{"id":5,"date":"2016-09-23T09:41:42","date_gmt":"2016-09-23T13:41:42","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/ctwg\/clinical-trials-working-group\/"},"modified":"2020-05-13T13:29:49","modified_gmt":"2020-05-13T17:29:49","slug":"clinical-trials-working-group","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/ctwg\/","title":{"rendered":"Clinical Trials Working Group"},"content":{"rendered":"<p>The Clinical Trials Working Group provides a forum for faculty members and students to discuss current developments in statistical methods for clinical trials. It gives an opportunity to present preliminary work and to obtain feedback from the group.\u00a0The Working Group includes members of the Department of Biostatistics and statisticians in industry and academia. The atmosphere is informal and discussion is strongly encouraged.<\/p>\n<h3>Contact<\/h3>\n<p><span>Interested speakers should contact <a href=\"https:\/\/www.bumc.bu.edu\/ctwg\/wp-admin\/ludovic@bu.edu\">Ludovic Trinquart<\/a>, <a href=\"https:\/\/www.bumc.bu.edu\/ctwg\/wp-admin\/Robert.Lew2@va.gov\">Robert Lew<\/a>, or <\/span><a href=\"mailto:doros@bu.edu\">Gheorghe Doros<\/a><span>.\u00a0 Feel free to reach out to be added to the Working Group mailing list.<\/span><\/p>\n<h3>Schedule<\/h3>\n<p>2019-2020<\/p>\n<table width=\"959\" height=\"418\" style=\"height: 418px;\">\n<tbody>\n<tr style=\"background-color: #969696;\">\n<td><span style=\"color: #000000;\">Date<\/span><\/td>\n<td><span style=\"color: #000000;\">Speaker<\/span><\/td>\n<td><span style=\"color: #000000;\">Title<\/span><\/td>\n<td><span style=\"color: #000000;\">Location<\/span><\/td>\n<\/tr>\n<tr>\n<td>Nov 12th @5pm<\/td>\n<td>Robert Lew<\/td>\n<td>Who needs a control group?<\/td>\n<td>CT-460A<\/td>\n<\/tr>\n<tr>\n<td>Dec 10th @5pm<\/td>\n<td>Yuyin Liu<\/td>\n<td>Novel Statistical Methods for Multi-stage Designs in Clinical Trials with High Placebo Response<\/td>\n<td>CT-460A<\/td>\n<\/tr>\n<tr>\n<td>Jan 23rd @5pm<\/td>\n<td>David Cheng<\/td>\n<td>Adaptive Combination of Conditional Treatment Effect Estimators Based on Randomized and Observational Data<\/td>\n<td>CT-305<\/td>\n<\/tr>\n<tr>\n<td>Feb 27th @5pm<\/td>\n<td>Edwin van den Heuven<\/td>\n<td>Stepped-wedge RCTs: optimal designs and challenges<\/td>\n<td>CT-305<\/td>\n<\/tr>\n<tr>\n<td>March 17th, @5pm<\/td>\n<td>Andrea Arf\u00e8<\/td>\n<td>Bayesian optimality of testing procedures for survival data in the non-proportional hazards setting<\/td>\n<td>Zoom<\/td>\n<\/tr>\n<tr>\n<td>April 28th, @5pm<\/td>\n<td>Anne Eaton<\/td>\n<td>Non-parametric estimation in an illness-death model with component-wise censoring<\/td>\n<td>Zoom<\/td>\n<\/tr>\n<tr>\n<td>May 12th, @5pm<\/td>\n<td>Antara Majumdar<\/td>\n<td>Bayesian Synthetic Controls in Clinical Drug Development<\/td>\n<td>Zoom<\/td>\n<\/tr>\n<tr>\n<td>June 23rd, @5pm<\/td>\n<td>Matthew Psioda<\/td>\n<td>Bayesian Sequential Monitoring of Clinical Trials<\/td>\n<td>Zoom<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>2017-2018<\/p>\n<table width=\"959\" height=\"418\" style=\"height: 418px;\">\n<thead>\n<tr style=\"background-color: #969696;\">\n<td>Date<\/td>\n<td>Speaker<\/td>\n<td>Title<\/td>\n<td>Location<\/td>\n<td>Readings<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Oct 6<sup>th\u00a0<\/sup>@4pm<\/td>\n<td>Pranab Ghosh<\/td>\n<td>Multi-Arm Multi-Stage Design in Clinical Trials<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/biom.12687\/abstract\">Link to reading<\/a><\/td>\n<\/tr>\n<tr>\n<td>Nov 3<sup>rd<\/sup>\u00a0<span>@4pm<\/span><\/td>\n<td>Ludovic Trinquart<\/td>\n<td>Type S errors and exaggeration ratios in cancer randomized trials<\/td>\n<td><span>CT-332<\/span><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Nov 17<sup>th<\/sup>\u00a0<span>@4pm<\/span><\/td>\n<td>Isabelle Weir<\/td>\n<td>Design of noninferiority randomized trials using the difference in Restricted Mean Survival Times<\/td>\n<td>CT-332<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Dec 1<sup>st <\/sup>@4pm<\/td>\n<td>Ina Jazic (HSPH)<\/td>\n<td>Composite endpoints in the semi-competing risks setting<\/td>\n<td>CT-332<\/td>\n<td><a href=\"https:\/\/academic.oup.com\/jnci\/article\/doi\/10.1093\/jnci\/djw154\/2706925\/Beyond-Composite-Endpoints-Analysis-Semicompeting\">Link to reading<\/a><\/td>\n<\/tr>\n<tr>\n<td>Dec 15<sup>th<\/sup>\u00a0<span>@4pm<\/span><\/td>\n<td>Sara Lodi<\/td>\n<td>Causal inference methods for the per-protocol analysis of clinical trials<\/td>\n<td>CT-332<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Jan 19<sup>th<\/sup> @4pm<\/td>\n<td>Brian Smith (Novartis)<\/td>\n<td>Impact of the choice of endpoint and analysis on the ability to discern treatment effects: Why does the underlying statistical distribution used matter?<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/amstat.tandfonline.com\/doi\/abs\/10.1080\/19466315.2016.1238407#.WkukiFWnGJA\">Link to reading<\/a><\/td>\n<\/tr>\n<tr>\n<td>Feb 2<sup>nd<\/sup>\u00a0@4pm<\/td>\n<td>Robert Lew<\/td>\n<td>A Robust Method to Balance Factors over Time for Stepped Wedge\u00a0Cluster Randomized Trials<\/td>\n<td>CT-332<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Feb 16<sup>th<\/sup> @4pm<\/td>\n<td>Vivek Pradhan (Pfizer)<\/td>\n<td>Bias Reduction in Logistic Regression with Missing Responses when the Missing Data Mechanism is Nonignorable<\/td>\n<td><span>CT-332<\/span><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Mar 30th\u00a0<span>@4pm<\/span><\/td>\n<td>Eleanor Murray (HSPH)<\/td>\n<td>Estimating per-protocol effects in randomized trials: using the placebo arm to assess confounding<\/td>\n<td><span>CT-332<\/span><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>TBD<\/td>\n<td>Ellie Gurary<\/td>\n<td>Type 1 Error Considerations in Superiority\/Non-Inferiority Seamless\u00a0Trial Design<\/td>\n<td><span>CT-332<\/span><span><\/span><\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>2016-2017<\/p>\n<table width=\"962\" height=\"240\" style=\"height: 240px;\">\n<thead>\n<tr style=\"background-color: #969696;\">\n<td>Date<\/td>\n<td>Speaker<\/td>\n<td>Title<\/td>\n<td>Location<\/td>\n<td>Readings<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>October 12 @ 4:30pm<\/td>\n<td>Mark Chang<\/td>\n<td>Adaptive Dose-finding clinical trials<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/www.stat.columbia.edu\/~gelman\/research\/unpublished\/retropower.pdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>October 28 @ 4:30pm<\/td>\n<td>Ludovic Trinquart<\/td>\n<td>Meta-analysis of survival data from randomized trials using restricted mean survival times<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/ctj.sagepub.com\/content\/early\/2016\/06\/03\/1740774516649595.full.pdf+html\">Link to reading #1<\/a><\/td>\n<\/tr>\n<tr>\n<td>November 9 @4:30pm<\/td>\n<td>Mizue Krygowski<\/td>\n<td>Personalized medicine integrated in Clinical Trial design<\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4314682\/pdf\/bimj0057-0076.pdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>November 18 @4:30pm<\/td>\n<td>Meg Short<\/td>\n<td><span>PK variability in Phase I oncology trials<\/span><\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/ascopubs.org\/doi\/full\/10.1200\/JCO.2012.45.7903\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>December 7 @4:30pm<\/td>\n<td>Mike LaValley<\/td>\n<td>Publication Bias in Meta-Analysis<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsa065779\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>December 16 @ 4:30pm<\/td>\n<td>Denis Rybin<\/td>\n<td>Treatment of dropout in clinical trials: A case study<\/td>\n<td>CT-332<\/td>\n<td><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.1651\/epdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>January 11 @ 4:30pm<\/td>\n<td><span>Okwuokenye Macaulay<\/span><\/td>\n<td><span>Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free<\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"https:\/\/www.jstor.org\/stable\/pdf\/2529588.pdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>January 27 @ 4:30pm<\/td>\n<td>Robert Lew<\/td>\n<td>Robust Priors for Small Samples<\/td>\n<td>CT-332<\/td>\n<td><a href=\"ftp:\/\/ftp.biostat.wisc.edu\/pub\/chappell\/641\/papers\/paper21.pdf\">Link to reading #1<\/a><\/td>\n<\/tr>\n<tr>\n<td>February 8 @ 4:30 pm<\/td>\n<td>Jeremiah Perez<\/td>\n<td><span>A comparison of risk measures in safety outcome trials designed to rule out excess risk<\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4510023\/pdf\/nihms701443.pdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td>February 24, 2017 @4:30<\/td>\n<td><span>Robert Lew<\/span><\/td>\n<td>Secondary Analyses for Clustered Trials<\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"http:\/\/www.columbia.edu\/~jz2313\/sbw.pdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td><span>March 17 @4:30<\/span><\/td>\n<td><span>Sandeep Menon<\/span><\/td>\n<td><span>Overview of personalized medicine designs<\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><span>Link to reading #1<\/span><span><\/span><\/td>\n<\/tr>\n<tr>\n<td>March 27\u00a0@4:30 pm<\/td>\n<td>Bo Yang<\/td>\n<td>Optimal group sequential design with flexible timing of sample size determination<\/p>\n<p><span><\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><span>Link to reading #1<\/span><span><\/span><\/td>\n<\/tr>\n<tr>\n<td>April 7 @4:30 pm<\/td>\n<td><span>Zhaoyang Teng<\/span><\/td>\n<td><span>Optimal Sample Size Planning for Phase II Trials<\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.1717\/epdf\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<tr>\n<td><span>April 26 @4:30 pm<\/span><\/td>\n<td>Vivek Pradhan<\/td>\n<td>Appropriate binomial confidence interval to be used in practice<br \/>\n<span><\/span><\/td>\n<td><span>CT-332<\/span><span><\/span><\/td>\n<td><span>Link to reading #1<\/span><\/td>\n<\/tr>\n<tr>\n<td><span>May 17 @4:30 pm<\/span><\/td>\n<td>Sarah C. Conner<\/td>\n<td><span>Adjusted restricted mean survival times in observational studies<\/span><\/td>\n<td><span>CT-332<\/span><\/td>\n<td><a href=\"http:\/\/biostats.bepress.com\/cgi\/viewcontent.cgi?article=1224&amp;context=harvardbiostat\"><span>Link to reading #1<\/span><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Clinical Trials Working Group provides a forum for faculty members and students to discuss current developments in statistical methods for clinical trials. It gives an opportunity to present preliminary work and to obtain feedback from the group.\u00a0The Working Group includes members of the Department of Biostatistics and statisticians in industry and academia. The atmosphere [&hellip;]<\/p>\n","protected":false},"author":10952,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/pages\/5"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/users\/10952"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/comments?post=5"}],"version-history":[{"count":51,"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/pages\/5\/revisions"}],"predecessor-version":[{"id":101,"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/pages\/5\/revisions\/101"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/ctwg\/wp-json\/wp\/v2\/media?parent=5"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}