探索亚太临床试验格局：问五个W

October 2024 Annie SiuDirector, APAC Content,Citeline Saakshi GuptaSenior Analyst,Oncology, Citeline Exploring the A sia-Pacific ClinicalTrials L andscape: A sking the F ive W ’ s Introduction Due to its abundant patient population anddiseases not being limited by borders, the Asia-Pacific (APAC) region, home to more than halfof the world’s population, has emerged as ahub for clinical trials in the global economy.Our previous white paper, “Asia Pacific as aClinical Trials Powerhouse1,” published in 2022,extensively examined the APAC clinical trialslandscape from 2012 to 2021. The observedgrowth in clinical trial activities during thisperiod was remarkable, highlighting the APACregion’s increased significance in globalresearch. At that time, we therefore anticipatedAPAC’s continued expansion and influence inglobal clinical activities. 2023. Our latest investigation examines the fivefundamental aspects — when, where, who, what,and why — of the APAC clinical trials landscape,drawing insights from Citeline’s Trialtroveplatform for clinical trial intelligence. As we analyze the data, it is essential toconsider three key points. Firstly, Trialtrovefocuses solely on drug clinical trials with aprospective time perspective. Studies purelyinvolving devices, surgical procedures,behavioral interventions, or retrospective dataare not included in this analysis. Secondly, trialinitiation figures are restricted to trials with adocumented actual start date available in thepublic domain, excluding those listed as plannedbut never confirmed to have commenced orlacking a disclosed start date. Reporting delaysin trial activities may affect recent years’statistics. Thirdly, we define the APAC region asencompassing locations categorized under the“Asia” and “Australia/Oceania” trial regions inTrialtrove. The evolving demands brought about by theCOVID-19 pandemic and the subsequentreopening phases are set to transform not onlythe global clinical trial environment, but also thelandscape trajectory of clinical trials within theAPAC region. This year, our analysis delves intothe APAC clinical trial landscape from 2019 to Exploring the A sia-Pacific ClinicalTrials L andscape: A sking the F ive W ’ s When did APAC become a clinical trialspowerhouse? The number of trials initiated in APACsurpassed the rest of the world (RoW) in 2021Our previous white paper illustrated the rise in compound annual growth rate (CAGR) of -1%(data not displayed). clinical trial activity in APAC from 2012 to 2021.Based on this trend, we anticipated that APACmay soon outpace the RoW in terms of clinicaltrial activity. It is important to mention thatRoW trials refer to studies that do not include aclinical site in the APAC region, although sometrials conducted in the APAC region may alsohave sites in other regions. As illustrated in Figure 1, there has been asignificant decrease in the number of trialsinitiated in the RoW. The total number of trialsthat started in the RoW decreased from 8,550in 2019 to 6,413 in 2023, with a CAGR of -6%.Meanwhile, trial activities in the APAC regionhave grown, surpassing the 2019 count in everysubsequent year. Examining this subject again reveals that theoverall number of Phase I-IV trials commencingaround the globe reached its peak in 2021,driven by the demand for COVID-19 treatments/vaccines during the pandemic. The total numberof trials globally decreased from 15,286 trialsin 2019 to 14,237 trials in 2023, resulting in a The total number of trials that started in APACincreased from 6,736 in 2019 to 7,824 in 2023,with a CAGR of 3%. It is important to highlightthat 55% of global trials included a trial locationin APAC in 2023, and the number of trialsinitiated in APAC has exceeded those in the RoWsince 2021 (Figure 1). Exploring the A sia-Pacific ClinicalTrials L andscape: A sking the F ive W ’ s Where are the top APAC trial locations? the only major APAC trial location experiencingpositive CAGR growth, at 8%. China, Japan, South Korea, India, andAustralia remain the Top 5 trial locationsin APAC In the 2019-23 period, Japan, SouthKorea, India, and Australia each initiatedapproximately one-tenth of the trials inthe APAC region (11%, 10%, 10%, and 9%,respectively), but these numbers havedeclined at CAGRs of -5%, -4%, -1%, and -1%,respectively. Only 8% of APAC trials includedsites in other APAC locations, with a CAGR of-4%. In summary, while trials in China are onthe rise, the rest of APAC countries are followingglobal trends with declining numbers. As was the case in our previous white paper,China, Japan, South Korea, India, and Australiahave continued to be the top trial locations inthe APAC region over the past five years (2019–23, Table 1). China has been the dominant force in drivingclinical trial activity in the APAC region, hosting62% of trials in the region (Table 1). This marksan increase from the 45% of trials that includeda Chinese site in the 2012-21 period, as outlinedin our earlier white paper.