This is a second part in a series of Q&A interviews with Optum's Digital Research Network (DRN). Check out our first Q&A with DRN here, or click here to see VirTrial's perspective on clinical trial innovation.
We recently shared the Optum Digital Research Network's (DRN's) perspective on how Covid-19 is reshaping clinical trials. In this blog post, Peter Payne and Cynthia Senerchia from DRN share their thoughts on what the future of the clinical trial landscape may hold.
(Advisory Board is a division of Optum, which is a wholly owned subsidiary of UnitedHealth Group. Optum Digital Research Network is a product provided by Optum.)
Question: What are the opportunities to use virtual and decentralized trials to innovate clinical research?
Peter Payne: Virtual trials use tools and technologies to ease the burden of participation for investigators and patients. They are the perfect way to generate long-term, real-world evidence. For example, new innovations in virtual trials are allowing researchers to pull EHR and other e-sourced data directly into an electronic data capture (EDC) system. This removes the need for site personnel to manually transcribe data between systems, greatly reduces the number of data queries generated, eliminates the need for source data verification, and can be automated. This results in efficient data management for studies, lower-cost long-term evidence generation, and less burden on all participants.
In addition to offering protection against future disruptions to patient enrollment and data collection, decentralization of clinical trials would help address one of the biggest challenges faced in clinical trials in the United States: the lack of participant diversity and inclusion, and the disparity in health care equity. The Multi-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard recently released the "Diversity, Inclusion and Equity in Clinical Research Guidance, Toolkit and Website," which provides all stakeholders with incredibly valuable resources to better understand and address these issues.
Q: What's standing in the way of clinical trial innovation today?
Cynthia Senerchia: The life sciences industry has always prided itself on scientific innovation. However, given the industry's complex regulatory and compliance rules, there is sometimes a reluctance to innovate clinical trials from an operational perspective. Yet, we often see life science companies applying the same rigor to post-approval studies as they do to pre-approval studies. So, life science leaders should have confidence in their historic record of regulatory compliance and recognize that clinical trial innovation can be carried out in a safe, ethical, and compliant manner.
In addition, life science companies, regulators, patient advocacy groups, payers, health care technology companies, and other service providers need to come together to create a set of common standards for de-centralized clinical trials. This happened with the development of common standards for clinical data established by the Clinical Data Interchange Standards Consortium (CDISC) and would benefit the industry greatly.
Q: How will clinical trial innovation improve evidence generation for life science companies?
Payne: By minimizing the number of required in-person patient visits, clinical trial innovation can expand the accessibility of trials to patients in rural communities, rather than keeping the focus only on major academic research centers. It can also help life science companies think critically about what data elements are really necessary to collect during clinical trials. Rather than collecting data "just in case it is needed," they can focus on what elements are essential for all stakeholders.
There is also significant opportunity for life science leaders to invest in using innovative trials to conduct post-launch real-world evidence studies, for purposes other than for regulatory decision making. However, more FDA guidance regarding real-world evidence uses and applications is needed to advance this further.
Q: What is one thing you want other parts of the health care industry to know about clinical trial innovation?
Senerchia: For too long, clinical trials have been disconnected from the care provided by physicians—and sometimes have been seen as detracting from the physician's ability to provide patient care, rather than improving it. When you consider that 54% of clinical investigators participate in one research study and never participate in another, it is clear considerable work needs to be done to ease the burden of participation on clinical sites.
Developing tools and technologies to ease the burden of study participation will increase the pool of potential investigators and potentially improve diversity, inclusion, and equity in clinical research. Thinking of clinical research as a care option should be core to how we think.