The COVID-19 pandemic gave rise to innovation in conducting clinical trials, including decentralized and direct-to-patient services. Will this trend continue, and what may be the impact on clinical trial material supply? DCAT Value Chain Insights examines the issues.

Clinical trials is a post-pandemic environment

One of the key issues for the industry is whether, and to what extent, will virtual and remote clinical trials continue in the future. A report by PwC’s Health Research Institute (1), released in December 2020, examined the top issues in the health industry for 2021 and concluded that the move to remote and virtual clinical trials, adopted during the pandemic out of necessity, is likely to continue. A separate PwC study, conducted in August and September 2020, showed that 38% of bio/pharmaceutical executives surveyed expect that more than a quarter of their clinical trials will be virtual by 2025.

The PwC Health Research Institute study also examined the move to decentralization in clinical trials through the use of nontraditional physical locations such as in-store health clinics, which are closer to patients’ homes (1). The report pointed to the formation of a new industry group, the Decentralized Trials & Research Alliance (DTRA), which was launched in December 2020, to advance the global adoption of decentralized clinical research. DTRA is composed of more than 100 stakeholder organizations that include bio/pharma companies, life-sciences research groups, patient advocacy organizations, and other other organizations. Its members include Amgen, Astellas, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson’s Janssen, Pfizer, Roche, Sanofi, and Takeda as well as contract research organizations, such as Covance, information technology/data providers, such as Oracle and Verily, the life-sciences arm of Alphabet Inc., Google’s parent company, as well as the US Food and Drug Administration.

”The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate”, said Amir Kalali, M.D., life science executive, founder of several collaborative life-science communities, and co-convenor of DTRA, when launching DTRA in December (December 2020). “The COVID-19 pandemic has forced organizations to adopt decentralized methodologies which have the potential to broadly accelerate drug development.”

In May (May 2021), DRTA outlined four priority areas in realizing its goal of decentralized research: (1) establish common nomenclature & definitions, archetypes, and key performance indicators around the practice of decentralized research; (2) identify and promote best practices in decentralized research; (3) prioritize education by building a knowledge repository and mechanisms for information sharing; and (4) identify and remove barriers to decentralized research implementation, establishing roadmaps to their resolution.

While each priority area has several associated initiatives, the DTRA has prioritized specific goals in the immediate term as outlined below. 

Decentralized Research Glossary. One objective is to create a comprehensive Decentralized Research Glossary that is easily accessible to relevant stakeholders to establish common nomenclature and definitions, including defining archetypes of decentralized trials.

Best Practice Repository. A second goal is to establish a collaborative Best Practices Repository with dynamic updates of trusted resources for study teams to identify where existing pathways exist for areas perceived as challenges as barriers.

Data and Knowledge Repository. A third goal is to compile a Data and Knowledge Repository with evidence of the impact of decentralized research capable of supporting education, research, and awareness.

Central Library. The fourth goal is to build a central library of global regulatory, legal, privacy, and culture information that contains dynamic links to relevant regulatory sites to assist in the removal of barriers to entry.

Last September (September 2020), another industry group, the  Association of Clinical Research Organizations, issued a white paper and toolkit to provide a set of operational best practices for the implementation of decentralized clinical trials to facilitate sponsors and research organizations.

Challenges and opportunities

While remote/virtual and decentralized approaches to clinical trials opens up new opportunities, the PwC Health Research Institute report also outlines some key issues to consider. It points out that not every therapeutic area is appropriate for decentralized studies or for remote interactions. Moreover, the report points out that the cost-benefit of applying remote tools for patient interactions and monitoring may create savings in onsite monitoring and management, but may also involve additional costs, such as providing participants with monitoring devices or wearables.

Resources and workload are other considerations in moving to virtual/remote trials. A recent article (2) by Kenneth Getz, Director and Research Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, provided results from a recent study from the Tufts Center for the Study of Drug Development (Tufts CSDD) that examined how clinical development may proceed in a post-pandemic environment and what practices developed in response to the pandemic may continue forward.

The study was based on a collection of interviews with principal investigators and senior study coordinators from clinical trial sites and site networks globally to gain feedback on the transition to virtual and remote clinical trials (2). The study found that although virtual and remote clinical trials increased choice and accessibility for patients, they greatly increased workload for site personnel. The study also found that site professionals reported delays starting up studies, receiving clinical trial supplies, and lab kits (2).

References

1. PwC Health Research Institute, Global Top Health Industry Issues 2021: Innovation Fueled by Digital Capabilities, December 2020.

2. K. Getz, “Contemplating the Full Measure of Pandemic Response,” Applied Clinical Trials Volume 30, Issue 6, June 2021.