There has been increasing interest in subgroup analysis as part of drug development. There are a wide variety of motivations for such analysis, for example, finding subgroups with the best benefit-risk tradeoff, identifying super- or non-responders or subgroups with an unacceptable safety profile. Situations can range from confirmation of responses that were highly anticipated at the design stage to data-driven ad hoc analysis to salvage an experimental treatment. Moreover, with the increasing abundance of data available to subdivide the population, including demographic, clinical, and -omics, there has been great interest in exploring the possibilities. This meetup will attempt to frame some of the important issues around the use of subgroup analysis in drug development and provide consideration from both a practitioner’s and regulator’s prospective.
Below are links to the slides. Speakers are listed below as well and a recording of the complete conversation.
| Attachment | Size |
|---|---|
 1_Lipkovich_NISS Webinar.pdf | 684.45 KB |
| 2_Hemming_Science demands subgroups.pdf | 722.3 KB |
| 3_Ruberg - To Be Or Not To Be.pdf | 1.51 MB |
Agenda
Confirmed speakers for this event and the titles for their talks are:
Ilya Lipkovich, (Lily)
"Overview of methods for subgroup identification in clinical trials"
Rob Hemmings, (Consilium Salmonson and Hemmings)
"Science demands subgroups: improving analysis and use in decision making"
Stephen Ruberg, (Analytix Thinking)
"To Be Or Not To Be (A Subgroup)"
Event Type
- Affiliate Award Fund Eligible
- NISS Hosted
- NISS Sponsored