Modernizing R&D: A Primer On Decentralized Clinical Trials

THE COWEN INSIGHT

The clinical research industry is undergoing an evolution that aims to improve access to clinical research, speed enrollment timelines, and make studies more efficient and robust. Embedded in this shift is the decentralized clinical trial model that relies on hybrid or remote study sites, underpinned by new and established clinical research organizations and tech companies.

Decentralized trial providers and healthcare tech cost is uniquely poised to benefit from this shift offering new tools to improve access and deliver robust results. With regulatory support and growing biopharma adoption, decentralized clinical trial providers and tech enablers should capture 33.1% of total R&D spend by 2030.

OVERVIEW OF THE CLINCAL TRIAL OPERATIONS LANDSCAPE

This multi-analyst report provides a wide perspective on the shifting clinical trial operations landscape. It includes the perspective of large biopharma customers using or likely to use these tools in the future, traditional clinical research organizations (CROs) that are often tasked with executing and managing clinical operations, and the regulatory landscape.

In addition, it is supported by six KOL interviews spanning the decentralized clinical trial customer base and regulatory perspective, our proprietary Cowen Biopharma R&D Leader Survey of 50 biopharma R&D department leaders, as well as proprietary research on the growing size of the clinical trial operations market and TAM analysis. It also includes relevant takeaways from our May 2022 survey of 89 biotech, pharma, and MedTech companies, gauging their use of decentralized trials as a means to improve clinical trial diversity and representation.

THE GROWING PREVALENCE OF DECENTRALIZED TRIALS

The clinical trials enterprise is undergoing a shift with the entrance of key enabling technology and tools providers that could allow biopharma companies to get products to patients more efficiently through robust, representative, and more broadly accessible studies. Primary to our thesis is the growing prevalence of decentralized trials that offer the potential to move away from traditional brick-and-mortar study sites. This has the potential to make clinical trials more efficient and more attractive to a broader swath of individuals.

SHIFTING CLICNICAL TRIAL PRACTICES

Biopharma companies are often hesitant to stray from traditional practices, with the burden of proving clinical benefit for a new therapy already considered a significant risk. Thus, a dramatic shift in the very manner in which they conduct clinical studies to show benefit would seem unlikely.

However, the COVID-19 pandemic spurred quick adoption of decentralized trials and remote clinical trial tools out of necessity for business continuity. It essentially forced companies to try decentralized clinical trials. Given this, many biopharmas have already gained early experience with decentralized clinical trials. Thus, we believe we are at an inflection point on the adoption curve. While the extent to which DCTs are adopted is likely to oscillate over the next three to five years, our virtual roundtable of experts and proprietary research finds that the industry is not going back to business as usual.

ADDITIONAL DRIVERS FOR ADOPTION

Other drivers of decentralized clinical trial adoption include the increased focus by biopharma to make studies more representative. We find nearly one-third of our covered companies relying on decentralized clinical trials to improve trial diversity. They are also used to improve trial efficiencies and get medical products to patients faster.

Together, these drivers support continued adoption and expansion into the future for these platforms. Our KOL checks also find that regulatory support for decentralized clinical trials and enabling tools will only increase as the agencies seek more ways to modernize and expand patient access to clinical trials.

EVOLUTION OF CLINICAL TRIAL OPERATIONS

We forecast an evolution – not a revolution – of clinical trial operations through integration into the standard drug development paradigm. This report, underpinned by proprietary research, along with our fifty-person Cowen Biopharma R&D Leader Survey, and a six-person virtual KOL panel, outlines the evolution of the clinical trials enterprise and the companies we view as uniquely poised to capitalize on this shift.