[1]LLEWELLYN-BENNETT R,EDWARDS D,ROBERTS N,et al. Post-trial follow-up methodology in large randomised controlled trials:a systematic review[J]. Trials,2018,19(1):298.
[2]TANG R,SHEN J,YUAN Y. ComPAS:a bayesian drug combination platform trial design with adaptive shrinkage[J]. Stat Med,2019,38(7):1120-1134.
[3]MEYER E L,MESENBRINK P,DUNGER-BALDAUF C,et al. The evolution of master protocol clinical trial designs:a systematic literature review[J]. Clin Ther,2020,42(7):1330-1360.
[4]WOODCOCK J,LAVANGE L M. Master protocols to study multiple therapies,multiple diseases,or both[J]. N Engl J Med,2017,377(1):62-70.
[5]Food and Drug Administration. Master protocols:efficient clinical trial design strategies to expedite development of oncology drugs and biologics guidance for industry[EB/OL].(2018-09-28)[2023-04-16]. https://www.fda.gov/media/120721/download.
[6]BOGIN V. Master protocols:new directions in drug discovery[J/OL]. Contemp Clin Trials Commun,2020,18:100568[2023-04-16]. https://doi.org/10.1016/j.conctc.2020.100568.
[7]国家药品监督管理局. 药物临床试验适应性设计指导原则(试行)[EB/OL].(2011-12-02)[2023-04-16]. https://www.cde.org.cn/main/news/viewInfoCommon/bc2b326bd49bac7437368272be6ec00d.
[8]PARK J J H,HARARI O,DRON L,et al. An overview of platform trials with a checklist for clinical readers[J/OL]. J Clin Epidemiol,2020,125:1-8[2023-04-16]. https://doi.org/10.1016/j.jclinepi.2020.04.025.
[9]张怡君,田雪,胥芹,等. 篮式研究和伞式研究及案例分析[J]. 中国卒中杂志,2023,18(2):240-243.
[10]JAMES N D,SYDES M R,CLARKE N W,et al. Addition of docetaxel,zoledronic acid,or both to first-line long-term hormone therapy in prostate cancer(STAMPEDE):survival results from an adaptive,multiarm,multistage,platform randomised controlled trial[J]. Lancet,2016,387(10024):1163-1177.
[11]SYDES M R,PARMAR M K,MASON M D,et al. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE:a multi-arm multi-stage randomized controlled trial[J/OL]. Trials,2012,13:168[2023-04-16]. https://doi.org/10.1186/1745-6215-13-168.
[12]BARKER A D,SIGMAN C C,KELLOFF G J,et al. I-SPY 2:an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy[J]. Clin Pharmacol Ther,2009,86(1):97-100.
[13]SYDES M R,PARMAR M K,JAMES N D,et al. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer:the MRC STAMPEDE trial[J/OL]. Trials,2009,10:39[2023-04-16]. https://doi.org/10.1186/1745-6215-10-39.
[14]SCHIAVONE F,BATHIA R,LETCHEMANAN K,et al. This is a platform alteration:a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols[J]. Trials,2019,20(1):264.
[15]HAGUE D,TOWNSEND S,MASTERS L,et al. Changing platforms without stopping the train:experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons[J]. Trials,2019,20(1):294.
[16]THORLUND K,HAGGSTROM J,PARK J J,et al. Key design considerations for adaptive clinical trials:a primer for clinicians[J/OL]. BMJ,2018,360:k698[2023-04-16]. https://doi.org/10.1136/bmj.k698.
[17]PARK J J,THORLUND K,MILLS E J. Critical concepts in adaptive clinical trials[J/OL]. Clin Epidemiol,2018,10:343-351[2023-04-16].
https://doi.org/10.2147/clep.s156708.
[18]PRENTICE R L. Surrogate endpoints in clinical trials:definition and operational criteria[J]. Stat Med,1989,8(4):431-440.
[19]BEAUCHEMIN C,JOHNSTON J B,LAPIERRE M,et al. Relationship between progression-free survival and overall survival in chronic lymphocytic leukemia:a literature-based analysis[J/OL]. Curr Oncol,2015,22(3):e148-156[2023-04-10]. https://doi.org/10.3747/co.22.2119.
[20]TANEJA S S. Re:addition of docetaxel,zoledronic acid,or both to first-line long-term hormone therapy in prostate cancer(STAMPEDE):survival results from an adaptive,multiarm,multistage,platform randomised controlled trial[J]. J Urol,2016,196(4):1124-1125.
[21]STERNBERG C N. Re:addition of docetaxel,zoledronic acid,or both to first-line long-term hormone therapy in prostate cancer(STAMPEDE):survival results from an adaptive,multiarm,multistage,platform randomised controlled trial[J]. Eur Urol,2016,69(6):1155-1156.
[22]RECOVERY Collaborative Group. Randomised evaluation of COVID-19 therapy(RECOVERY)[EB/OL].(2020-07-23)[2023-04-16]. https://www.recoverytrial.net/.
[23]HIRAKAWA A,ASANO J,SATO H,et al. Master protocol trials in oncology:review and new trial designs[J/OL]. Contemp Clin Trials Commun,2018,12:1-8[2023-04-16]. https://doi.org/10.1016/j.conctc. 2018.08.009.
[24]关之玥,刘岩,张晶晶,等. 母方案平台试验设计方法及其在相关领域中的应用[J]. 中国循证医学杂志,2021,21(8):986-992.