By Mohammed Ali, Chief Domain Officer

As 2022 rounds the bend, the life science industry is at a critical juncture in the adoption of the decentralized clinical trial (DCT) model. Recent insights from the study published by the Tufts Center for the Study of Drug Development shows that decentralized trials can achieve net financial benefits ranging from five to 13 times for Phase II and III trials, equating to roughly a $10 million ROI and a $39 million ROI, respectively. In addition, a record 1,300 trials with a decentralized component began at the beginning of the year, representing a near-30% increase from 2021.

With such unprecedented adoption, we have also learned a lot. At the core of this learning, we understand how clinical research sites have largely unified on their view of the challenges and areas for improvement. Best practices and new software platforms have led to an increase in the training and technology management requirements thrust onto their already emaciated staff – turnover rates for clinical research professionals hover around 30%. The Society of Clinical Research Sites “2021 Landscape Report'' revealed that technology is adding an average of 17.5 hours in training per study per site per month. And, even though add-on training requirements are not new to the research ecosystem, it must be addressed.

We are at a crossroads – something that was made increasingly clear by a new Association of Clinical Research Professionals (ACRP) think tank where I participated. The think tank included 42 participants from various stakeholder groups, including sites, CROs, academic research organizations, healthcare providers, pharmaceutical companies, and regulators. We found that the leading barrier to adopting DCTs is the lack of clarity around regulatory requirements. Other barriers include a lack of budget flexibility and challenges managing third-party vendors. (See the special report here). Surprisingly, this thinking contrasts with widespread beliefs that technology is the primary barrier to adoption of decentralized trials.

Sites Report Technology is NOT the Top DCT Barrier

It appears the life sciences industry has made too many assumptions around DCT adoption and sites. If we are to continue making progress in DCT adoption, we must proactively listen to sites and stop getting in our own way.

“DCT approaches rely on principal investigators and study teams being able to incorporate decentralized approaches without impacting safety or quality,” said Susan Landis, ACRP Executive Director, in today’s announcement. “Therefore, the clinical research industry must consider the real-world experience of clinical research professionals at the site level for DCTs to be successful.”

As we move into the New Year, Medable is prioritizing productive partnerships with sites to hear what their biggest frustrations are and ways to overcome these for broader DCT adoption. Specifically, we will work with our site partners to enhance our product offerings and to map out a proposal for new health authority regulations that would do more to enable decentralized trials at sites. The group will also begin developing guidelines for global harmonization of DCTs within regulatory guidelines.

We already see early interest in joining our mission. In October, Medable posted an open link on LinkedIn inviting clinical research sites to provide input to us on DCT workflow and integrations and more than 20 members of different site organizations signing up to share their real-life experience and offer insights. In 2021, Medable first launched its Site Network Council whose members help ensure Medable products meet the needs of all site stakeholders. They review training, workflows, and user interfaces and provide insights on study approaches prior to study launch to ensure maximum site value.

Drug development is part of a complex ecosystem. Consequently, implementing any major innovation industry wide will take time and creative execution to perfect. Open dialogue and ongoing feedback are crucial to ensuring the innovation reaches its potential.  Medable knows that innovation is never static. We support all of our partners in achieving success even as dynamics shift.

DCTs hold great promise but to maximize their benefits, the industry must identify its pain points for all stakeholders, especially sites that are on the front lines of research. Sites are the cornerstone of research and I don’t expect this will change. At Medable, we aim to partner with these important organizations to drive lasting change.

To join our site working group and provide input on our DCT product, please contact me at mohammad.ali@medable.com.

‍