By Laura Runkel, PhD, Associate Director, Citeline
As the COVID-19 pandemic stretched through a second year, its impacts continued to reshape the clinical trials landscape. Trialtrove recorded 4,109 industry-sponsored clinical trials from Phase I through to Phase III/IV that either reached completed status or reported primary endpoints during 2021.1 This number exceeds the tally of 3,777 in 2020 and represents an 8.8% annual increase, which is double the growth rates observed in the pre-pandemic period from 2017 through 2019 (3.0–4.3%). An additional 838 studies reported terminations in 2021, which is a 21% decrease compared with those reporting termination in 2020 (1,067). Both of these directional changes point towards the early signs of a recovery from the disruption caused to ongoing clinical trials in 2020.
The Oncology, Infectious Diseases, and Vaccines therapeutic areas all saw substantial growth, while the remainder either grew modestly (Autoimmune/Inflammation, Central Nervous System, Ophthalmology) or decreased their trial completions (Metabolic/Endocrinology, Cardiovascular, Genitourinary). A massive increase in COVID-19 trial completions was the major driver to overall trends and the observed 8.8% topline growth. However, this disease area also was uniquely impacted by high trial terminations, due to challenges in recruitment and logistical factors.
Despite the turbulence caused by COVID-19, the leading clinical trial sponsors achieved success rates comparable to those in 2019 in trials conducted across a wide array of rare and prevalent diseases. This top 20 group of companies continues to focus on global trials, although the increased domestic trial activity by Chinese sponsors is now making a mark on overall completed trial trends. Within the top three therapeutic areas of Oncology, Infectious Diseases, and Autoimmune/Inflammation, the current trends and major players are further explored in this white paper.