参考文献
[1]颜虹,夏结来,于莉莉.临床试验中适应性设计研究进展[J].中华预防医学杂志,2008,42:16.
[2]范大超.临床试验方案的撰写——团队合作、质量控制及合约[J].中国处方药,2009,91(12):62-63.
[3]刘炳林.药物临床试验中疗效指标的选择[J].中国新药杂志,2017,26(18):2113-2120.
[4]潘长玉,李文慧,曾姣娥,等.阿格列汀治疗2型糖尿病的有效性与安全性[J].中华内科杂志,2015,54(11):949-953.
[5]Campbell G.Similarities and differences of Bayesian designs and adaptive designs for medical devices:a regulatory view[J].Stat Biopharm Res,2013,5:356-368.
[6]Chow SC,Chang M.Adaptive design methods in clinical trials[M].2nd ed.Boca Raton:Chapman&Hall/CRC,2012.
[7]Dixon WJ,Mood AM.A method for obtaining and analyzing sensitivity data[J].Journal of the American Statistical Association,1948,43:109-126.
[8]FDA.Guidance for industry.Patient-reported outcome measures:use in medical product development to support labeling claims[R/OL].(2009)[2019-12-16].https://www.fda.gov/media/77832/download.
[9]FDA.Surrogate endpoint resources for drug and biologic development[R/OL].(2018)[2019-3-16].https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/ucm606684.htm.
[10]Friedman FL,Furberg CD,DeMets DL.Fundamentals of clinical trials[M].4th ed.New York:Springer,2010.
[11]Gulley J.An open label phase I study to evaluate the safety and tolerability of GI-6301 vaccine consisting of whole,heat-killed recombinant saccharomyces cerevisiae(yeast)genetically modified to express brachyury protein in adults with solid tumors[R/OL].(2016)[2019-3-16].https://clinicaltrials.gov/ct2/show/NCT01519817?term=maximal+tolerated+dose&recrs=e&type=Intr&phase=04&u_sap=Yes&rank=6.
[12]Penel N,Kramar A.What does a modified-Fibonacci dose-escalation actually correspond to[J].BMC Medical Research Methodology,2012,12(1):103.
[13]Penta JS,Rozencweig M,Guarino AM.Mouse and large-animal toxicology studies of twelve antitumor agents:relevance to starting dose for Phase I clinical trials[J].Cancer Chemotherapy&Pharmacology,1979,3(2):97-101.
[14]Shih WJ.Plan to be flexible:a commentary on adaptive designs[J].Biometrical J,2006,48:656-659.
[15]Storer BE.Design and analysis of phase I clinical trials[J].Biometrics,1989,45(3):925-937.
[16]Todd S,Stallard NA.New clinical trial design combining phases 2 and 3:sequential designs with treatment selection and a change of endpoint[J].Drug Informat J,2005,39:109-118.