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FierceHealthcare – Industry Voices—Harnessing a watershed moment for real-world data

FierceHealthcare – Industry Voices—Harnessing a watershed moment for real-world data

Across every facet of life, 2020 tested our resolve and resilience. COVID-19 stretched our systems to the breaking point, exposing inexcusable gaps and limitations in our systems.

As a force of creative destruction and reinvention, however, it also prompted new conversations, broke through barriers and accelerated the pace of innovation. This has been as much the case in the realm of real-world data (RWD) as it has anywhere. Even as the rollout of COVID-19 vaccines gets underway, it’s clear that many of the trends in RWD that gained prominence in this year of crisis will continue to be dominant forces into 2021 and beyond.

New collaborations in data sharing

The pandemic inspired an all-hands-on-deck mentality, sparking cross-sector collaboration and real-world data sharing in the interest of speeding our understanding of the virus. The seminal example of this is the COVID-19 Evidence Accelerator, an initiative launched in June 2020 by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research, which created a forum for data holders and researchers to pool data and share insights to speed understanding of COVID-19 treatment and response.

As Susan Winckler, chief executive of the Reagan-Udall Foundation, noted, while this diverse data community was brought together to address COVID-19, its approach to collaboration will generate “learnings and understandings that are going to extend far beyond the pandemic.”

An expanded role in clinical trial design

As with in-person care, the pandemic caused significant disruption to clinical trial recruitment and participation, with a reported 80% decrease in new patients entering trials per site in April 2020 compared with the previous year. This led to greater virtualization and increased reliance on RWD to supplement trial-based research.

In some cases, this involved getting participant consent to link trial data with RWD from medical claims, electronic health records, and other sources to gain a more enriched view of treatment and outcomes. In others, it meant turning first, or exclusively, to secondary RWD sources to answer questions that may not require on-site trials.

As Bruno Villetelle, head of data and digital for Novartis, noted in a recent podcast, “RWD can be a complement to typical drug development programs by informing a selection of endpoints and the design and recruitment of studies, which can potentially accelerate timelines, reduce clinical trial costs, and increase the probability of success.” For these and other reasons, we can expect to see RWD play a greater role in clinical trial design in the future.

Heightened demand for observational studies

As writer Elie Dolgin recently observed, by removing the “luxury of time,” COVID-19 placed outsized value on RWD and observational studies that offered the promise of quick-turnaround medical insights. Throughout the pandemic, RWD analyses have played a key role in evaluating clinical trial findings as well as informing a deeper understanding of how various risk factors affect patient outcomes. In one such example, real-world studies of the antiviral drug remdesivir, used to treat COVID-19 patients, indicated that children and pregnant women—two groups originally excluded from the controlled trials—could safely benefit from the drug.

Post-pandemic, the pendulum will certainly swing back toward randomized trial data, but it will never reset to where it was. This past year has yielded enough successful examples, as well as key learnings and cautionary tales, to—as FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., put it—“accelerate how to find the complementarity” between the two approaches going forward.

Getting real about diversity and inclusion

The tragic events of the past year brought heightened awareness to long-standing issues of racial and ethnic diversity and representation in clinical research. The latest high-profile example is the finding that pulse oximeter devices—commonly used during the pandemic to measure oxygen levels in the blood and indicate the need for urgent medical attention—are three times more likely to give misleading results in people with darker skin pigments.

Examples like this have sparked much-needed soul searching and led to concrete measures, such as a new set of FDA guidelines for improving diversity and inclusion in clinical trials, among which is the recommendation to leverage RWD “to promote more efficient recruitment of a diverse population.” RWD offers a valuable approach to assembling racially and ethnically representative data sets as well as a powerful tool to examine, expose and correct inherent biases in past and current research.

The events of the past year have created new urgency around the need to evolve our approaches to collecting and evaluating clinical evidence. When applied in the right way to the right questions, RWD has helped speed the process of drug development and approval while complementing and correcting for limitations inherent in traditional studies. The challenge that lies ahead is to harness the urgency of this moment and continue to build upon the progress we have made.

Mike Doyle joined COTA as president and CEO in October 2018 from QPID Health, where he served as president and CEO from 2012 to 2018. He has spent most of the past three decades as a CEO—much of that time in organizations that operate at the intersection of healthcare analytics and solutions designed to improve insights and patient outcomes while reducing the cost of care.…