The Annual Clinical Trials Round-up 2021

By Heidi Chen, PhD, Associate Director, Research & Commercial Support, Principal Analyst, CNS, Autoimmune/Inflammation & Ophthalmology

We saw an explosion of trials initiated in infectious disease, while clinical trials in other therapeutic areas endured setbacks in their enrollment and trial progression. With the uptake of vaccinations from late 2020 through 2021, and the rollercoasters of variants that dashed hopes of returns to normalcy, the entire healthcare industry is learning to coexist with COVID-19. As the industry continues to navigate new ground in this ever-changing climate, we will assess trends across Phase I–III clinical trials initiated in the year 2021, and see if the stories within the data can help us determine whether we have reached a “new normal” in this post pandemic world. Certainly, recent experience has shown newfound resilience within the clinical trial ecosystem, through adaptive initiatives and trial design shifts that not only facilitated response to the pandemic, but also brought clinical trial innovations to the spotlight.²

This year’s Clinical Trials Roundup is focused on an overview of the Phase I–III clinical trials that initiated in 2021 across all therapeutic areas (TAs) comprehensively covered by Trialtrove, as well as in-depth analyses into the key diseases, players, and geographies that impact the pharmaceutical industry post-pandemic. We will compare the trial activity landscapes with those of 2020 and 2019, to account for any insightful trends resulting from the pre- and post-COVID-19 era.

As of 23 June 2022, Trialtrove captured 10,410 Phase I–III clinical trials investigating at least one drug and with a disclosed start date within the calendar year of 2021, returning the year-on-year growth closer to prepandemic years at 6% (Table 1). In 2020, the unusual 26% increase in trial initiations was inflated by studies investigating treatment and prophylactic interventions for COVID-19, although year-on-year growth excluding COVID-19 trials saw a modest dip. With the deployment of COVID-19 vaccines, trial activity in 2021 reflected a shift in focus towards normality, with non COVID trials returning strongly with a 22% growth.

Clearly, a bolus of trial demand had built up during 2020, with deployment deferred until the wider healthcare situation was more stable. The significant growth in 2021 trials also results from the benefits of modernization and innovative approaches used in response to the pandemic, such as decentralized trials, innovative recruitment strategies, and greater patient engagement.