Goals:
- Gain a common understanding on the desired goals of subgroup analyses
- Establish standards for assessing effects within subgroups and for defining meaningful differences in effect between subgroups
- Review the characteristics, assumptions, advantages and limitations of traditional and innovative models for subgroup analyses
- Review contribution of data visualization techniques to complement and enhance statistical modeling approaches and interpretation
- Develop and communicate recommendations
🎥 Watch the webinar recording:
Day 1: Monday, November 30, 2020
| TIME | PROPOSED AGENDA | PROPOSED SPEAKERS |
| 8:30-8:45 | Welcome Opening remarks (MRCT Center) | Richardae Araojo Sylva Collins Barbara Bierer |
| 8:45-9:10 | Keynote speaker: A clinical trialist’s perspective “System Redesign needed to make sense of findings that suggest heterogeneity of treatment effect” | Robert Califf |
| 9:10-10:15 | Challenges for the Regulator, Clinician, and Patient: Population safety and efficacy but individual treatment Moderator: David Strauss | Christopher Granger Ellis Unger Janet Wittes Donna Cryer Danielle Campbell Aloka Chakravarty |
| 10:15-10:30 | Break | |
| 10:30-11:00 | Goals of subgroup analyses, assessing standards for analysis of differences, and limits of interpretation | Steven Snapinn |
| 11:00-11:30 | Subgroup identification: Utility, impact, and methods | Scott Evans |
| 11:30-12:45 | Statistical Methods I Moderator: Li Chen | Stuart Pocock Stephen Ruberg Lisa Lavange Mark Rothmann Kathleen Fritsch Ravi Varadhan |
| 12:45-12:50 | Closing remarks | Richardae Araojo and Barbara Bierer |
Day 2: Tuesday, December 1, 2020
| Time | Proposed Agenda | Proposed Speakers |
| 8:30-9:30 | Statistical Methods II Moderator : Steve Snapinn | Donald Berry Thomas Louis Gene Pennello Frank Bretz |
| 9:30- 10:00 | Summary Discussion of Statistical Methods I and II | |
| 10:00-10:15 | Break | |
| 10:15-11:15 | Data Visualization and the role of graphical representation Moderator: Marcia Levenstein | Frank Harrell Ilya Lipkovich Michael Griswold |
| 11:15-12:15 | Panel: Statistical methodologies, pros and cons Moderator: Thomas Gwise | Frank Rockhold Qi Jiang Thomas Gwise John Scott |
| 12:15-12:45 | Open discussion and Conclusions | FDA and MRCT Center |
| 12:45- 1:00 | Core team to discuss Day 1 & Day 2 wrap up | Planning committee |