Last week our CEO Dr. Michelle Longmire sat down with Moe Alsumidaie from Applied Clinical Trials for an interview where they discussed how decentralized clinical trial (DCT) methodologies will transform how clinical trials are executed for years to come. You can read the full interview here on Applied Clinical Trials.
In the interview Mr. Alsumidaie and Dr. Longmire discuss several important insights and considerations including:
- An overview of the current DCT landscape
- How COVID-19 has impacted DCT’s
- Keys to ensure a DCT is successful
- Results from DCT implementations
- How clinical trials will evolve in the future
During the interview, Dr. Longmire highlighted how DCT’s tackle four core challenges that clinical trials have historically faced:
“The first is patient access. Virtual screening and remote eConsent can dramatically improve access to clinical trials. We’re seeing that these decentralized processes consistently enhance patient recruitment, and we’re developing a baseline dataset for comparison.”
“The second challenge DCTs help overcome is patient retention. Compared to traditional methods, we see significant improvements when we’re able to reduce site visits that are more focused on basics such as screening, enrollment, consent, and non-invasive evidence and data capture.”
“DCTs also help overcome issues with data quality, as you mentioned. At a minimum, we want to be meeting the standard for data quality. And in many settings and across various therapeutic areas, we can do that remotely. At Medable, we are starting to think about digital endpoints as a complement to traditional scales and measures. DCTs help with the development of new digital endpoints that are of the same, or better, quality than conventional endpoints. Digital endpoints also provide the opportunity to dial into more disease-based measures for diagnosis and severity.”
“The fourth main challenge DCTs tackle is efficiency. Traditional clinical trials take much time and come with very discrete processes, as different teams generally do recruitment and consent and evidence generation with diverse strategies and varying technologies. In contrast, we provide a process solution versus a point solution with one interface that drives streamlined workflows and provides seamless decentralized capabilities. This improves overall trial execution efficiency.”
At Medable we are continuing to develop new offerings to address these challenges in a modular and flexible way. Our Decentralized Trial Readiness Framework makes it easy to right size your onramp to a DCT for either an in-flight study or a new one.
During the interview, Dr. Longmire also touched on the importance of shifting physical consents and re-consents to a decentralized approach utilizing technologies to enable the Investigator & patient relationship to be replicated remotely :
“Consent is another ideal opportunity for decentralization, which also improves the patient experience. There’s a lot that can be managed remotely, and some actions that are better handled in person – like an invasive procedure. There is a push for some of those activities to be conducted in the home, but as a physician myself, I still see great benefit to having the full suite of access that a hospital affords.”
This week we introduced Medable TeleConsent, a new offering that makes fully remote informed consents and re-consents a reality for both patients and investigators. Doing so will potentially save thousands of hours of investigators and patients meeting physically and reducing their exposure risk during the COVID-19 pandemic. To learn more about Medable TeleConsent, sign up for our DCT Panel Webcast featuring Medable’s Ali Holland and Rasmus Hogreff along with Craig Lipset from Clinical Innovation Partners on Oct 6.