Covid-19 has significantly impacted clinical trials activity around the world.
In fact, at the height of the pandemic, over 1,300 clinical trials were negatively impacted, according to estimates from Berlin University. In addition, several large global Contract Research Organizations (CROs) reported significant impact on their Q1 earnings and activity—in one case reporting that 80% of their global clinical trial sites were inaccessible.
To understand how Covid-19 has impacted clinical trials, we spoke with Peter Payne and Cynthia Senerchia from Optum's Digital Research Network (DRN). DRN helps simplify and automate the clinical trial process. Operating as a single technology platform, the DRN leverages electronic medical record systems used in clinical care to find research-ready patients. This accelerates trial enrollment and captures streaming data. (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.)
Payne and Senerchia highlighted how Covid-19 has created new urgency for disruption and digitization of clinical trials.
Question: How has Covid-19 impacted clinical trials?
Payne: Starting early in the pandemic, many clinical trial sites in the United States closed new patient enrollment. Re-opening has been slow, as health systems cope with severely ill Covid-19 patients, as well as the significant impact of Covid-19 on the risk/benefit equation of participating in a clinical trial, especially in chronic ambulatory diseases.
In response to the pandemic, adoption and implementation of some digitized components of clinical trials has been accelerated. For example, some patients are now able to provide consent remotely via an e-consent application. This has been particularly popular with physicians and patients wishing to avoid visits to health care facilities. Similarly, the use of telemedicine and other forms of virtual visits have been adopted where appropriate.
Other components of trials have become increasingly de-centralized, or conducted outside of a traditional, in-person clinical trial site. For example, some study protocols have been amended to allow nurse visits to the patients' home for administration of study drug (e.g. I.V. infusions), allowing patients to avoid frequent visits to health care facilities.
Q: Has Covid-19 impacted the quality/strength of clinical evidence resulting from clinical trials?
Senerchia: It is probably too early to tell if any of the measures put in place to maintain clinical trial activity during the pandemic will improve evidence generation for life science companies. In fact, in some cases there may be a reduction in data and evidence generation, and life science companies my need to re-evaluate their data analysis approach.
In other cases, studies have had to operate under circumstances more akin to the real world setting than is typical for many highly controlled clinical trials. Evidence from these studies can benefit payers, providers, and other decision-makers who often believe that clinical trial data is not representative of their real-world patient populations.
Q: How is the pandemic highlighting the need for clinical trial innovation?
Payne: Virtual clinical trial platforms have seen an increase in activity during the pandemic, even though the innovation brought to the market by these companies occurred well before the pandemic started. For example, Science 37, a leading decentralized/virtual trial site provider, recently raised $40 million in funding during the pandemic to extend its existing offerings, which include a virtual trial site platform. Similarly, Medable, another leading company in this space, achieved 400% growth in first half 2020.
Life sciences companies are also increasingly using available historical or concurrent real-world data sources to construct virtual control groups or synthetic control arms to reduce the number of participants in clinical trials. Although this use of real-world data is garnering increased attention and acceptance during the pandemic, it has also occurred well before the pandemic.
Q: What are the biggest opportunities for innovating clinical trials during the pandemic?
Senerchia: We see the biggest opportunities for real innovation during the pandemic being incremental, rather than "game-changing." Now more than ever, clinical trials must focus on “putting the patient first,” minimizing the burden patients face if they'd like to participate. So, what does this look like in practice? Get more creative and critical in terms of protocol design, visit schedules, data collection, drug dispensing and administration, etc.
Post-pandemic, there is a significant opportunity to re-think the future of clinical trials and push for digitization and decentralization—both to offer protection against future disruptions to patient enrollment and data collection and improve the trial experience for patients.