Our Take

How are sources and uses of medical evidence evolving in 2021?

Across the last year, Advisory Board has been tracking key trends across the health care ecosystem to understand their impact on sources and uses of medical evidence. In the below article, we outline two key things medical leaders need to know.

The pandemic could be a catalyst for broader acceptance of RWE, but medical leaders must take advantage of the opportunity to evangelize RWE for use cases beyond Covid-19.

Medical leaders have long dealt with skepticism around real-world evidence— both from their customers and even from peers in other functional divisions. Despite a growing body of evidence that RWE can provide meaningful insights about efficacy and value, much of the health care industry still views randomized controlled trials (RCTs) as the “gold standard” for evidence.

Covid-19 could be the catalyst to change that assumption. The pressure to diagnose, track, treat, and vaccinate large populations in order to end the pandemic has led many stakeholders to recognize the value of evidence generated outside of an RCT. Throughout the Covid-19 crisis, HCPs relied on early-stage clinical data and anecdotal evidence to inform complex treatment decisions and decide which patients to enroll in clinical trials. Progressive payers and providers created symptom trackers and diagnostic tools to collect RWE about their populations, understand symptom progression, detect at-risk individuals, and direct those individuals to Covid-19 testing sites. Even leaders from FDA—which relied on RWE to support emergency use authorizations and accelerated approval timelines—have stated that FDA plans on using RWE in more non-Covid-19 related product decisions in the future.

Of course, the circumstances of a global pandemic are unique, and payer/ provider willingness to accept RWE so openly may not last beyond it. But medical leaders can still capitalize on the opportunity to demonstrate the value of RWE for specific use cases by leveraging Covid-19 as a case study. For example, RWE is particularly useful in clinical trial recruitment, understanding appropriate use in real-world scenarios, and accelerating regulatory approvals in areas of high unmet need—all areas where Covid-19 served as a compelling test case.

The decentralization of clinical trials is creating an opportunity for trial design, data collection and endpoint selection to be more patient-centric.

One unintended consequence of the Covid-19 pandemic was a rapid uptick in adoption of innovative clinical trial designs, including the use of decentralized and virtual trials. The success of these trial designs has sparked renewed industry-wide interest in figuring out how to make clinical trials more patient-centric—in terms of overall trial design, data collection mechanisms, and the selection of specific endpoints.

To make clinical trials less burdensome for patients and caregivers, trial leaders will likely rely on telehealth, remote monitoring, and direct-to-patient drug shipping. These innovations will not only reduce time-consuming activities that typically disincentivize participation (e.g. transportation to AMCs, frequent check-ins and lab tests,) but could also help diversify the participant pool by expanding manufacturers’ reach to include populations that are traditionally underrepresented in clinical trials.

Decentralization also creates opportunities for more patient-centered data collection techniques. This might involve using wearable devices to facilitate long-term outcome tracking and generate longitudinal data sets. It could also include collecting patient-reported outcomes from websites or apps, or experimenting with digital endpoints that patients collect using their smartphone cameras and sensors. In turn, these expanded (largely remote) data collection platforms may enable broader incorporation of patientcentered endpoints—including harder-to-quantify metrics like symptom improvement, fatigue levels, or ease of performing acts of daily life.

While many of these innovations are nascent, they have the potential to meaningfully impact how life sciences companies develop new treatments and build their value narratives. Progressive medical leaders should evaluate how these changes could be incorporated into their evidence generation strategies— both for pre-launch as well as post-launch and longer-term RWE studies.

About Advisory Board

For more than 40 years, we've helped executives and future leaders in health care work smarter and faster by providing provocative insights, actionable strategies, and practical tools to support execution.

With 40+ years of experience, a team of 250+ experts, and a network of 4,900+ member organizations that span the payer, provider, and supplier industries, we support life sciences firms’ commercial and medical leaders with research and educational resources that develop market strategy, enrich customer insight, and more.

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