2024年度临床试验综述：有希望的康复之路

2024 Edition: Promising Road to Recovery October 2024 The A nnual Clinical T rials R oundup Introduction: Total Trial Activities Welcome to the 2024 edition of Clinical TrialsRoundup. Last year, we unveiled a landscapeof increasing complexity, culminating in anunprecedented decline of clinical trial initiations.The biopharma industry weathered post-pandemic adjustments, endured economichardships and slowed growth in major markets,met regulatory pressures to incorporatediversity, equity, and inclusion (DE&I), andsuffered the impacts of geopolitical conflicts.Last year, we concluded with a cautiouslyoptimistic outlook, anticipating the industry’simminent breakthrough in clinical trialinnovation. trials reflected the industry’s agility to adaptand manage the challenges brought by thepandemic. The 9.4% increase in 2023 is anotable achievement, surpassing the averagetotal growth of 7.8% seen during 2017–23. Over the last three editions of Clinical TrialsRoundup, we have surveyed trial initiations withand without COVID trials to get a sense of howthe pandemic impacted trial initiations in otherTAs, namely the “COVID effect.” The declinein 2020 (-4%) made sense, while 2021 enjoyeda surprising comeback at +22%. Then, trialinitiations dipped back down to -6% in 2022,due in part to the harsh economic environmentin biopharma. The yo-yo has swung back up in2023, exhibiting 13% growth excluding COVID-19trials, also a cut above the average growthrate of 7% for non-COVID trials during 2017–23.Will the oscillating cycles between growth anddecline continue, or is the biopharma industryon track to full recovery? Continuing with our annual tradition of ClinicalTrials Roundup review, the 2024 analysisfocuses on an overview of the Phase I–IIIclinical trials that initiated in the prior calendaryear (2023) across all therapeutic areas (TAs)comprehensively covered by Trialtrove, as wellas in-depth analyses into the key diseases,sponsoring companies, and geographies thatimpact the pharmaceutical industry. We willsurvey the recovery in clinical trial activitythat occurred as the pandemic gradually de-escalated to an endemic and how it reflects thecurrent clinical landscape. As of June 21, 2024, Trialtrove curated 9,959Phase I–III clinical trials (Table 1) investigatingat least one drug and with a disclosed startdate within the calendar year of 2023, returninggrowth of 9.4%, a remarkable recovery fromthe decline observed in 2022.1Looking at trialinitiations since 2020, the pandemic-relatedfluctuations seem to have abated somewhat.The rise and fall of infectious disease (ID) The A nnual Clinical T rials R oundup trial growth in Table 1. That trend broke in 2020due to the epic rise of non-industry-sponsoredCOVID trials (26% total trials vs. 5% industrytrials). However, excluding COVID trial countssignificantly narrowed that gap (-4% total trialsvs. -8% industry trials). The huge gain of 22%from excluding COVID trials in 2021 was largelynon-industry-sponsored, because only 6% wereaccounted for in industry-sponsored trials. Industry-sponsored trials, which accountedfor over 70% of all trials initiated in 2023, havebeen a driving force in clinical research. Beforeanalyzing the data to forecast the trajectoryof clinical trials activity, let’s evaluate theirperformance over the past five years, aspresented in Table 2. The growth of industry-sponsored trials during pre-pandemic years(2017–19) somewhat mirrored that of the total The A nnual Clinical T rials R oundup 2022 had fewer trial starts across all fronts, butnow we are starting to see industry-sponsoredtrials catching up as the number of COVIDtrials has diminished. 2023 certainly reflectsa stronger comeback for industry-sponsoredtrials. While the “COVID effect” peters out overthe last two years, clinical research in COVID-19is here to stay as a mainstay within the ID TA.Going forward, we may have reached the pointwhere we can scrap the “COVID effect” in futureanalyses. cheerfully forecasted plenty of sunshine inthe pipeline to hold off storm clouds on thehorizon.2The trajectory of the clinical trialsspace is on the up as well, with sunshine justpeering through the clouds. The cold realityof storm fronts tends to hit clinical trialsbefore its impact trickles down to early-stagedrug discovery, given the substantial cost ofrunning the trials. Funding is still hard to comeby, though there are creative avenues beingexplored through partnerships; navigating theregulatory guidance on DE&I in clinical planninghasn’t gotten easier; companies will continueto face legislative pressures on pricing; andwe are seeing lower success rates in clinicaldevelopment compared to a decade ago.3Letus brave the rabbit hole and unravel what 2023trial initiations can tell us. Despite that optimistic note of a glowing returnto trial starts in 2023, there remains a senseof restraint, as the overall increase of 9.4% stillfell short of the 12% year-over-year growthin pre-pandemic years. Our annual edi