Clinical Trials Working Group

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. The Working Group includes members of the Department of Biostatistics and statisticians in industry and academia. The atmosphere is informal and discussion is strongly encouraged.


Interested speakers should contact Ludovic Trinquart, Robert Lew, or Gheorghe Doros.  Feel free to reach out to be added to the Working Group mailing list.



Date Speaker Title Location
Nov 12th @5pm Robert Lew Who needs a control group? CT-460A
Dec 10th @5pm Yuyin Liu Novel Statistical Methods for Multi-stage Designs in Clinical Trials with High Placebo Response CT-460A
Jan 23rd @5pm David Cheng Adaptive Combination of Conditional Treatment Effect Estimators Based on Randomized and Observational Data CT-305
Feb 27th @5pm Edwin van den Heuven Stepped-wedge RCTs: optimal designs and challenges CT-305
March 17th, @5pm Andrea Arfè Bayesian optimality of testing procedures for survival data in the non-proportional hazards setting Zoom
April 28th, @5pm Anne Eaton Non-parametric estimation in an illness-death model with component-wise censoring Zoom
May 12th, @5pm Antara Majumdar Bayesian Synthetic Controls in Clinical Drug Development Zoom
June 23rd, @5pm Matthew Psioda Bayesian Sequential Monitoring of Clinical Trials Zoom


Date Speaker Title Location Readings
Oct 6th @4pm Pranab Ghosh Multi-Arm Multi-Stage Design in Clinical Trials CT-332 Link to reading
Nov 3rd @4pm Ludovic Trinquart Type S errors and exaggeration ratios in cancer randomized trials CT-332
Nov 17th @4pm Isabelle Weir Design of noninferiority randomized trials using the difference in Restricted Mean Survival Times CT-332
Dec 1st @4pm Ina Jazic (HSPH) Composite endpoints in the semi-competing risks setting CT-332 Link to reading
Dec 15th @4pm Sara Lodi Causal inference methods for the per-protocol analysis of clinical trials CT-332
Jan 19th @4pm Brian Smith (Novartis) Impact of the choice of endpoint and analysis on the ability to discern treatment effects: Why does the underlying statistical distribution used matter? CT-332 Link to reading
Feb 2nd @4pm Robert Lew A Robust Method to Balance Factors over Time for Stepped Wedge Cluster Randomized Trials CT-332
Feb 16th @4pm Vivek Pradhan (Pfizer) Bias Reduction in Logistic Regression with Missing Responses when the Missing Data Mechanism is Nonignorable CT-332
Mar 30th @4pm Eleanor Murray (HSPH) Estimating per-protocol effects in randomized trials: using the placebo arm to assess confounding CT-332
TBD Ellie Gurary Type 1 Error Considerations in Superiority/Non-Inferiority Seamless Trial Design CT-332


Date Speaker Title Location Readings
October 12 @ 4:30pm Mark Chang Adaptive Dose-finding clinical trials CT-332 Link to reading #1
October 28 @ 4:30pm Ludovic Trinquart Meta-analysis of survival data from randomized trials using restricted mean survival times CT-332 Link to reading #1
November 9 @4:30pm Mizue Krygowski Personalized medicine integrated in Clinical Trial design CT-332 Link to reading #1
November 18 @4:30pm Meg Short PK variability in Phase I oncology trials CT-332 Link to reading #1
December 7 @4:30pm Mike LaValley Publication Bias in Meta-Analysis CT-332 Link to reading #1
December 16 @ 4:30pm Denis Rybin Treatment of dropout in clinical trials: A case study CT-332 Link to reading #1
January 11 @ 4:30pm Okwuokenye Macaulay Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free CT-332 Link to reading #1
January 27 @ 4:30pm Robert Lew Robust Priors for Small Samples CT-332 Link to reading #1
February 8 @ 4:30 pm Jeremiah Perez A comparison of risk measures in safety outcome trials designed to rule out excess risk CT-332 Link to reading #1
February 24, 2017 @4:30 Robert Lew Secondary Analyses for Clustered Trials CT-332 Link to reading #1
March 17 @4:30 Sandeep Menon Overview of personalized medicine designs CT-332 Link to reading #1
March 27 @4:30 pm Bo Yang Optimal group sequential design with flexible timing of sample size determination

CT-332 Link to reading #1
April 7 @4:30 pm Zhaoyang Teng Optimal Sample Size Planning for Phase II Trials CT-332 Link to reading #1
April 26 @4:30 pm Vivek Pradhan Appropriate binomial confidence interval to be used in practice
CT-332 Link to reading #1
May 17 @4:30 pm Sarah C. Conner Adjusted restricted mean survival times in observational studies CT-332 Link to reading #1