{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:34:25Z","timestamp":1777509265404,"version":"3.51.4"},"reference-count":111,"publisher":"Elsevier","isbn-type":[{"value":"9780444820617","type":"print"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1996]]},"DOI":"10.1016\/s0169-7161(96)13003-0","type":"book-chapter","created":{"date-parts":[[2005,4,18]],"date-time":"2005-04-18T19:58:53Z","timestamp":1113854333000},"page":"1-29","source":"Crossref","is-referenced-by-count":6,"title":["1 The design and analysis of clinical trials"],"prefix":"10.1016","author":[{"given":"Peter","family":"Armitage","sequence":"first","affiliation":[]}],"member":"78","reference":[{"key":"10.1016\/S0169-7161(96)13003-0_bib1","doi-asserted-by":"crossref","first-page":"3985","DOI":"10.1080\/03610929008830426","article-title":"Repeated measurements designs \u2014 A review","volume":"19","author":"Afsarinejad","year":"1990","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13003-0_bib2","doi-asserted-by":"crossref","first-page":"1209","DOI":"10.1002\/sim.4780081005","article-title":"A survey of models for repeated ordered categorical response data","volume":"8","author":"Agresti","year":"1989","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib3","series-title":"Categorical Data Analysis","author":"Agresti","year":"1990"},{"key":"10.1016\/S0169-7161(96)13003-0_bib4","doi-asserted-by":"crossref","first-page":"320","DOI":"10.1136\/bmj.296.6618.320","article-title":"Secondary prevention of vascular disease by prolonged antiplatelet treatment","volume":"296","year":"1988","journal-title":"British Med. J."},{"key":"10.1016\/S0169-7161(96)13003-0_bib5","doi-asserted-by":"crossref","first-page":"1395","DOI":"10.2105\/AJPH.48.10.1395","article-title":"Sequential methods in clinical trials","volume":"48","author":"Armitage","year":"1958","journal-title":"Amer. J. Public Health"},{"key":"10.1016\/S0169-7161(96)13003-0_bib6","series-title":"Sequential Medical Trials","author":"Armitage","year":"1975"},{"key":"10.1016\/S0169-7161(96)13003-0_bib7","doi-asserted-by":"crossref","first-page":"15","DOI":"10.2307\/1402871","article-title":"The search for optimality in clinical trials","volume":"53","author":"Armitage","year":"1985","journal-title":"Internat. Statist. Rev."},{"key":"10.1016\/S0169-7161(96)13003-0_bib8","doi-asserted-by":"crossref","first-page":"925","DOI":"10.1002\/sim.4780100613","article-title":"Interim analysis in clinical trials","volume":"10","author":"Armitage","year":"1991","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib9","series-title":"Multiple Comparisons, Selection Procedures and Applications in Biometry","first-page":"391","article-title":"Interim analyses in clinical trials","author":"Armitage","year":"1993"},{"key":"10.1016\/S0169-7161(96)13003-0_bib10","series-title":"Statistical Methods in Medical Research","author":"Armitage","year":"1994"},{"key":"10.1016\/S0169-7161(96)13003-0_bib11","doi-asserted-by":"crossref","first-page":"119","DOI":"10.2307\/2987883","article-title":"The two-period crossover trial","volume":"31","author":"Armitage","year":"1982","journal-title":"Statistician"},{"key":"10.1016\/S0169-7161(96)13003-0_bib12","doi-asserted-by":"crossref","first-page":"61","DOI":"10.2307\/2528460","article-title":"A two-period design with t2 experimental units","volume":"24","author":"Balaam","year":"1968","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib13","doi-asserted-by":"crossref","first-page":"1","DOI":"10.2307\/1402870","article-title":"On the allocation of treatments in sequential medical trials","volume":"53","author":"Bather","year":"1985","journal-title":"Internat. Statist. Rev."},{"key":"10.1016\/S0169-7161(96)13003-0_bib14","doi-asserted-by":"crossref","first-page":"419","DOI":"10.2307\/2982993","article-title":"Publication bias: A problem in interpreting medical data (with discussion)","volume":"151","author":"Begg","year":"1988","journal-title":"J. Roy. Statist. Soc. Ser. A"},{"key":"10.1016\/S0169-7161(96)13003-0_bib15","doi-asserted-by":"crossref","first-page":"81","DOI":"10.2307\/2530497","article-title":"A treatment allocation procedure for clinical trials","volume":"36","author":"Begg","year":"1980","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib16","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1002\/sim.4780080202","article-title":"A comparison of statistical methods for combining event rates from clinical trials","volume":"8","author":"Berlin","year":"1989","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib17","doi-asserted-by":"crossref","first-page":"469","DOI":"10.3109\/07357908709032904","article-title":"Interim analysis in clinical research","volume":"5","author":"Berry","year":"1987","journal-title":"Cancer Invest."},{"key":"10.1016\/S0169-7161(96)13003-0_bib18","doi-asserted-by":"crossref","first-page":"1377","DOI":"10.1002\/sim.4780121504","article-title":"A case for Bayesianism in clinical trials","volume":"12","author":"Berry","year":"1993","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib19","series-title":"Bandit Problems: Sequential Allocation of Experiments","author":"Berry","year":"1985"},{"key":"10.1016\/S0169-7161(96)13003-0_bib20","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1016\/0197-2456(92)90004-J","article-title":"A test for the difference between two treatments in a continuous measure of outcome when there are dropouts","volume":"13","author":"Brown","year":"1992","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib21","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/0197-2456(87)90023-7","article-title":"Projection from previous studies: A Bayesian and frequentist compromise","volume":"8","author":"Brown","year":"1987","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib22","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1016\/0021-9681(59)90004-9","article-title":"The historical development of clinical therapeutic trials","volume":"10","author":"Bull","year":"1959","journal-title":"J. Chronic Dis."},{"key":"10.1016\/S0169-7161(96)13003-0_bib23","series-title":"Cancer Clinical Trials: Methods and Practice","year":"1984"},{"key":"10.1016\/S0169-7161(96)13003-0_bib24","doi-asserted-by":"crossref","first-page":"337","DOI":"10.2307\/2529989","article-title":"Why data bases should not replace randomized clinical trials","volume":"36","author":"Byar","year":"1980","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib25","doi-asserted-by":"crossref","first-page":"1063","DOI":"10.1002\/sim.4780131008","article-title":"Crossover designs for clinical trials","volume":"13","author":"Carri\u00e8re","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib26","doi-asserted-by":"crossref","first-page":"971","DOI":"10.1002\/sim.4780100618","article-title":"Problems induced by meta-analysis","volume":"10","author":"Chalmers","year":"1991","journal-title":"Statist. Med."},{"issue":"Suppl. 1","key":"10.1016\/S0169-7161(96)13003-0_bib27","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1111\/j.1365-2036.1988.tb00761.x","article-title":"Meta-analysis of randomized control trials as a method of estimating rare complications of non-steroidal anti-inflammatory drug therapy","volume":"2","author":"Chalmers","year":"1988","journal-title":"Alim. Pharm. Therapeut."},{"key":"10.1016\/S0169-7161(96)13003-0_bib28","doi-asserted-by":"crossref","first-page":"841","DOI":"10.2307\/2532643","article-title":"Diagnostic plots in Cox's regression model","volume":"47","author":"Chen","year":"1991","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib29","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1093\/biomet\/68.1.119","article-title":"Sequential medical trials involving paired data","volume":"68","author":"Chernoff","year":"1981","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13003-0_bib30","series-title":"Effectiveness and Efficiency: Random Reflections on Health Services","author":"Cochrane","year":"1972"},{"key":"10.1016\/S0169-7161(96)13003-0_bib31","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1016\/S0140-6736(94)90006-X","article-title":"Concorde: MRC\/ANRS randomized double-blind controlled trial of immediate and deferred ziovudine in symptom-free HIV infection","volume":"343","author":"Concorde Coordinating Committee","year":"1994","journal-title":"Lancet"},{"key":"10.1016\/S0169-7161(96)13003-0_bib32","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/0197-2456(94)90025-6","article-title":"Intercept studies, clinical trials, and cluster experiments: To whom can we extrapolate?","volume":"15","author":"Cowan","year":"1994","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib33","series-title":"Analysis of Survival Data","author":"Cox","year":"1984"},{"key":"10.1016\/S0169-7161(96)13003-0_bib34","series-title":"Analysis of Binary Data","author":"Cox","year":"1989"},{"key":"10.1016\/S0169-7161(96)13003-0_bib35","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/0197-2456(86)90046-2","article-title":"Meta-analysis in clinical trials","volume":"7","author":"DerSimonian","year":"1986","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib36","series-title":"Treatment of Early Breast Cancer, Vol. 1: Worldwide Evidence 1985\u20131990","year":"1990"},{"key":"10.1016\/S0169-7161(96)13003-0_bib37_1","first-page":"1","article-title":"Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy","volume":"339","year":"1992","journal-title":"Lancet"},{"key":"10.1016\/S0169-7161(96)13003-0_bib37_2","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1016\/0140-6736(92)90997-H","article-title":"Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy","volume":"339","year":"1992","journal-title":"Lancet"},{"key":"10.1016\/S0169-7161(96)13003-0_bib38","doi-asserted-by":"crossref","first-page":"219","DOI":"10.2307\/2530762","article-title":"Three-period crossover designs for two treatments","volume":"40","author":"Ebbutt","year":"1984","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib39","series-title":"Proceedings of the Workshop on Practical Issues in Data Monitoring of Clinical Trials","first-page":"415","volume":"12","year":"1993"},{"key":"10.1016\/S0169-7161(96)13003-0_bib40","first-page":"503","article-title":"The arrangement of field experiments","volume":"33","author":"Fisher","year":"1926","journal-title":"J. Min. Agric. Great Britain"},{"key":"10.1016\/S0169-7161(96)13003-0_bib41","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1016\/0197-2456(86)90034-6","article-title":"Analysis of data from multiclinic trials","volume":"7","author":"Fleiss","year":"1986","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib42","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1016\/0197-2456(89)90065-2","article-title":"A critique of recent research on the two-treatment crossover design","volume":"10","author":"Fleiss","year":"1989","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib43","article-title":"Randomization or minimization in the treatment assignment of patient trials: Validity and power of tests","author":"Forsythe","year":"1977"},{"key":"10.1016\/S0169-7161(96)13003-0_bib44","doi-asserted-by":"crossref","first-page":"1421","DOI":"10.1002\/sim.4780081202","article-title":"The performance of the two-stage analysis of two-treatment, two-period crossover trials","volume":"8","author":"Freeman","year":"1989","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib45","series-title":"Fundamentals of Clinical Trials","author":"Friedman","year":"1985"},{"key":"10.1016\/S0169-7161(96)13003-0_bib46","doi-asserted-by":"crossref","first-page":"77","DOI":"10.2307\/2982670","article-title":"Analysis of multivariate data from four dental clinical trials","volume":"155","author":"Geary","year":"1992","journal-title":"J. Roy. Statist. Soc. Ser. A"},{"key":"10.1016\/S0169-7161(96)13003-0_bib47","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1056\/NEJM197401242900405","article-title":"Non-randomized controls in cancer clinical trials","volume":"290","author":"Gehan","year":"1974","journal-title":"New Eng. J. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib48","doi-asserted-by":"crossref","first-page":"1313","DOI":"10.1002\/sim.4780131305","article-title":"Stopping a clinical trial early: Frequentist and Bayesian approaches applied to a CALGB trial in non-small-cell lung cancer","volume":"13","author":"George","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib49","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1111\/j.2517-6161.1993.tb01468.x","article-title":"Modelling complexity: Applications of Gibbs sampling in medicine (with discussion)","volume":"55","author":"Gilks","year":"1993","journal-title":"J. Roy. Statist. Soc. Ser. B"},{"key":"10.1016\/S0169-7161(96)13003-0_bib50","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1002\/sim.4780090307","article-title":"Bias in the one-step method for pooling study results","volume":"9","author":"Greenland","year":"1990","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib51","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1016\/0197-2456(87)90158-9","article-title":"Letter to the Editor","volume":"8","author":"Grizzle","year":"1987","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib52","doi-asserted-by":"crossref","first-page":"1411","DOI":"10.1002\/sim.4780131316","article-title":"The case against independent monitoring committees","volume":"13","author":"Harrington","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib53","doi-asserted-by":"crossref","first-page":"793","DOI":"10.1259\/0007-1285-44-526-793","article-title":"Repeated assessment of results in clinical trials of cancer treatment","volume":"44","author":"Haybittle","year":"1971","journal-title":"British J. Radiol."},{"key":"10.1016\/S0169-7161(96)13003-0_bib54","series-title":"Statistical Methods in Clinical and Preventive Medicine","author":"Hill","year":"1962"},{"key":"10.1016\/S0169-7161(96)13003-0_bib55","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1016\/0140-6736(92)91893-D","article-title":"ISIS-3: A randomized trial of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41 299 cases of suspected acute myocardial infarction","volume":"339","year":"1992","journal-title":"Lancet"},{"key":"10.1016\/S0169-7161(96)13003-0_bib56","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1016\/S0140-6736(95)90865-X","article-title":"ISSI-4: A randomized factorial trial comparing oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction","volume":"345","year":"1995","journal-title":"Lancet"},{"key":"10.1016\/S0169-7161(96)13003-0_bib57","series-title":"Issues for Designing and Evaluating a \u2018Heroin Trial\u2019. Three Discussion Papers","first-page":"11","article-title":"An evaluation of possible designs for a heroin trial","author":"Jarrett","year":"1994"},{"key":"10.1016\/S0169-7161(96)13003-0_bib58","doi-asserted-by":"crossref","first-page":"305","DOI":"10.1111\/j.2517-6161.1989.tb01433.x","article-title":"Interim analyses: The repeated confidence interval approach (with discussion)","volume":"51","author":"Jennison","year":"1989","journal-title":"J. Roy. Statist. Soc. Ser. B."},{"key":"10.1016\/S0169-7161(96)13003-0_bib59","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1214\/ss\/1177012099","article-title":"Interim monitoring of clinical trials","volume":"5","author":"Jennison","year":"1990","journal-title":"Statist. Sci."},{"key":"10.1016\/S0169-7161(96)13003-0_bib60","series-title":"Design and Analysis of Cross-over Trials","author":"Jones","year":"1989"},{"key":"10.1016\/S0169-7161(96)13003-0_bib61","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1002\/sim.4780140206","article-title":"Meta-analysis: Weighing the evidence","volume":"14","author":"Jones","year":"1995","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib62","doi-asserted-by":"crossref","first-page":"1391","DOI":"10.1002\/sim.4780111012","article-title":"Sample size determination for group sequential clinical trials with immediate response","volume":"11","author":"Kim","year":"1992","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib63","doi-asserted-by":"crossref","first-page":"659","DOI":"10.2307\/2336502","article-title":"Discrete sequential boundaries for clinical trials","volume":"70","author":"Lan","year":"1983","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13003-0_bib64","first-page":"207","article-title":"Stochastically curtailed tests in long-term clinical trials","volume":"1","author":"Lan","year":"1982","journal-title":"Comm. Statist. C"},{"key":"10.1016\/S0169-7161(96)13003-0_bib65","doi-asserted-by":"crossref","first-page":"2339","DOI":"10.1080\/03610928408828830","article-title":"More flexible sequential and non-sequential designs in long-term clinical trials","volume":"13","author":"Lan","year":"1984","journal-title":"Comm. Statist. Theory Methods"},{"key":"10.1016\/S0169-7161(96)13003-0_bib66","doi-asserted-by":"crossref","first-page":"1485","DOI":"10.1002\/sim.4780131326","article-title":"Conclusions 1: The relationship between clinical trials and clinical practice: The risks of underestimating its complexity","volume":"13","author":"Liberati","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib67","series-title":"Statistical Tables for the Design of Clinical Trials","author":"Machin","year":"1987"},{"key":"10.1016\/S0169-7161(96)13003-0_bib68","doi-asserted-by":"crossref","first-page":"117","DOI":"10.2307\/1403636","article-title":"Recent developments in crossover designs","volume":"56","author":"Matthews","year":"1988","journal-title":"Internat. Statist. Rev."},{"key":"10.1016\/S0169-7161(96)13003-0_bib69","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1016\/0378-3758(94)90191-0","article-title":"Modelling and optimality in the design of crossover studies for medical applications","volume":"42","author":"Matthews","year":"1994","journal-title":"J. Statist. Plann. Inference"},{"key":"10.1016\/S0169-7161(96)13003-0_bib70","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1177\/096228029400300405","article-title":"Multi-period crossover trials","volume":"3","author":"Matthews","year":"1994","journal-title":"Statist. Methods Med. Res."},{"key":"10.1016\/S0169-7161(96)13003-0_bib71","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1136\/bmj.300.6719.230","article-title":"Analysis of serial measurements in medical research","volume":"300","author":"Matthews","year":"1990","journal-title":"British Med. J."},{"key":"10.1016\/S0169-7161(96)13003-0_bib72","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1136\/bmj.2.4582.769","article-title":"Streptomycin treatment of pulmonary tuberculosis: A report of the Streptomycin in Tuberculosis Trials Committee","volume":"2","author":"Medical Research Council","year":"1948","journal-title":"British Med. J."},{"key":"10.1016\/S0169-7161(96)13003-0_bib73","doi-asserted-by":"crossref","first-page":"1463","DOI":"10.1136\/bmj.1.4721.1463","article-title":"The prevention of whooping-cough by vaccination: A report of the Whooping-Cough Immunization Committee","volume":"1","author":"Medical Research Council","year":"1951","journal-title":"British Med. J."},{"key":"10.1016\/S0169-7161(96)13003-0_bib74","series-title":"Clinical Trials: Design, Conduct and Analysis","author":"Meinert","year":"1986"},{"key":"10.1016\/S0169-7161(96)13003-0_bib75","series-title":"Simultaneous Statistical Inference","author":"Miller","year":"1981"},{"key":"10.1016\/S0169-7161(96)13003-0_bib76","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1016\/0197-2456(89)90003-2","article-title":"Exact, conditional, and predictive power in planning clinical trials","volume":"10","author":"Moussa","year":"1989","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib77","doi-asserted-by":"crossref","first-page":"549","DOI":"10.2307\/2530245","article-title":"A multiple testing procedure for clinical trials","volume":"35","author":"O'Brien","year":"1979","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib78","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1002\/sim.4780060306","article-title":"Why do we need systematic overviews of randomized trials?","volume":"6","author":"Peto","year":"1987","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib79","doi-asserted-by":"crossref","first-page":"585","DOI":"10.1038\/bjc.1976.220","article-title":"Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design","volume":"34","author":"Peto","year":"1976","journal-title":"British J. Cancer"},{"key":"10.1016\/S0169-7161(96)13003-0_bib80","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1016\/0197-2456(93)90037-E","article-title":"Letter to the Editor: Politically correct clinical trials","volume":"14","author":"Piantodosi","year":"1993","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib81","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1093\/biomet\/64.2.191","article-title":"Group sequential methods in the design and analysis of clinical trials","volume":"64","author":"Pocock","year":"1977","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13003-0_bib82","series-title":"Clinical Trials: A Practical Approach","author":"Pocock","year":"1983"},{"key":"10.1016\/S0169-7161(96)13003-0_bib83","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1002\/sim.4780090612","article-title":"Estimation issues in clinical trials and overviews","volume":"9","author":"Pocock","year":"1990","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib84","first-page":"5","article-title":"The size of cancer clinical trials: An international survey","volume":"36","author":"Pocock","year":"1978","journal-title":"UICC Tech. Rep. Ser."},{"key":"10.1016\/S0169-7161(96)13003-0_bib85","doi-asserted-by":"crossref","first-page":"487","DOI":"10.2307\/2531989","article-title":"The analysis of multiple endpoints in clinical trials","volume":"43","author":"Pocock","year":"1987","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib86","series-title":"Clinical Trials","author":"Schwartz","year":"1980"},{"key":"10.1016\/S0169-7161(96)13003-0_bib87","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1016\/0021-9681(67)90041-0","article-title":"Explanatory and pragmatic attitudes in therapeutic trials","volume":"20","author":"Schwartz","year":"1967","journal-title":"J. Chronic Dis."},{"key":"10.1016\/S0169-7161(96)13003-0_bib88","doi-asserted-by":"crossref","first-page":"715","DOI":"10.1002\/sim.4780110603","article-title":"Is the \u2018simple carry-over\u2019 model useful?","volume":"11","author":"Senn","year":"1992","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib89","series-title":"Cross-over Trials in Clinical Research","author":"Senn","year":"1993"},{"key":"10.1016\/S0169-7161(96)13003-0_bib90","series-title":"Theory of Optimal Designs","author":"Shah","year":"1989"},{"key":"10.1016\/S0169-7161(96)13003-0_bib91","series-title":"Clinical Trials: Issues and Approaches","year":"1983"},{"key":"10.1016\/S0169-7161(96)13003-0_bib92","doi-asserted-by":"crossref","first-page":"1289","DOI":"10.1002\/sim.4780131303","article-title":"Proceedings of the Workshop on Early Stopping Rules in Cancer Clinical Trials","volume":"13","author":"Souhami","year":"1994","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib93","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1002\/sim.4780050103","article-title":"A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion","volume":"5","author":"Spiegelhalter","year":"1986","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib94","series-title":"Bayesian Statistics, 3","first-page":"453","article-title":"Bayesian approaches to clinical trials","author":"Spiegelhalter","year":"1988"},{"key":"10.1016\/S0169-7161(96)13003-0_bib95","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1016\/0197-2456(86)90003-6","article-title":"Monitoring clinical trials: Conditional or predictive power?","volume":"7","author":"Spiegelhalter","year":"1986","journal-title":"Cont. Clin. Trials"},{"key":"10.1016\/S0169-7161(96)13003-0_bib96","doi-asserted-by":"crossref","first-page":"1501","DOI":"10.1002\/sim.4780121516","article-title":"Applying Bayesian thinking in drug development and clinical trials","volume":"12","author":"Spiegelhalter","year":"1993","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib97","doi-asserted-by":"crossref","first-page":"357","DOI":"10.2307\/2983527","article-title":"Bayesian approaches to randomized trials (with discussion)","volume":"157","author":"Spiegelhalter","year":"1994","journal-title":"J. Roy. Statist. Soc. Ser. A"},{"key":"10.1016\/S0169-7161(96)13003-0_bib98","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1177\/096228029400300401","volume":"3","year":"1994","journal-title":"Statistical Methods in Medical Research"},{"key":"10.1016\/S0169-7161(96)13003-0_bib99","first-page":"287","article-title":"The effect of NaF and SMFP toothpastes on three-year caries increments in adolescents","volume":"44","author":"Stephen","year":"1994","journal-title":"Internat. Dent. J."},{"key":"10.1016\/S0169-7161(96)13003-0_bib100","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1002\/cpt1974155443","article-title":"Minimization: A new method of assigning patients to treatment and control groups","volume":"15","author":"Taves","year":"1974","journal-title":"Clin. Pharmacol. Ther."},{"key":"10.1016\/S0169-7161(96)13003-0_bib101","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1093\/biomet\/77.1.147","article-title":"Martingale-based residuals for survival models","volume":"77","author":"Therneau","year":"1990","journal-title":"Biometrika"},{"key":"10.1016\/S0169-7161(96)13003-0_bib102","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1214\/ss\/1177012384","article-title":"Investigating therapies of potentially great benefit: ECMO (with discussion)","volume":"4","author":"Ware","year":"1989","journal-title":"Statist. Sci."},{"key":"10.1016\/S0169-7161(96)13003-0_bib103","series-title":"The Design and Analysis of Sequential Clinical Trials","author":"Whitehead","year":"1992"},{"key":"10.1016\/S0169-7161(96)13003-0_bib104","doi-asserted-by":"crossref","first-page":"1665","DOI":"10.1002\/sim.4780101105","article-title":"A general parametric approach to the meta-analysis of randomized clinical trials","volume":"10","author":"Whitehead","year":"1991","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib105","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1002\/sim.4780070134","article-title":"Analyzing changes in the presence of informative right censoring caused by death and withdrawal","volume":"7","author":"Wu","year":"1988","journal-title":"Statist. Med."},{"key":"10.1016\/S0169-7161(96)13003-0_bib106","doi-asserted-by":"crossref","first-page":"939","DOI":"10.2307\/2531694","article-title":"Estimation and comparison of changes in the presence of informative right censoring: Conditional linear model","volume":"45","author":"Wu","year":"1989","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib107","doi-asserted-by":"crossref","first-page":"175","DOI":"10.2307\/2531905","article-title":"Estimation and comparison of changes in the presence of informative right censoring by modelling the censoring process","volume":"44","author":"Wu","year":"1988","journal-title":"Biometrics"},{"key":"10.1016\/S0169-7161(96)13003-0_bib108","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1016\/S0033-0620(85)80003-7","article-title":"Beta-blockade during and after myocardial infarction: An overview of the randomized clinical trials","volume":"27","author":"Yusuf","year":"1985","journal-title":"Prog. Cardiovasc. Dis."},{"key":"10.1016\/S0169-7161(96)13003-0_bib109","series-title":"Proceedings of the Workshop on Methodologic Issues in Overviews of Randomized Clinical Trials","first-page":"217","volume":"6","year":"1987"},{"key":"10.1016\/S0169-7161(96)13003-0_bib110","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1080\/01621459.1969.10500959","article-title":"Play the winner rule and the controlled clinical trial","volume":"64","author":"Zelen","year":"1969","journal-title":"J. Amer. Statist. Assoc."}],"container-title":["Handbook of Statistics","Design and Analysis of Experiments"],"original-title":[],"language":"en","deposited":{"date-parts":[[2024,12,31]],"date-time":"2024-12-31T19:30:25Z","timestamp":1735673425000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0169716196130030"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1996]]},"ISBN":["9780444820617"],"references-count":111,"URL":"https:\/\/doi.org\/10.1016\/s0169-7161(96)13003-0","relation":{},"ISSN":["0169-7161"],"issn-type":[{"value":"0169-7161","type":"print"}],"subject":[],"published":{"date-parts":[[1996]]}}}