08 June 2022 | News
4,109 industry-sponsored clinical trials have moved from Phase I through to Phase III/IV and have either reached completed trial status or reported primary endpoints during 2021
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Pharma Intelligence has recently published the 2021 Completed Trials report, indicating apparent green shoots of COVID-19 recovery in clinical trials across the pharmaceutical industry.
The report mentions that 4,109 industry-sponsored clinical trials have moved from Phase I through to Phase III/IV and have either reached completed trial status or reported primary endpoints during 2021. This exceeds the 3,777 trials in 2020 and represents an 8.8% annual increase, and doubles the growth rate observed in the pre-pandemic period from 2017 through 2019 (3–4.3 per cent).
Despite the turbulence caused by the pandemic, 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, where the top three therapeutic areas are oncology, infectious diseases, and autoimmune/inflammation. These companies continue to focus on global trials, although the increased domestic trial activity by Chinese sponsors is now making a mark on overall completed trial trends.
The report further indicates that oncology continued to be at the top spot among rankings of therapeutic areas for completed trial activity in 2021. For the first time, Infectious Diseases (ID) shot from fifth into second place owing to considerable COVID-19 pandemic-related trial activity.
The Autoimmune/ Inflammation (A/I) attained the third rank, while Central Nervous System (CNS) and Metabolic/ Endocrinology (Met/Endo) dropped into fourth and fifth places, respectively. Cardiovascular (CV) has been seen to decline in completed trials observed since 2018. Vaccines, which often overlap with ID trials, retained their seventh position while completing substantially more trials in the past year. The smallest therapeutic areas, Ophthalmology and Genitourinary (GU) are trending in opposite directions with modest changes in their trial counts.
Even as notable increases in completed trials were observed in infectious diseases (49.7 per cent), vaccines (47.1 per cent), and Oncology (8.3 per cent), both Infectious Diseases and Vaccines also reported the highest termination rates, with year-on-year changes of 42 per cent and 111 per cent, respectively. It should be noted that despite this high percentage change in Vaccines, the absolute numbers remain low with only 19 trials terminated, compared with nine in 2020, these trials also are classified in the Infectious Disease therapeutic areas as COVID-19 studies.
In autoimmune/inflammation therapy, trial completions increased by 5.3 per cent while terminations decreased modestly (-2 per cent; 137 versus 140). Terminations also decreased, year-over-year, for metabolic/endocrinology (-53 per cent; 57 versus 122), cardiovascular (-54 per cent; 39 versus 85), and Central Nervous System (-34 per cent; 89 versus 134).
The 2021 counts were also augmented by increased activity captured from Chinese registries. These trials are generally run exclusively in China. Most of these trials, ranging from 67.5 per cent to 82.1 per cent for mid-sized therapeutic areas and 55 per cent for oncology, are Phase I or Phase I/II studies, a factor that accounts for most of the growth in that phase observed during this period.
Substantially, fewer diseases achieved at least 25 successful trials in 2021 (14) compared with 2020 (21) and 2019 (17).