Jeff Wiley, head of oncology, global clinical project delivery at Labcorp Drug Development, sheds light on how Labcorp Drug Development is using remote monitoring to advance the industry toward new levels of connectivity.
Clinical trial collaboration between sponsors, CROs, and sites has been difficult because of heavy reliance on manual processes. In particular, the use of email and paper to share information with research sites slows down studies. When COVID-19 hit, it made working together even harder, accelerating the adoption of new strategies and technologies to keep trials afloat. Through these efforts, positive change is happening as the industry shifts to more connected, digital trials.
CROs are at the forefront of clinical research and recognize that effective collaboration is vital to keep up with stricter evidence requirements and growing complexity in studies. In fact, according to a recent study,1 simplifying information sharing is a top priority for CROs to reduce manual processes (78%), speed execution (61%), and improve collaboration (57%).
Labcorp Drug Development is one of the CROs leveraging digital solutions to advance trial operations and collaboration during the pandemic and beyond. A Q&A with Jeff Wiley, head of oncology, global clinical project delivery at Labcorp Drug Development, sheds light on how Labcorp Drug Development, a global leader in nonclinical safety assessment, clinical trial testing, and clinical trials management services, is using remote monitoring to advance the industry toward new levels of connectivity.
Q: How did your journey towards remote monitoring start, and how has it helped during COVID-19?
Wiley: At the start of the pandemic, Labcorp Drug Development had a clinical research associate (CRA) conducting monitoring onsite with an April target for database lock. The sponsor planned to complete the associated clinical study report and make their investigative new drug (IND) submission by December. But while the monitor was on site, we found out that a COVID-19 patient was at the clinic. Our CRA quickly went home, and we faced risks for delay in our timeline.
We had to act quickly and implement an alternative monitoring strategy to ensure study timelines were upheld. Thankfully, we were already working on adding Veeva SiteVault, an eRegulatory system with remote monitoring capabilities, at the research site. Less than two weeks after the incident, we had a system in place and remote source data verification (SDV) was initiated. Four weeks later, all SDV was completed, and the database locked shortly after. By acting swiftly, we experienced no timeline delays and could execute without compromising data integrity or patient safety.
Q: How has the use of remote monitoring evolved at Labcorp Drug Development?
Wiley: When we evaluated all of our monitoring worldwide across various therapeutic areas, we learned that only 10% of our sites were conducting CRA visits remotely before the pandemic. At the height of the pandemic, that number rose to more than 70%. So we see remote monitoring as a key element to improve efficiency in trials, and its use will likely continue to grow.
Q: Why do you think remote monitoring was used so sparingly pre-pandemic?
Wiley: As with most industry changes, the adoption of remote monitoring has been slow because of concerns around patient privacy and access. But COVID-19 accelerated change across the industry, and when we think of the increase in remote monitoring as a small indicator for evolving trends, significant advances are happening that have been a long time coming for life sciences.
Q: What are the challenges of enabling remote monitoring?
Wiley: Incorporating remote monitoring capabilities can be done quickly, but first and foremost, it is essential to gain the sponsor’s agreement. Each organization has different approaches for remote monitoring and SDV, and it can take some time to get buy-in for newer technologies. This is especially true because sponsors need to understand how the solution handles patient privacy and security.
Country regulations relating to remote monitoring and data privacy can also be a barrier to adoption. Labcorp Drug Development decided to create country-specific requirements and evaluated the impact of pandemic-specific guidance issued by regulatory agencies to enable teams to make quick decisions at the project level.
Lastly, sites need to be informed about the systems being used as soon as possible. An eRegulatory system like SiteVault is built specifically for sites, and a CRA only gains access when the site provisions it for a specific study. Alignment with sites is a must for remote monitoring to work.
Q: What advice can you share with companies looking to transition to remote monitoring?
Wiley: With remote monitoring comes an inherent requirement to upload or download records that need to be imported into the eRegulatory system. To avoid misappropriation of time and effort, monitoring strategies should incorporate limited remote source data verification. The strategy should focus on critical data that supports trial endpoints and patient safety.
Often the most time-consuming process we face is working with the sponsor to understand system privacy and security structures, including the appropriate handling of personal health information. Your software provider should have an extensive library of information on their website to assist in this process, and all organizations should take the time to understand these controls.