---+ Clinical Trials Methodology * [[http://biostat.mc.vanderbilt.edu/TPT/TrialProtocolTool.html Trial Protocol Tool]] from http://www.practihc.org, the !PRACTIHC collaboration - Pragmatic RAndomized Controlled Trials in Health Care * Note: This resource is only to be used by nonprofit entities * %N% [[https://www.ctnbestpractices.org Clinical Trials Network]] best practices * %N% Penn State University's [[http://www.stat.psu.edu/online/courses/stat509 Design and Analysis of Clinical Trials]] course by Vernon Chinchilli and Rebecca Lengerich * [[%ATTACHURL%/samsizeRCT.pdf][Some Sample Size and Power Considerations for Clinical Studies]] * Papers on reporting of clinical trials from the [[http://www.consort-statement.org][CONSORT]] group: [[http://www.consort-statement.org/ene.pdf][Explanation and elaboration]] * [[http://www.consort-statement.org/newene.htm#glosstop][Glossary]] of clinical trials terms from CONSORT * Sample [[http://www.biostat.wisc.edu/Clinical_Trials/pdf/report1.pdf][graphical and tabular clinical trial report]] from the Statistical Data Analysis Center, Dept. of Biostatistics and Medical Informatics, U. Wisconsin-Madison. * Other [[StatGraphCourse][examples of graphical presentation of clinical data]] | [[Rreport][rreport]] * St. George's Hospital Medical School <a HREF="http://www.sghms.ac.uk/depts/phs/guide/guide.htm">Statistics Guide for Research Grant Applications</a>, including links to [[http://www.sghms.ac.uk/depts/phs/guide/randser.htm][Randomization Software and Services]] * [[http://clinicaltrialresults.org][Results]] of recent cardiovascular clinical trials. ---++ Advanced Clinical Trial Design * [[AdaptSeqBayesDes][Adaptive, sequential, Bayesian, and Phase II-III Bridging]] designs * [[TwoStageIntroduction][Two-stage designs]] * Biostatisticians very interested in advanced design: tatsuki.koyama@vanderbilt.edu, cindy.chen@vanderbilt.edu, lily.wang@vanderbilt.edu, f.harrell@vanderbilt.edu, yu.shyr@vanderbilt.edu, mary.dietrich@Vanderbilt.Edu, lei.xu@vanderbilt.edu, leene.choi@vanderbilt.edu, dan.ayers@vanderbilt.edu * Crossover trials: Cindy Chen, Dan Byrne * Titration studies: Mary Dietrich * Clinical researchers interested in advanced design: kathryn.edwards@Vanderbilt.Edu, beth.malow@Vanderbilt.Edu -- Main.FrankHarrell - 1 Feb, 8 Nov 2004, 15 Mar, 6 Jun 2008, 26 Dec 2009, 31 Dec 2010
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Sample Size Considerations in Randomized Trials
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