The Health Pulse S2E2: The Next Evolution of Decentralized Clinical Trials

The Health Pulse

On this episode, Greg Horne interviews Craig Lipset, advisor, advocate and educator in the area of decentralized clinical trials and the former head of clinical innovation at Pfizer. During his time at Pfizer, Craig helped design and lead the first fully remote, decentralized trial. Surprisingly, that was more than a decade ago. In fact, Craig explains that the methods, investment and even the regulatory readiness around decentralized trials existed in the industry long before the pandemic. The lock-down disruption caused by COVID-19 in early 2020 delivered a key missing piece – meaningful adoption as the industry worked quickly to mitigate delays to ongoing research and spin up new trials to address the virus.

Craig and Greg further discuss the potential for decentralized trials to make participation in clinical research more convenient and accessible to diverse and representative patient populations. Unique support is required to achieve this objective. Decentralized trial participants need specialized technical and emotional support to ensure they have a positive experience and are able to stay compliant with study protocols. In developing nations, decentralized methods can help researchers expand their work into areas where infrastructure may be lacking, but it’s critical to be mindful of the digital divide and ensure that the appropriate support is provided.

Craig leaves us with his perspective on the role of decentralized trials in helping health care deliver clinical research as a care option. For example, the technology offers new ways to engage with non-investigator physicians to improve engagement with community health care and democratize access to clinical research.

A transcript of this episode can be found here.

All presentations represent the opinions of the presenter and do not represent the position or the opinion of SAS.