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.

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.

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