Decentralized Clinical Trials (DCT) Monthly Blog – December 2020

Welcome to the December edition of the DCT blog. In our final edition for 2020, we look back on an eventful year.

As we entered into the year, we had a plan for building on prior successes in patient-centric trial design. We had plans for client outreach and events to connect with stakeholders across the industry to continue the incremental task of moving beyond site-based traditional trial designs. We had plans to demonstrate that decentralized trials could become mainstream for drug development, while minimizing risk.

All of this changed, tentatively at first, then decisively and with lasting impact as travel restrictions were enacted. Offices switched to remote working arrangements; the need to avoid unnecessary contact with people became the order of the day. Each of us reacted individually as our worlds were impacted in unique ways, but the common theme we heard both internally and across our clients was a greater concern for the patients: how could they continue to participate? How could they keep getting the care they need?

And so, we took a new approach. Suddenly, switching away from site-based visits and methodologies was no longer perceived as a risk to be minimized. It became a fundamental requirement for trials to continue. We partnered with sponsors to create new, more resilient trial designs and where possible adjusted ongoing trials with services that would enable trial continuity. All of these changes were made with patients in mind.

Along the way, we listened to patients. Our Patient Intelligence system enables us to collect feedback from trial patients, offering a unique insight into their dynamic needs and interests, based on therapeutic area, location and other parameters. Combining this with the trial-specific input we receive from our sponsors, we were able to accelerate the transition of what “normal” means, pivoting from site-centric designs to one where the DCT suite of services can be applied as needed, forming a whole spectrum of solutions. Understanding the urgency of enabling mobile clinical service such as nursing, phlebotomy, drug administration and clinical assessment, we acquired GlobalCare Clinical Trials LLC, to provide in-house access to these services under one contract. Meanwhile we listened to feedback about the need for highly integrative platform solutions that could be configured quickly to save time between a trial’s kick-off meeting and first-patient-in milestones. Our acquisition of snapIoT, a leader in mobile eClinical solutions, gave us a nimble solution to meet this need, saving up to four weeks in trial startup. By bringing these into our enterprise, we are able to craft seamless solutions that incorporate more services, reducing the burden of vendor management while at the same time offering solutions that reduce patient burdens, streamline execution and enhance operational efficiencies.

As we close the year, we look at an industry transformed by unprecedented challenge, but by any measure more fit for the future. The vision of patient-centric trial design is no longer widely perceived as a risky or cutting edge innovation. Rather, it is the new normal that will carry us into the future. We will be continuing this transformation in 2021, with inputs from sponsors, sites and patients, to build on what we have learned so far. It’s safe to say that we have big plans… but we are ready to adapt as needed!

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