to participate in trials, and sponsors receive better, more comprehensive data based on representative patient cohorts participating in studies. While DCTs are not a panacea, I look forward to seeing new data and insights unfold and reveal how DCT approaches can lower these and other barriers to participation.
Outsourcing in Clinical Trials Handbook | 43
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