Bayesian Adaptive Methods for Clinical Trials
|
|
- Marvin Hardy
- 8 years ago
- Views:
Transcription
1 CENTER FOR QUANTITATIVE METHODS Department of Biostatistics COURSE: Bayesian Adaptive Methods for Clinical Trials Bradley P. Carlin (Division of Biostatistics, University of Minnesota) and Laura A. Hatfield (Dept. of Health Care Policy, Harvard Medical School) 8-9 October 2012 Location: Erasmus MC Room: Cf-328 Deadline for registration: 15 September For registration and further practical information, please contact Eline Van Gent Department of Biostatistics, Erasmus MC, Dr. Molewaterplein 50, 3015 GE Rotterdam, Ee 2124 (21 st floor), tel:
2 Abstract Thanks in large part to the rapid development of Markov chain Monte Carlo (MCMC) methods and software for their implementation. Bayesian methods have become ubiquitous in modern biostatistical analysis. In submissions to regulatory agencies where data on new drugs or medical devices are often scanty but researchers typically have access to large historical databases, Bayesian methods have emerged as particularly helpful in combining disparate sources of information while maintaining traditional frequents protections regarding Type I error and power. Biostatisticians in earlier phases (especially in oncology trials) have long appreciated Bayes ability to get good answers quickly. Finally, an increasing desire for adaptability in clinical trials (to react to trial knowledge as it accumulates) has also led to heightened interest in Bayesian methods. This two-day course begins with a brief introduction to Bayesian methods, computing, and software, and then goes on to elucidate their use in safety and efficacy trials of drugs and medical devices. In particular, we will illustrate how simulation may be used to calibrate a Bayesian procedure to guarantee good long-run frequents performance (i.e., low Type I and II error rates), a subject of keen ongoing interest to regulators. We also discuss Bayesian meta-analysis, and the closely related area of appropriate use of historical information in clinical trials. In terms of software, we will focus on BUGS and its variants (like Open BUGS and JAGS) as well as methods for calling it from R (such as R2WinBUGS, BRugs, and rjags), but also mention more recent developments, including both MCMC-based (e.g., PyMC, STAN/NUTS) and non-mcmc-based (INLA, ABC) alternatives. Students will be expected to bring their own laptop computers to the session, and to have recent versions of BUGS and R already installed on these computers. All necessary computer code will be provided during the two afternoon computer lab sessions, and the presence of two instructors will ensure adequate assistance for those who become lost during the presentation.
3 Recommended textbook: Berry, S.M., Carlin, B.P., Lee, J.J., and Muller, P. (2011). Bayesian Adaptive Methods for Clinical Trials, Boca Raton, FL: Chapman and Hall/CRC Press. (ISBN ) Options for obtaining the book include: 1. Buy it from the publisher using the promotion code 194CM on the CRC website to gain a 20% discount: The priced listed here is $94.95, but with the 20% discount this drops to $ Buy it direct from amazon.com: Cost using this method is currently $72.73, slightly cheaper (though this could change). Of course, other vendors and options (say, purchasing a used copy) may be even less expensive, but please be aware that we strongly suggest that each participant obtain his or her own copy of the book. Necessary background for the course Short course participants should be familiar with standard probability distributions (including normal, gamma, binomial, Poisson, beta, and multivariate normal) and statistical techniques (including linear regression, logistic regression, and the basics of generalized linear models). We will not assume significant previous experience with Bayesian data analysis or computing, although students with basic knowledge of these areas will certainly face a gentler learning curve. Chapter 2 of the textbook provides a quick review of Bayesian methods and computing for those who require it.
4 Target Audience Professional statisticians working in applied environments where hierarchical modelling and clinical trials are key issues, where flexible and adaptive methods are important, and where well justified approaches are needed for making informed inferences; this would include biostatisticians working in the pharmaceutical industry, regulatory agencies, or academic centers running large clinical trials Researchers and students from epidemiology, biostatistics, statistics, health services research, and related fields who are interested in gaining exposure to Bayesian adaptive methodology, either as a solution to their own challenging applied problems, or as an area of research in its own right
5 About the course instructors Brad Carlin is Mayo Professor in Public Health and Professor and Head of the Division of Biostatistics at the University of Minnesota. He has published more than 130 papers in refereed books and journals, and supervised or co-supervised 19 PhD dissertations to completion. He is co-author of three popular textbooks in Bayesian methods, the most recent of which ("Bayesian Adaptive Methods for Clinical Trials" with Scott Berry, J. Jack Lee, and Peter Muller) forms the primary text for this course. He is a winner of the Mortimer Spiegelman Award from the APHA, and from served as editor-in-chief of Bayesian Analysis, the official journal of the International Society for Bayesian Analysis (ISBA). Prof. Carlin has extensive experience teaching short courses and tutorials, and has won teaching awards from both the faculty and the graduate students at the University of Minnesota, as well as from the Joint Statistical Meetings CE program. During his spare time, Brad is a musician and bandleader, providing keyboards and vocals in a variety of venues, some of the more interesting of which are visible by typing the phrase "Bayesian cabaret" into the search window at YouTube. Laura Hatfield is an Assistant Professor of Health Care Policy, with a specialty in biostatistics, in the Department of Health Care Policy at Harvard Medical School. Dr. Hatfield's primary research interest is developing hierarchical Bayesian methods for analysis of complex health data including longitudinal patient-reported outcomes and survival in oncology clinical trials, consumer ratings of healthcare quality, and post-market surveillance of medical devices. Laura earned her BS in Genetics from Iowa State University and her MS and PhD in Biostatistics from the University of Minnesota. She was primary author of a complete solutions manual for Carlin & Louis' "Bayesian Methods for Data Analysis" (3rd ed), won several research and teaching awards at Minnesota, and co-taught or assisted short courses in Bayesian methods for the Biometric Society (ENAR), the New England Statistics Symposium, the Centers for Disease Control, and Yale University.
6 COURSE OUTLINE Day 1 9:00 10:45 Introduction: Motivation and overview, potential advantages, key differences with traditional methods (Ch 1, BCLM text) Review of Bayesian inference: prior determination, point and interval estimation, hypothesis testing, prediction, model choice (Sec BCLM) 10:45-11:00 Coffee break 11:00-12:30 Review of Bayesian computation: Markov chain Monte Carlo (MCMC) methods, Gibbs sampling, extensions (Sec 2.3 BCLM) 12:30-13:30 Lunch Basics of Bayesian clinical trial design: range of equivalence, community of priors, available software (Sec 2.5 BCLM) 13:30-15:00 Hierarchical modeling case studies: Hierarchical modeling and meta-analysis; survival analysis; joint longitudinal-survival modeling MCMC software options: R2WinBUGS, BRugs, mcmc, JAGS, and PyMC, extending WinBUGS to new distributions, simulation studies 15:00-15:15 Coffee break 15:15-17:00 Computer Lab session I: Demo and hands-on experimentation with R and WinBUGS for various models (simple failure rate; linear, nonlinear, and logistic regression, meta-analysis, survival modeling, joint longitudinal and survival modeling, etc.)
7 Day 2 9:00 11:00 Bayesian adaptive methods for safety studies: Rule- (3+3) and model-based (CRM, EWOC, TITE-CRM) designs for determining the maximum tolerated dose (MTD), efficacy and toxicity, combination therapy (Ch 3 BCLM) 11:00-11:30 Coffee break 11:30 12:30 Bayesian adaptive methods for efficacy studies: Standard designs, predictive probability-based methods, sequential stopping for futility, efficacy, and/or toxicity, adaptive randomization, biomarker-based adaptive designs (Ch 4 BCLM) 12:30-13:30 Lunch 13:30-15:00 Special topics: Methods for device trials, use of historical data in clinical trials, false discovery rate (FDR) in safety studies, incorporation of surrogate endpoints (Ch 6 BCLM) 15:00-15:15 Coffee break 15:15-17:00 Computer Lab session II: Practice with advanced, relevant R, WinBUGS, and BRugs software, opportunity for participants to install and try the programs themselves in real-data settings with one-on-one instructor guidance, wrap-up discussion, floor discussion, Q&A period
8 Administrative information Coffee breaks 2 coffee breaks (one in morning and one in afternoon) are included in the registration costs. Lunch is not included. Course materials Copies of the slides used in the course are included in the registration costs. Also a website is available with some computer code. Costs Erasmus University: 250,-, other universities/governmental: 500,- commercial organizations: 1500,- Registration is only effective upon receipt of payment. To register please fill the registration form and send it, in word-format, to: Secretariat.Biostatistics@ErasmusMC.nl
9 Afdeling Biostatistiek Department of Biostatistics Geachte heer / mevrouw, Dear Sir / Madam, Hierbij ontvangt u het aanmeldformulier voor Bayesian Adaptive Methods for Clinical Trials Uw aanmelding is pas definitief wanneer wij dit formulier retour ontvangen per of fax, volledig ingevuld en *ondertekend. U ontvangt een ter bevestiging. Secretariat.Biostatistics@ErasmusMC.nl Kosteloos annuleren is alleen mogelijk tot twee weken voor aanvang. Bij annulering binnen twee weken voor aanvang zijn wij genoodzaakt het gehele cursusbedrag in rekening te brengen. Please find enclosed the application form for Bayesian Adaptive Methods for Clinical Trials Your registration is only confirmed when we receive this form by or fax, completed and *signed. You will receive an to confirm this.. 250,- Erasmus participants. 500,- other universities.1500,- commercial companies Cancelation without penalty is only possible up to two weeks before start. If canceled within two weeks before start, we are forced to due the entire course fee. AANMELDFORMULIER / REGISTRATION FORM Universiteit / Organisatie: University / Organisation: Naam en voornaam: Surname and name: Adres: Address: Postcode en woonplaats: Zip code and residence: adres: address: Telefoon / Mobiel nr: Telephone / mobile no: BurgerServiceNummer: only residents of the Netherlands Factuuradres: Billing address: Postcode en woonplaats: Zip code and residence: BTW-nummer: VAT-number: **Kostenplaats nr: **Cost center no: Inkooporder nr: Purchase order no: Akkoord d.d.: Agreement d.d.: Naam en handtekening budget houder Name and signature of budget holder Naam in blokletters: Name in block letters: Handtekening: Signature: *Door ondertekening wordt de financiële verplichting aangegaan en zal de factuur door u worden voldaan. * By signing the financial obligation incurred and the invoice will be paid by you. **Intern EUR: kostenplaats nr en ondertekening machtigt de afd. Biostatistiek de gelden intern te verrekenen. **EUR Internal: cost center no. and signature authorizes the Department Biostatistics to settle funds internally.
Service courses for graduate students in degree programs other than the MS or PhD programs in Biostatistics.
Course Catalog In order to be assured that all prerequisites are met, students must acquire a permission number from the education coordinator prior to enrolling in any Biostatistics course. Courses are
More informationStatistics in Applications III. Distribution Theory and Inference
2.2 Master of Science Degrees The Department of Statistics at FSU offers three different options for an MS degree. 1. The applied statistics degree is for a student preparing for a career as an applied
More informationStatistics Graduate Courses
Statistics Graduate Courses STAT 7002--Topics in Statistics-Biological/Physical/Mathematics (cr.arr.).organized study of selected topics. Subjects and earnable credit may vary from semester to semester.
More informationA 6-day Course on Statistical Genetics
Study Coordinating Centre Hypertension and Cardiovascular Rehabilitation Unit Department of Cardiovascular Diseases University of Leuven A 6-day Course on Statistical Genetics 17-22 July 2006 The course
More informationProgramme Friday 19 September 2014
Programme Friday 19 September 2014 13:45 Assembling at Woodrow Wilsonplein Where? 14:00-15:30 Photo Rally in the city centre 15:30 End of the Photo Rally Where? Royal Conservatory, Hoogpoort 64 In front
More informationSTAT3016 Introduction to Bayesian Data Analysis
STAT3016 Introduction to Bayesian Data Analysis Course Description The Bayesian approach to statistics assigns probability distributions to both the data and unknown parameters in the problem. This way,
More informationSchool of Public Health and Health Services Department of Epidemiology and Biostatistics
School of Public Health and Health Services Department of Epidemiology and Biostatistics Master of Public Health and Graduate Certificate Biostatistics 0-04 Note: All curriculum revisions will be updated
More informationBayesian Phase I/II clinical trials in Oncology
Bayesian Phase I/II clinical trials in Oncology Pierre Mancini, Sandrine Micallef, Pierre Colin Séminaire JEM-SFES - 26 Janvier 2012 Outline Oncology phase I trials Limitations of traditional phase I designs
More informationClinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents
Clinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents J. Jack Lee, Ph.D. Department of Biostatistics 3 Primary Goals for Clinical Trials Test safety and
More informationGeorgia Tech College of Management
Best Practices in Developing an Effective Marketing Strategy Building Brand Loyalty Identifying and Segmenting Your Target Audience Georgia Tech College of Management Marketing Strategies: Building Brands
More informationBASIC COURSE IN STATISTICS FOR MEDICAL DOCTORS, SCIENTISTS & OTHER RESEARCH INVESTIGATORS INFORMATION BROCHURE
INDIAN COUNCIL OF MEDICAL RESEARCH BASIC COURSE IN STATISTICS FOR MEDICAL DOCTORS, SCIENTISTS & OTHER RESEARCH INVESTIGATORS October 13 th 17 th 2014 INFORMATION BROCHURE COURSE OFFERED BY Division of
More informationProof-of-Concept Studies and the End of Phase IIa Meeting with the FDA
Medpace Discovery Series presents Proof-of-Concept Studies and the End of Phase IIa Meeting with the FDA DR. JIM WEI: Today my topic is going to be Proof-of-Concept Studies and FDA End of Phase 2a Meetings
More informationHow To Design A Clinical Trial
BioBusiness BioEntrepreneurship Life Sciences Entrepreneurship BioClub BioClub BioBusiness Network at USI Clinical Trials Design and Management for Start-Up Companies LUGANO: 5-6 NOVEMBER 2012 SUPPORTED
More informationESTATED 5 JANUARI 1939. APPROVED BY ROYAL DECREE NO. 28 NOVEMBER 1967, NR. 39.
ESTATED 5 JANUARI 1939. APPROVED BY ROYAL DECREE NO. 28 NOVEMBER 1967, NR. 39. FENCING TEACHER: MAÎTRE FLORIS NONHEBEL, CELL: 06-52866680, E-MAIL: LERAARTERWEER@NONHEBEL.DEMON.NL CORRESPONDENCE: DHR. JOHAN
More informationAnalysis of microarray gene expression data using R/BioC and web tools Organised by MolMed 12 th edition, Erasmus MC, June 25-29, 2012 vs 120618
Analysis of microarray gene expression data using R/BioC and web tools Organised by MolMed 12 th edition, Erasmus MC, June 25-29, 2012 vs 120618 Course organizers and website Program: Dr. Judith Boer Pediatric
More informationA Simple Approach For Incorporating Multiple Toxicity Thresholds In Phase I Trials
A Simple Approach For Incorporating Multiple Toxicity Thresholds In Phase I Trials Jieling Miao and Shing M. Lee Columbia University, Department of Biostatistics May 20, 2015 Jieling Miao (Columbia University)
More informationF nest. Monte Carlo and Bootstrap using Stata. Financial Intermediation Network of European Studies
F nest Financial Intermediation Network of European Studies S U M M E R S C H O O L Monte Carlo and Bootstrap using Stata Dr. Giovanni Cerulli 8-10 October 2015 University of Rome III, Italy Lecturer Dr.
More informationThe Trials and Tribulations of the CRM: the DFO Experience
The Trials and Tribulations of the CRM: the DFO Experience Yuko Y. Palesch, PhD Professor and Director, Division of Biostatistics and Epidemiology Department of Medicine. Medical University of South Carolina
More informationApplied Missing Data Analysis in the Health Sciences. Statistics in Practice
Brochure More information from http://www.researchandmarkets.com/reports/2741464/ Applied Missing Data Analysis in the Health Sciences. Statistics in Practice Description: A modern and practical guide
More informationPackage bcrm. September 24, 2015
Type Package Package bcrm September 24, 2015 Title Bayesian Continual Reassessment Method for Phase I Dose-Escalation Trials Version 0.4.5 Date 2015-09-23 Author Michael Sweeting Maintainer Michael Sweeting
More informationUniversity of Maryland School of Medicine Master of Public Health Program. Evaluation of Public Health Competencies
Semester/Year of Graduation University of Maryland School of Medicine Master of Public Health Program Evaluation of Public Health Competencies Students graduating with an MPH degree, and planning to work
More informationCourse Requirements for the Ph.D., M.S. and Certificate Programs
Health Informatics Course Requirements for the Ph.D., M.S. and Certificate Programs Health Informatics Core (6 s.h.) All students must take the following two courses. 173:120 Principles of Public Health
More informationRebecca Yates Coley, Ph.D.
Rebecca Yates Coley, Ph.D. Department of Biostatistics Johns Hopkins University Baltimore, MD January 5, 2016 rycoley@gmail.com www.rycoley.com github: rycoley Education Ph.D., Biostatistics, University
More informationLongitudinal Modeling of Lung Function in Respiratory Drug Development
Longitudinal Modeling of Lung Function in Respiratory Drug Development Fredrik Öhrn, PhD Senior Clinical Pharmacometrician Quantitative Clinical Pharmacology AstraZeneca R&D Mölndal, Sweden Outline A brief
More informationAdaptive Design for Intra Patient Dose Escalation in Phase I Trials in Oncology
Adaptive Design for Intra Patient Dose Escalation in Phase I Trials in Oncology Jeremy M.G. Taylor Laura L. Fernandes University of Michigan, Ann Arbor 19th August, 2011 J.M.G. Taylor, L.L. Fernandes Adaptive
More informationModel-based Synthesis. Tony O Hagan
Model-based Synthesis Tony O Hagan Stochastic models Synthesising evidence through a statistical model 2 Evidence Synthesis (Session 3), Helsinki, 28/10/11 Graphical modelling The kinds of models that
More informationPharmacoeconomic, Epidemiology, and Pharmaceutical Policy and Outcomes Research (PEPPOR) Graduate Program
Pharmacoeconomic, Epidemiology, and Pharmaceutical Policy and Outcomes Research (PEPPOR) Graduate Program Front from left: 2010 Graduates Rupali Nail, PhD & Pallavi Jaiswal, MS; Back from left: PEPPOR
More informationSpecification of the Bayesian CRM: Model and Sample Size. Ken Cheung Department of Biostatistics, Columbia University
Specification of the Bayesian CRM: Model and Sample Size Ken Cheung Department of Biostatistics, Columbia University Phase I Dose Finding Consider a set of K doses with labels d 1, d 2,, d K Study objective:
More informationLikelihood Approaches for Trial Designs in Early Phase Oncology
Likelihood Approaches for Trial Designs in Early Phase Oncology Clinical Trials Elizabeth Garrett-Mayer, PhD Cody Chiuzan, PhD Hollings Cancer Center Department of Public Health Sciences Medical University
More informationCareers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA
PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical
More informationBOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH PUBLIC HEALTH COMPETENCIES
BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH PUBLIC HEALTH COMPETENCIES Competency-based education focuses on what students need to know and be able to do in varying and complex situations. These competencies
More informationBayesian Adaptive Designs for Early-Phase Oncology Trials
The University of Hong Kong 1 Bayesian Adaptive Designs for Early-Phase Oncology Trials Associate Professor Department of Statistics & Actuarial Science The University of Hong Kong The University of Hong
More informationRichard M. Heiberger Professor Emeritus of Statistics Temple University rmh@temple.edu January 2016
Richard M. Heiberger Professor Emeritus of Statistics Temple University rmh@temple.edu January 2016 Graphical Display of Data, Data Analysis, Data Visualization, Design of Experiments, Design of Software
More informationPsychology 209. Longitudinal Data Analysis and Bayesian Extensions Fall 2012
Instructor: Psychology 209 Longitudinal Data Analysis and Bayesian Extensions Fall 2012 Sarah Depaoli (sdepaoli@ucmerced.edu) Office Location: SSM 312A Office Phone: (209) 228-4549 (although email will
More informationMSCA 31000 Introduction to Statistical Concepts
MSCA 31000 Introduction to Statistical Concepts This course provides general exposure to basic statistical concepts that are necessary for students to understand the content presented in more advanced
More informationCOURSE PLAN BDA: Biomedical Data Analysis Master in Bioinformatics for Health Sciences. 2015-2016 Academic Year Qualification.
COURSE PLAN BDA: Biomedical Data Analysis Master in Bioinformatics for Health Sciences 2015-2016 Academic Year Qualification. Master's Degree 1. Description of the subject Subject name: Biomedical Data
More informationBayesian clinical trials in action
Special Issue Paper Received 14 March 2012, Accepted 15 March 2012 Published online 18 June 2012 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/sim.5404 Bayesian clinical trials in action
More informationUse advanced techniques for summary and visualization of complex data for exploratory analysis and presentation.
MS Biostatistics MS Biostatistics Competencies Study Development: Work collaboratively with biomedical or public health researchers and PhD biostatisticians, as necessary, to provide biostatistical expertise
More informationModule C5 Longitudinal Data Analysis
Stream C Advanced Module C5 Analysis 2-6 November 2015, The University of Queensland, Brisbane This five-day intensive course has been specifically designed to deepen the specialist knowledge of your research
More informationSensitivity Analysis in Multiple Imputation for Missing Data
Paper SAS270-2014 Sensitivity Analysis in Multiple Imputation for Missing Data Yang Yuan, SAS Institute Inc. ABSTRACT Multiple imputation, a popular strategy for dealing with missing values, usually assumes
More informationPLS 801: Quantitative Techniques in Political Science
PLS 801: Quantitative Techniques in Political Science Fall 2011 Tuesday/Thursday 12:40-2:00PM Instructor: Prof. Corwin D. Smidt Office: 320 S. Kedzie Hall Email: smidtc@msu.edu Do not expect replies to
More informationCourse Course Name # Summer Courses DCS Clinical Research 5103 Questions & Methods CORE. Credit Hours. Course Description
Course Course Name # Summer Courses Clinical Research 5103 Questions & Methods Credit Hours Course Description 1 Defining and developing a research question; distinguishing between correlative and mechanistic
More informationInfodossier: 3 Nations cup Peer. 29&30 augustus
Infodossier: 3 Nations cup Peer 29&30 augustus Ingang/entrance: Deusterstraat 74 3990 Peer. Parking 22 1 campsite Parking CLASSES o Championship Classes : Women Junior / Men Junior (only Sunday) Women
More informationFaculty of Science School of Mathematics and Statistics
Faculty of Science School of Mathematics and Statistics MATH5836 Data Mining and its Business Applications Semester 1, 2014 CRICOS Provider No: 00098G MATH5836 Course Outline Information about the course
More informationDepartment/Academic Unit: Public Health Sciences Degree Program: Biostatistics Collaborative Program
Department/Academic Unit: Public Health Sciences Degree Program: Biostatistics Collaborative Program Department of Mathematics and Statistics Degree Level Expectations, Learning Outcomes, Indicators of
More informationModel Calibration with Open Source Software: R and Friends. Dr. Heiko Frings Mathematical Risk Consulting
Model with Open Source Software: and Friends Dr. Heiko Frings Mathematical isk Consulting Bern, 01.09.2011 Agenda in a Friends Model with & Friends o o o Overview First instance: An Extreme Value Example
More informationObjections to Bayesian statistics
Bayesian Analysis (2008) 3, Number 3, pp. 445 450 Objections to Bayesian statistics Andrew Gelman Abstract. Bayesian inference is one of the more controversial approaches to statistics. The fundamental
More informationAnalyzing Clinical Trial Data via the Bayesian Multiple Logistic Random Effects Model
Analyzing Clinical Trial Data via the Bayesian Multiple Logistic Random Effects Model Bartolucci, A.A 1, Singh, K.P 2 and Bae, S.J 2 1 Dept. of Biostatistics, University of Alabama at Birmingham, Birmingham,
More informationAre you interested in health service delivery problems? Are you interested in modelling public health interventions?
Health Care Modelling, Systems Thinking & Design Thinking Workshop: What, Why & How? Are you interested in health service delivery problems? Are you interested in modelling public health interventions?
More informationNon-inferiority studies: non-sense or sense?
Non-inferiority studies: non-sense or sense? Prof. Emmanuel Lesaffre Department of Biostatistics, Erasmus MC, Rotterdam, the Netherlands L-Biostat, K.U.Leuven, Leuven, Belgium 1 2 3 1. Review of study
More informationGeorgia Tech College of Management
The Strategic View of Organizational Change Initiatives Understanding the Change Process Mastering the Different Change Roles and Phases Georgia Tech College of Management Applied Change Management: Effectively
More informationTesting Multiple Secondary Endpoints in Confirmatory Comparative Studies -- A Regulatory Perspective
Testing Multiple Secondary Endpoints in Confirmatory Comparative Studies -- A Regulatory Perspective Lilly Yue, Ph.D. Chief, Cardiovascular and Ophthalmic Devices Branch Division of Biostatistics CDRH/FDA
More informationBIOS 6660: Analysis of Biomedical Big Data Using R and Bioconductor, Fall 2015 Computer Lab: Education 2 North Room 2201DE (TTh 10:30 to 11:50 am)
BIOS 6660: Analysis of Biomedical Big Data Using R and Bioconductor, Fall 2015 Computer Lab: Education 2 North Room 2201DE (TTh 10:30 to 11:50 am) Course Instructor: Dr. Tzu L. Phang, Assistant Professor
More informationHealth Informatics Student Handbook
Health Informatics Student Handbook Interdisciplinary Graduate Program in Informatics (IGPI) Please see the Interdisciplinary Graduate Program in Informatics Handbook for more information regarding our
More informationCurriculum - Doctor of Philosophy
Curriculum - Doctor of Philosophy CORE COURSES Pharm 545-546.Pharmacoeconomics, Healthcare Systems Review. (3, 3) Exploration of the cultural foundations of pharmacy. Development of the present state of
More informationAssessing the Effect of Practical Considerations when using the CRM in Dose Finding Studies
Assessing the Effect of Practical s when using the CRM in Dose Finding Studies Caroline Sprecher, University of North Carolina-Chapel Hill Rolando Acosta Nuñez, University of Puerto Rico-Humacao Tyler
More informationCOLUMBIA UNIVERSITY IN THE CITY OF NEW YORK DEPARTMENT OF INDUSTRIAL ENGINEERING AND OPERATIONS RESEARCH
Course: IEOR 4575 Business Analytics for Operations Research Lectures MW 2:40-3:55PM Instructor Prof. Guillermo Gallego Office Hours Tuesdays: 3-4pm Office: CEPSR 822 (8 th floor) Textbooks and Learning
More informationGovernment of Russian Federation. Faculty of Computer Science School of Data Analysis and Artificial Intelligence
Government of Russian Federation Federal State Autonomous Educational Institution of High Professional Education National Research University «Higher School of Economics» Faculty of Computer Science School
More informationClinical and Translational Science
University of Illinois at Chicago 1 Clinical and Translational Science Mailing Address: School of Public Health (MC 923) 1603 West Taylor Street Chicago, IL 60612-4394 Contact Information: Campus Location:
More informationPEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Tatyana A Shamliyan. I do not have COI. 30-May-2012
PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to
More informationADDPLAN DF: Designing More Accurate Dose Escalation Studies in Exploratory Drug Development. An ICON White Paper
ADDPLAN DF: Designing More Accurate Dose Escalation Studies in Exploratory Drug Development An ICON White Paper Executive Summary The determination of the maximum tolerated dose (MTD) level is a critical
More informationPOL 204b: Research and Methodology
POL 204b: Research and Methodology Winter 2010 T 9:00-12:00 SSB104 & 139 Professor Scott Desposato Office: 325 Social Sciences Building Office Hours: W 1:00-3:00 phone: 858-534-0198 email: swd@ucsd.edu
More informationREGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology)
452 REGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology) (See also General Regulations) M.57 Admission requirements To be eligible for admission to the courses
More informationPublic Health/Applied Biostatistics, M.P.H.
Public Health/Applied Biostatistics, M.P.H. 1 Public Health/Applied Biostatistics, M.P.H. COLLEGE OF PUBLIC HEALTH (http://cph.temple.edu) About the Program The Master of Public Health with a concentration
More informationREGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology)
463 REGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology) (See also General Regulations) M.57 Admission requirements To be eligible for admission to the courses
More informationFoundations of Statistics Frequentist and Bayesian
Mary Parker, http://www.austincc.edu/mparker/stat/nov04/ page 1 of 13 Foundations of Statistics Frequentist and Bayesian Statistics is the science of information gathering, especially when the information
More informationModule C5 Longitudinal Data Analysis
Module C5 Analysis 24 28 November 2014, The University of Queensland, Brisbane This five-day intensive course has been specifically designed to deepen the specialist knowledge of your research teams and
More informationRichard M. Fairbanks School of Public Health Master of Public Health Program Final Concentration Project Proposal Form
Richard M. Fairbanks School of Public Health Master of Public Health Program Final Concentration Project Proposal Form Student Name: Advisor Name: Title of Project: Project Agency: Preceptor s E-mail Address:
More informationDoctor of Philosophy (Ph.D.) in Biostatistics
Doctor of Philosophy (Ph.D.) in Biostatistics Program Director: Administrative Assistant: Department: Website: K.B. Kulasekera, Ph.D. Lynne C. Dosker Bioinformatics and Biostatistics Ph.D. in Biostatistics
More informationModeling the Distribution of Environmental Radon Levels in Iowa: Combining Multiple Sources of Spatially Misaligned Data
Modeling the Distribution of Environmental Radon Levels in Iowa: Combining Multiple Sources of Spatially Misaligned Data Brian J. Smith, Ph.D. The University of Iowa Joint Statistical Meetings August 10,
More informationGMP-Z Annex 15: Kwalificatie en validatie
-Z Annex 15: Kwalificatie en validatie item Gewijzigd richtsnoer -Z Toelichting Principle 1. This Annex describes the principles of qualification and validation which are applicable to the manufacture
More informationVoorbeeld. Preview ISO 10018 INTERNATIONAL STANDARD. Quality management Guidelines on people involvement and competence
INTERNATIONAL STANDARD ISO 10018 First edition 2012-09-01 Quality management Guidelines on people involvement and competence Dit document mag slechts op een stand-alone PC worden geinstalleerd. Gebruik
More informationThoracic Oncology for the Non-Oncologist
Mayo Clinic Cancer Center Lung Cancer Symposium Thoracic Oncology for the Non-Oncologist $75 DISCOUNT for online registration! Go to www.mayo.edu/cme (offer expires October 12, 2011) Saturday, November
More informationStatistics Graduate Programs
Statistics Graduate Programs Kathleen Maurer, Coordinator of Graduate Studies 146 Middlebush Columbia, MO 65211 573-882-6376 http://www.stat.missouri.edu/ About Statistics The statistics department faculty
More informationMore details on the inputs, functionality, and output can be found below.
Overview: The SMEEACT (Software for More Efficient, Ethical, and Affordable Clinical Trials) web interface (http://research.mdacc.tmc.edu/smeeactweb) implements a single analysis of a two-armed trial comparing
More informationCMAP MOBILE APP TESTING FOUNDATION LEVEL
CMAP MOBILE APP TESTING FOUNDATION LEVEL Copyright 2014 ps_testware 1/6 Introduction Apps and mobiles have become an important element of today s IT and society in a very short time frame. Mobile technologies
More informationLeadership for Drug Development Teams
T U F T S C S D D P R E S E N T S Leadership for Drug Development Teams J U LY 8-9, 2014 DoubleTree by Hilton Hotel Boston, MA A leadership development opportunity with demonstrated results Create motivated,
More informationUptake of adaptive and Bayesian methods in the design of early phase trials within CTUs
Uptake of adaptive and Bayesian methods in the design of early phase trials within CTUs Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom PLEASE DO NOT REPRODUCE
More informationA Bayesian hierarchical surrogate outcome model for multiple sclerosis
A Bayesian hierarchical surrogate outcome model for multiple sclerosis 3 rd Annual ASA New Jersey Chapter / Bayer Statistics Workshop David Ohlssen (Novartis), Luca Pozzi and Heinz Schmidli (Novartis)
More informationApply with Resume to: www.rjrt.com Submenu Path Company/Careers/Current Openings/Job Type: Science
Position: Biostatistician Required Experience: At least 5 years This position is responsible for providing broad statistical support in general and biostatistical support specifically, including study
More informationSchool of Business TRINITY COLLEGE DUBLIN. Masters in Finance
Instructor: Dr. Gerald P. Dwyer Office: None Phone: +1-404-498-7095 Fax: +1-404-498-8810 E-mail: gpdwyer@gmail.com Office hours: by appointment via email School of Business TRINITY COLLEGE DUBLIN Masters
More information2015 TUHH Online Summer School: Overview of Statistical and Path Modeling Analyses
: Overview of Statistical and Path Modeling Analyses Prof. Dr. Christian M. Ringle (Hamburg Univ. of Tech., TUHH) Prof. Dr. Jӧrg Henseler (University of Twente) Dr. Geoffrey Hubona (The Georgia R School)
More information8 TH SUMMER COURSE ON VETERINARY EPIDEMIOLOGY
THE VETERINARY EPIDEMIOLOGY UNIT OF THE DEPARTMENT OF REPRODUCTION, OBSTETRICS AND HERD HEALTH OF THE FACULTY OF VETERINARY MEDICINE, GHENT UNIVERSITY, ORGANIZES 8 TH SUMMER COURSE ON VETERINARY EPIDEMIOLOGY
More informationClassroom Demonstrations of Big Data
Classroom Demonstrations of Big Data Eric A. Suess Abstract We present examples of accessing and analyzing large data sets for use in a classroom at the first year graduate level or senior undergraduate
More informationthe Future of engineering
the Future of engineering SpoorwegMuseum, Utrecht 19 November 2009 Intergraph and the Intergraph logo are registered trademarks of Intergraph Corporation. Other brands and product names are trademarks
More informationBehaviour Change Communication
Behaviour Change Communication Management Development Programme School of Public Health SRM Univesity SRM Nagar, Kattankulathur - 603 203 Kancheepuram Disttrict, Tamil nadu About the Course Behaviour change
More informationEXHIBITOR PROSPECTUS
American Stroke Association 4 th Annual Connecticut Stroke Conference: TRUMBULL MARRIOTT MERRITT PARKWAY, TRUMBULL, CT EXHIBITOR PROSPECTUS To Whom It May Concern: On behalf of the American Stroke Association,
More informationBayesian Model Averaging CRM in Phase I Clinical Trials
M.D. Anderson Cancer Center 1 Bayesian Model Averaging CRM in Phase I Clinical Trials Department of Biostatistics U. T. M. D. Anderson Cancer Center Houston, TX Joint work with Guosheng Yin M.D. Anderson
More informationThe Biostatistics Graduate Program at Boston University (MA/PhD) Program Handbook 2014-2015
The Biostatistics Graduate Program at Boston University (MA/PhD) Program Handbook 2014-2015 Biostatistics Program Contacts Biostatistics Department Mathematics Department sph.bu.edu/biostatistics math.bu.edu
More informationBayesian survival analysis in clinical trials: what methods are used in practice? A systematic review of the literature
1 Bayesian survival analysis in clinical trials: what methods are used in practice? A systematic review of the literature C. Brard 1,2, G. Le Teu 1,2, L.V Hampson 3, M-C. Le Deley 1,2 1 Biostatistics and
More informationTEACHING OF STATISTICS IN KENYA. John W. Odhiambo University of Nairobi Nairobi
TEACHING OF STATISTICS IN KENYA John W. Odhiambo University of Nairobi Nairobi In Kenya today statistics is taught at various levels in the education system to various degrees of coverage and sophistication.
More information11. Time series and dynamic linear models
11. Time series and dynamic linear models Objective To introduce the Bayesian approach to the modeling and forecasting of time series. Recommended reading West, M. and Harrison, J. (1997). models, (2 nd
More informationCBE 9190B ADVANCED STATISTICAL PROCESS ANALYSIS COURSE OUTLINE 2014 2015
CBE 9190B ADVANCED STATISTICAL PROCESS ANALYSIS COURSE OUTLINE 2014 2015 Description This course is for engineers involved with experimental investigation and interpretation of data. Basic, applied statistical
More informationThe Florida State University Department of Statistics Graduate Handbook. November 12, 2013
The Florida State University Department of Statistics Graduate Handbook November 12, 2013 1 Contents 1 Introduction... 3 2 Graduate Degrees... 3 2.1 Combined BS/MS Degree... 3 2.2 Master of Science Degrees...
More informationBayesian adaptive designs, with particular reference to dose finding methods in oncology
IV BIAS Annual Congress - Padova 27/09/2012 Advanced Methods in Clinical Trials: surrogate endpoints and adaptive designs Bayesian adaptive designs, with particular reference to dose finding methods in
More informationFor students starting Fall 2012. Health Education. program guide
For students starting Fall 2012 Health Education program guide Table of Contents From the Chair.... 1 A.T. Still University... 2 School of Health Management.... 2 Curriculum.... 2 Requirements for Admission....
More informationTRACTATENBLAD VAN HET KONINKRIJK DER NEDERLANDEN. JAARGANG 1962 Nr. 19
1 (1962) Nr. 1 TRACTATENBLAD VAN HET KONINKRIJK DER NEDERLANDEN JAARGANG 1962 Nr. 19 A. TITEL Overeenkomst tussen het Koninkrijk der Nederlanden en het Koninkrijk Zweden inzake het vestigen en onderhouden
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE CONDUCT OF POST-MARKETING SURVEILLANCE STUDIES OF VETERINARY MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/CVMP/044/99-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE CONDUCT
More informationBayesian Statistical Analysis in Medical Research
Bayesian Statistical Analysis in Medical Research David Draper Department of Applied Mathematics and Statistics University of California, Santa Cruz draper@ams.ucsc.edu www.ams.ucsc.edu/ draper ROLE Steering
More informationPractical considerations in designing a phase I Time to Event Continual Reassessment Method (TiTE CRM) trial in a grant funded CTU
Practical considerations in designing a phase I Time to Event Continual Reassessment Method (TiTE CRM) trial in a grant funded CTU Eleni Frangou 1, Jane Holmes 1, Sharon Love 1, Lang o Odondi 1,2, Claire
More information