Traditional clinical trial models place limitations on patients, with logistical and geographic barriers making it difficult to recruit, enroll, and retain a diverse participant pool. Decentralized clinical trials bring the study to the patient, in some cases virtually, reducing timelines, increasing patient engagement, and optimizing efficiency with new technology.
We recently sat down with Dr. Bola Oyegunwa, Vice President and Head of Virtual Trials at Covance. Bola is an industry thought leader in developing and implementing virtual trial solutions. As a follow up to the highly attended webinar, Decentralized Trials Are on the Rise: What You Need to Know, Bola answers audience questions he and Mike Novotny, our founder and CEO, were unable to address during the live presentation. He shares his direct experience in implementing decentralized trials and provides guidance on how to get started.
Eligibility and enrollment in decentralized clinical trials
How do organizations handle eligibility in DCT implementation? Are there are no study sites?
Investigators stay involved in eligibility decisions by reviewing medical records and the patient’s medical history. PIs maintain full responsibility for the eligibility process but can conduct oversight virtually with remote patient participation.
To what extent are primary care clinicians involved in DCTs? What can be the roles and responsibilities of general practitioners in this type of trial?
The PCP or GP can support standard of care activities, including physical examinations, vital signs measurement, and comprehensive patient work-ups. They will share collected data with the PI to ensure study oversight.
How will the drug or vaccine get to the participant or patients in a decentralized trial? How does the sponsor or site set up nurses to visit the home? Are there any restrictions?
Depending on many factors, the drug will be shipped to the patient directly (this is currently happening in numerous studies). There are existing processes to ensure that the drug reaches the right subject within the required temperature range. There are third-party organizations that partner with sites to provide home health nursing and phlebotomist solutions. Regulatory restrictions may apply by region.
If patients never or rarely see the PI, how do you ensure appropriate PI oversight? How can you ensure robust safety reporting processes?
Patients will have routine televisits with PIs. Depending on the study design, some visits may take place at the investigator site. The PI will have oversight of all patients, similar to site-based studies.
Evidence and support for DCTs
What type of studies have you seen implement decentralized clinical trials most successfully?
We’ve seen a lot of success with long-term follow-up studies. Additionally, we’ve seen positive results with studies that involve a lot of specimen collection and routine lab testing.
Can you share the research that shows the benefits of decentralized trials and any regulatory guidance in support of DCTs?
The FDA has publically stated support for hybrid and virtual trial delivery modalities. They have committed to providing a guidance document on this topic. European regulators have also indicated acceptance of this approach.
How can organizations use this framework in commercial efforts after FDA approval (i.e., payer and provider engagement)?
The framework supports post-marketing studies and safety follow-up studies post-commercialization.
Are decentralized trials a global trend? Did they originate in a specific region or area of research?
Recently, DCTs have become a global trend. Both industry and regulatory consortiums in North America, APAC, Europe, and Australia are exploring the best implementation approach.