Series 3: Regulatory statistics
November 24, 2017
| Date | Location | Topic |
|---|---|---|
| January 11th 2018 | CEB | ICH E9 Addendum and Per-Protocol Analyses of Pragmatic Trials |
| February 8th 2018 | Swiss TPH | Estimands and Their Role in Clinical Trials |
| March 8th 2018 | CEB | A taxonomy of estimands for regulatory clinical trials with discontinuations |
| April 12th 2018 | Swiss TPH | Estimands in clinical trials broadening the perspective (possibly with comments) |
| May 17th 2018 | CEB | Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance (Parts I to III) |
| June 14th 2018 | Swiss TPH | Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance (Parts IV to V) |
Following up on the 2nd EFSPI Workshop on Regulatory Statistics, on October 5-6th 2017 in Basel
Regulatory guidelines around multiple endpoints
- Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance
Announcement on RAPS (Regulatory Affairs Professionals Society )
- EMA Guideline on multiplicity issues in clinical trials Draft
Update of the ICH E9 to include the concept and semantics of estimands
- ICH E9 Addendum
- Per-Protocol Analyses of Pragmatic Trials
Miguel A. Hernán and James M. Robins
Statistics in Medicine, 2017 - Estimands and Their Role in Clinical Trials
Mouna Akacha, Frank Bretz, David Ohlssen, Gerd Rosenkranz & Heinz Schmidli
Statistics in Biopharmaceutical Research, 2017
- A taxonomy of estimands for regulatory clinical trials with discontinuations
Thomas Permutt
Statistics in Medicine, 2015
- Estimands in clinical trials broadening the perspective [pdf]
Mouna Akacha, Frank Bretz, Stephen Ruberg
Statistics in Medicine, 2016
with Comments on Estimands in clinical trials broadening the perspective by
Thomas Permutt [pdf]
Peter Bauer [pdf]
Frank Rockhold [pdf]
- Editorial: Estimands in clinical trials - a challenge to intention to treat?
[pdf]
Simon Day, 2016