Beyond the keywords: What exactly goes into recruiting and engaging patients digitally?

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%.

How are organizations approaching digitization for clinical trials?

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.

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.

• Keeping patient centricity at the core - At the core of addressing recruitment and retention is ensuring the clinical trial process puts the patient first. Farrell Simon, SVP - Head of Commercial and Strategy at Trevi Therapeutics says, “Our aim is to focus on the participant journey and not just on the patient journey such that we can simplify the operations and design trials that patients want to participate in, easily engage in and see the benefits of giving back to the scientific community.”
• Rethinking data collection in a digital era - Digital health technologies already enable user-friendly measurement of participant health markers, including physical activity, sleep, heart rate, medication adherence, and respiration patterns/rate. Cristina Duran, Chief Digital Health Officer - R&D at AstraZeneca says, “Almost 70% of the data collected from studies at AstraZeneca, could be collected from homes with the help of new clinical trial validated devices.”
• Driving powerful outcomes with artificial intelligence and machine learning - Pharmaceutical organizations are harnessing artificial intelligence and machine learning capabilities to enhance their study design, operationalize their study plan, enhance their trial recruitment ¹, and mitigate risks with practical solutions.
• Building community – This is another effective way to build patient engagement using social media. The community’s purpose is to have members from all over the world, create awareness, and support each other while keeping the patient community engaged through social channels. Nakul Vyas, Head of Data and Digital Innovation, Arcutis said, “We started building communities much ahead of phase II/phase III clinical trials that helped raise awareness amongst the participants.”
• Delivering a unified experience – Organizations are rolling out single apps or platforms that make patient recruitment and engagement activities easier. For example, technological interventions have made it possible to schedule appointments on the phone or engage in video-based telehealth visits with healthcare professionals. Cristina Duran, Chief Digital Health Officer, R&D, AstraZeneca says, “Use of more digital tools doesn't necessarily mean a better patient and site experience, it's more complex unless the experience is unified. The challenge is to work with multiple parties yet provide a unified experience. We have been focussing on creating one app for one clinical trial.”

Digital Adoption – The reality

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.

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.

Conclusion

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:

1. Encourage a shift in mindset toward digital approaches, which are still not applied at scale in clinical research.
2. Define clear KPIs when integrating new innovative approaches.
3. Collaborate with regulators and other peer organizations.

References:

1. Digital transformation of clinical trials – are we thinking about the patients yet?
   https://www.indegene.com/what-we-think/blogs/digital-transformation-of-clinical-trials-are-we-thinking-about-the-patients-yet
2. DT’s Clinical Trial Digital Tracker, Q1 2022
   https://dt-consulting.com/dts-clinical-trial-digital-tracker-q1-2022/
3. The State Of Customer Experience In The Pharmaceutical Industry, 2022: Clinical Trial Sites
   https://dt-consulting.com/the-state-of-clinical-trial-site-customer-experiences-2022/