---+ 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 * [[https://www.ctnbestpractices.org Clinical Trials Network]] best practices * [[http://www.researchtoolkit.org Research Toolkit]]: Better Tools for Multi-site Research <!-- * 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/about-consort/history/explanation--elaboration-document-ee/][Explanation and elaboration]] * [[http://www.consort-statement.org/resources/glossary/][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-users.york.ac.uk/~mb55/guide/guide14.pdf">Statistics Guide for Research Grant Applications</a>, including links to [[http://www-users.york.ac.uk/~mb55/guide/randsery.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, 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, 26 Mar 2012
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Sample Size Considerations in Randomized Trials
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