Many approaches for designing and analyzing clinical trials using historical (or other external study) data have been proposed in the recent past. For example, proposals have been made for bridging studies, the combination of randomized and non-randomized evidence, and also for more general problems such as across-phases probability of success calculations. In addition, the ever-increasing number of patient registries and databases for routinely collected data, and recent data sharing initiatives (e.g., TransCelerate), further underline the importance of these approaches. However, there are still many open questions concerning the role which clinical trials that use such data can have in drug development. In our opinion, the three most important questions are:
The scope of this SIG is to provide some answers to the above questions through a variety of activities. These will include:
| Name | Company/Institution |
| Nicky Best (co-lead) | GSK |
| Simon Wandel (co-lead) | Novartis |
| Gaelle Saint-Hilary | Servier |
| Lisa Hampson | Novartis |
| Sebastian Weber | Novartis |
| Oliver Sailer | Boehringer Ingelheim |
| Nelson Kinnersley | Octa Consulting |
| David Dejardin | Roche |
| Ros Walley | UCB |
| Maxine Bennett | AstraZeneca |
| George Hawkins | AstraZeneca |
| Christian Roever | Universitat Gottingen |
| Aaron Dane | DaneStat |
| Arthur Allignol | Merck |
| Arijit Sinha | Roche |
| Sophie Barthel | PRA Health Sciences |
| Martin Posch | Medical University of Vienna |
| Toshimitsu Hamasaki | George Washington University |
| Michael Zhang | Autolus |
Contact: Nicky Best (GSK) or Simon Wandel (Novartis)
Email: nicky.x.best@gsk.com or simon.wandel@novartis.com
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