AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
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 | Statclarity |
| Maxine Bennett | AstraZeneca |
| George Hawkins | AstraZeneca |
| Aaron Dane | DaneStat |
| Arthur Allignol | Merck |
| Sophie Barthel | PRA Health Sciences |
| Martin Posch | Medical University of Vienna |
| Toshimitsu Hamasaki | George Washington University |
| Michael Zhang | Autolus |
| Foteini Strimenopoulou | UCB |
| Olivier Collignon | GSK |
| Julia Niewczas | Johnson & Johnson |
| Fang Chen | SAS |
| Satrajit Roychoudhury | Pfizer |
| Rajat Mukherjee | Alira Health |
| Martin Bøg | Novo Nordisk |
| Martin Kappler | Cytel |
| Marie-Laure Casadebaig | Incyte |
Contact: Nicky Best (GSK) or Simon Wandel (Novartis)
Email: nicky.x.best@gsk.com or simon.wandel@novartis.com
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| Event | Topic | Material |
| PSI 2022 conference | A framework for evaluation of Bayesian Dynamic Borrowing designs in pivotal studies | |
| ... | ... | ... |