年度临床试验完成报告

Laura Runkel, PhDAssociate Director, Citeline Annual Completed Clinical Trials Report Introduction Trialtrove recorded 4,295 industry-sponsoredclinical trials from Phase I through PhaseIII/IV that either reached completed statusor reported primary endpoints during 2023.*This number is 10.7% higher than the 3,881completed trials in 2022 and reflects a return togrowth by this metric. Another 1,030 trials werereported as terminated in 2023, representingan 8.1% increase over 2022 terminations (953).Since 2020, the completed trials counts havealternated between annual decreases, in 2020and 2022, and increased trial completions, in2021 and 2023. TAs and central nervous system (CNS) returnedto the top three TAs (third place) for the firsttime since 2020. The broad increase in annualtrial completions reflects diminishing COVID-19pandemic disruptions on clinical trial activity. The high activity sponsored by the top 20group of companies dominates topline trialcounts again this year. All other pharma (AOP)companies continue to increase their share ofcompleted trials activity while occupying certaingeographic and disease focus niches. This whitepaper highlights how broad-based completedtrials growth is accompanied by higher successrates across multiple TAs, as pandemic-relateddisruptions and infectious disease-relatedactivity come to an end after three years ofoscillations. In contrast with the pandemic periodoscillations, all therapeutic areas (TAs) reportedhigher completions in 2023. Infectious diseases(ID) growth was negligible compared to other *The snapshot of clinical trials completed between Jan. 1, 2023 and Dec. 31, 2023 was taken on Feb. 14, 2024. Industry sponsors are classified as“Industry, Top 20 pharma” or “Industry, all other pharma.” Annual Completed Clinical Trials Report Topline Trial Landscape Metrics out ID. As ID drops in trial activity to fifth rank,it returns to its early pandemic period, 2020,position, albeit with far higher counts (648 vs.485). Cardiovascular (CV) reversed its trend ofdecreasing trial completions (2020–22). Vaccinestrial completions continue to grow and havenearly doubled since 2020. The four smallest TAshave retained the same rank order since at least2016. Ophthalmology and genitourinary (GU)also grew modestly in 2023. Oncology ranked number one for completedtrial activity again in 2023 (Table 1).Autoimmune/inflammation (A/I) retained second rank, as it has for three of the past fouryears. CNS returned to third rank, followingrelatively small annual changes during thepandemic years (2020–22). During that period,ID activity surged and nudged CNS from thetop three TAs. Metabolic/endocrinology (met/endo) returned to fourth place, narrowly edging Annual Completed Clinical Trials Report The cross-TA growth in 2023 trial activity isreminiscent of trends observed in the pre-pandemic years. The annual change rates for2019 to 2023 (Figure 1) illustrate volatility acrossall TAs during the pandemic years, 2020–22,while recent broad-based growth was similar to 2019 activity changes, when only ID andCV completions decreased relative to the prioryear. It will be interesting to track whetherrecent surges in CV trial activity translate intomeaningful developments in this TA. Annual Completed Clinical Trials Report oncology (62%; 264 of 427), vaccines (95%; 71 of77), and ophthalmology (33%; 7 of 31), comparedwith the mid-sized TAs, A/I (20%), CNS andmet/endo (15% each), and CV (11%) (data notshown). These TA-specific observations reflectvaried degrees of focus on early demonstrationof efficacy. Annual growth driven by increasedPhase I activity was most pronounced in CV(54% vs. 47%) and ID (39% vs. 33%), presumablyfrom new candidates in clinical development.Phase I activity in A/I, CNS, and oncologychanged, year-on-year, by only an average of1.7%, which suggests growth in these TAs wasmainly due to increased activity in later-stagetrials as successful clinical stage drugs moveforward. Distribution of 2023 completed trials bytherapeutic area and phase The distribution of trial counts by phase remainsthe same as that observed in our prior years’analyses, as later-phase counts (Phase II/III–III, III/IV) are typically lower for most TAsthan the early phases, I–I/II (Figure 2). Thisis as expected, in part due to higher hurdlesthat must be met to advance into larger-scale, late-stage trials. Oncology continues torun a relatively high proportion of Phase I/II trials (14%). Vaccines and ophthalmologyalso completed above average (7%) Phase I/IItrial activity, with 11% each. Efficacy endpointsare commonly evaluated in Phase I studies in Annual Completed Clinical Trials Report The top five diseases for trial completions in2023 (Table 2) were COVID-19, type 2 diabetes(T2D), non-small cell lung cancer (NSCLC),respiratory vaccines, and breast cancer.Trial activity for the top respiratory infection(COVID-19) has topped the disease list since2021 and includes trials that cross over torespi