While numerous efforts and approaches have been employed to recruit an adequate number of participants and ensure diversity and inclusion in clinical trials, clinical researchers worldwide continue to face challenges in recruiting and retaining participants. Globally, more than 80% of trials fail to recruit enough participants on time, prolonging studies and increasing their costs. The situation is even worse for Phase III and IV trials, with an average enrolment efficiency below 40%.
At the Indegene Digital Summit 2022, industry experts from Arcutis, AstraZeneca, Trevi Therapeutics, and UC Davis Health shared their insights on efficient and cost-effective recruitment and retention approaches across the clinical trials space. Below are some of the key highlights from the session.
A traditional approach to clinical trials suffers from various operational inefficiencies like identification, recruitment, data acquisition, and follow-ups with participants – all of which contribute to the increase in costs, participants’ burden, extension of trial timelines, and low trial participation.
“New technology can have frame-shift change that can bring in efficiencies for patients and sites - it is like unlocking the space and time dimension. Digital technologies enable us to engage with thousands of patients across the globe, all at once.”- Dr Ashish Atreja, Chief Information and Digital Health Officer at UC Davis Health
Digital technologies can help streamline clinical trial costs and efforts while helping organization move more towards a patient-centric trial experience. Summarized below are some approaches that pharmaceutical organizations are adopting to recruit and engage patients digitally.
While these approaches are truly transformational, the scenario on the ground for sites and patients is quite different. The The DT Digital Tracker 2 report published in 2021 revealed that many clinical trial sites were still reluctant to integrate digital technologies into their processes, and cost, complexity, and finding the right technologies were the main barriers to digital adoption. According to the 2nd edition of the Digital Tracker 3, while trial sites are now more open to adopting digital, concern about patients’ ability to use digital tools is still a big hurdle.
Figure: State of digital adoption in clinical trials
For example, here are two real-world clinical trial cases conducted by UC Davis Health – one during the peak of the COVID-19 pandemic and the other post-pandemic. In the first case, they created a bot for COVID-19 that enabled them to enroll 15,000 patients in the first week, 55,000 patients in four weeks, and one million patients overall. The second case was an automated enrolment and engagement initiative for the National Institute of Health’s All4IBD program where they were able to enroll only 78 patients over two months. So, while they were using better technology since the use cases were different and it was post-pandemic, they witnessed much lesser affinity towards the adoption of digital technologies. It is fair to say that though the adoption of digital technologies seems to be an effective solution, there are multiple barriers that patients, sites, and sponsors still need to overcome before realizing the true value.
“It is not the technology alone but also the patients, the indications, and the site processes that limit the adoption of technology”- Dr. Ashish Atreja, Chief Information and Digital Health Officer, UC Davis Health
Effective dealing with patient enrolment and retention challenges in clinical trials offers pharmaceutical companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce the time to market. To accelerate digital adoption for recruitment and retention in clinical trials, pharmaceutical organizations should: