年度临床试验综述

Phase I–III Clinical Trial Initiations October 2023 The A nnual Clinical T rials R oundup Introduction Last year we remarked on the resilienceand return of clinical trial momentum post-pandemic, where we saw a 6% growth of totaltrials (22% excluding COVID-19 trials) in 2021.1One year later, the roller coaster resumes as thehealthcare industry continues to be influencedby the global economy and political climate. Bigheadline events — the Inflation Reduction Act,the ongoing Russo-Ukrainian war, harsh fundingcuts and divestments in the biopharma sector,and stalled economic growth in China — arejust a few headwinds the healthcare industrybraved in 2022. As the world picks up the paceto rebuild momentum and put the pandemicbehind it, navigating through the evolvingregulatory guidance and market dynamics callsfor endurance and perseverance. disruptions appeared to have slowed down. Ifwe exclude COVID-19 trials from the 2021 mix,trial growth returned a remarkable 22%. In 2022,there are many fewer trials overall; even with theexclusion of COVID-19 trials, trial initiations stillexhibited a decline of 6%. The clinical trial landscape changes a bit if wetake a closer look at industry-sponsored trials,which may better represent the current health ofthe pharmaceutical industry. In 2022, industry-sponsored trials (Table 2) decreased by 7%overall, but if we exclude COVID-19 trials, thisreduces to a 4% decline, reflecting the industry’ssurvival mode since 2021. As with each edition of our Clinical TrialsRoundup, we focus on an overview of the PhaseI–III clinical trials that initiated in the priorcalendar year (2022) across all therapeuticareas comprehensively covered by Trialtrove, aswell as in-depth analyses into the key diseases,players, and geographies that impact thepharmaceutical industry. We will also look at anylingering effect of the pandemic, recovery, andchallenges of adapting to the new equilibrium. As of June 26, 2023, Trialtrove curated 9,104Phase I–III clinical trials (Table 1) investigatingat least one drug and with a disclosed startdate within the calendar year of 2022, returninga decline of 12.5%, breaking the upward trendof clinical trial counts for the first time since2016.2In 2021, we saw a year-on-year (Y-O-Y)growth rate that returned to a more comparablelevel to pre-pandemic years, once the COVID The A nnual Clinical T rials R oundup The data in Table 2 also support a trendingdeparture of COVID-19 trials research byindustry sponsors in 2021 (619 trials) and 2022(344 trials). Companies such as Roche andNovartis have shifted their focus away fromCOVID-19 over the last two years, while Pfizerheld on like a long-distance champion in thisarena. The exclusion of COVID-19 trial count is a way to minimize the COVID effect on thetrials landscape, providing a surrogate healthcheck on clinical research. The decrease intrial numbers in 2022 demonstrated a morerestrained and cautious environment for clinicalresearch, guided by a complex myriad offactors: the global economy, legislation, and theoverall political climate. The A nnual Clinical T rials R oundup Clinical Trial Activity by Therapeutic Area The ranking of therapeutic areas (TAs) by trialinitiations in 2022 remained the same as in prioryears, albeit most TAs saw a modest decreasein trial counts. Infectious disease (ID) had adramatic rise to second place when its trialinitiations rose from 760 trials in 2019 to 3,053trials in 2020, largely contributed by COVID-19trials. While the pandemic persisted through2021, the number of ID trial initiations droppedto 2,771 trials, and further decreased to 1,711(-38%) in 2022, closing the gap of its lead overcentral nervous system (CNS) trials. Oncology (Onc) continued to be the top-ranking TA witha clear lead, even though its trial initiationswere down by 10%. The cardiovascularTA experienced a 15% decrease of trialinitiations in 2022, while other TAs such asmetabolic/endocrinology (Met), autoimmune/inflammation, ophthalmology (Oph), and CNSheld on to their 2021 rebound and saw a smallerreduction between 1% and 3%. Genitourinary(GU) is the only TA with growth, posting a 4%rise in 2022. The A nnual Clinical T rials R oundup Trial Phase Distributions Clinical trial initiations saw a similar trend acrossPhase I–III; Phase I had the most initiations,followed by Phase II and Phase III. There wasan increase in Phase I trials (+4%), which nearlymatched the decrease in Phase II trials (-3%). The proportion of mixed phases (Phase I/II andPhase II/III) and Phase III trials had little to nochange. The current phase distributions reflecta healthy return to new research activities androbust pipelines in development. The A nnual Clinical T rials R oundup Top Diseases for Phase I–III Clinical Trials Each year we analyze the top 10 diseasesfor clinical trial activities to get a glimpse ofwhere research efforts are taking place. Aftera two-year reign, COVID-19 finally gave up itsnumber one spot back to an oncolo