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The Tufts CSDD Roundtable took place in November, and on behalf of Veristat, I was honored to participate in this invite-only program. It is part of our company’s DNA to stay ahead of the driving forces in the industry so that we can best serve as a knowledgeable partner for our clients, most of whom are small to mid size organizations involved in rare diseases and novel therapies. Ken Getz, the Tufts CSDD team, my pharmaceutical and CRO colleagues and I came prepared to engage in a frank and open dialogue on quantifying the value proposition of decentralized clinical trial (DCT) deployments.
The goals of the roundtable were to:
Following are my key takeaways from the roundtable discussion.
In principal, DCTs are defined as studies executed through telemedicine and mobile/local healthcare providers, using processes and technology differing from the traditional clinical trial model.1 In practice, a DCT can mean something different to each of us. Those of us participation in the roundtable came to collective agreement that, at their core, DCTs deliver the technology and process improvements in such a way so as to make a trial more accessible and convenient for patients. To make this happen, how then do we, as DCT champions, continue to improve trial design and operationalize the trial so that each study is fully focused on what is important to patients and encourage their ongoing participation.
The challenges that rose to the top in terms of those hurdles most pronounced included:
The challenges outlined by roundtable attendees subsequently drove our thought process to arrive at the following must-haves as we support a sponsor's ability to weigh the benefits of DCT adoption:
The roundtable participants agreed that, overall, the experiences over the past few years have shed light on the ways in which decentralized solutions can support or augment clinical trials. The time as come to better define how we measure their deployment success.
Together we arrived at a DCT KPI wish list:
Quantitative metrics:
Qualitative metrics:
We acknowledged the work ahead as DCT's KPIs are finalized and brought to the forefront. Complicating matters further, the headwinds we face are significant, and include:
Further discussion pointed to the need to integrate study demographic data in order to holistically and realistically evaluate DCT's impact. From my perspective, I shared that enrollment data will be influenced by such demographic data as the sites selected, the therapeutic area, patient recruitment activities (e.g., social media, patient advocacy groups, TV spots, etc.), and such. This broader context will be critical to the small-mid-size biotechs as the demographic study profile of a rare disease trial with a narrow patient population is vastly different from a trial being conducted by a large Pharma for a drug involving thousands of patents.
As we progress forward on quantifying the value proposition of DCT deployments, having Tufts CSDD take the helm on this important endeavor as an independent, non-biased authority and visionary in this space will no doubt serve the needs of patients and our global clinical research community exceptionally well.
While our clients at Veristat are sensitive to the costs associated with deploying DCTs, there is an underlying enthusiasm for the many aspects of DCTs that uniquely address the needs of patients, the study, and the sites.
DCTs should not be a separate standalone consideration. Their evaluation requires that sponsors take into consideration not only the technologies being deployed, but also the people and the processes being impacted. At Veristat, we have uniquely combined our full-service offering with our DCT solutions to work synergistically in order to have a positive impact on patient centricity, site engagement and data optimization.
Veristat has successfully implemented a number of DCT solutions across several studies. In a recent clinical trial involving pediatric patients for Canavan disease, for example, DCT integrations helped our sponsor far exceed their enrollment targets.
We suggest to sponsors that they consider a walk-before-they run approach to DCT deployment. With e-consent, for example, this aspect of the study can be implemented with a relatively low upfront investment. Through its use, we are seeing e-consent deliver a solid return on efficiency.
Undoubtedly, DCTs are evolving and we will continue to see increased adoption, but in a thoughtful way. As we do, Veristat is ready to help our clients optimize their value in order to bring novel therapies to patients faster and more effectively.
1 - Clinical Trial Transformation Initiative, CTTI Recommendations: Decentralized Clinical Trials 2 (2018), available here
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