About Us
Early phase clinical trials are the first stepping stone in the human stage of drug development. They are a critical stage of the pipeline, where statistical methodology should be used effectively to ensure safe and efficacious drugs are taken forward for further research. They comprise human studies of experimental treatments or combinations that follow pre-clinical testing until they are taken into confirmatory settings. These include first-in-human, dose-finding, dose-expansion cohorts, and proof-of-concept phase 1-2 trials, which focus primarily on generating safety and early efficacy data.
With a high proportion of treatments failing at phase 3, incurring very high costs (money, time, resources, participants), it is crucial that sufficient care is taken at that stage to ensure efforts are not wasted on substandard therapies. These trials are often highly adaptive and use Bayesian methods with limited sample sizes. Recently, in oncology, we have seen a paradigm shift in dose-finding trials with the FDA’s Project Optimus, rendering traditional designs obsolete.
The Early Phase ESIG was formed in 2026, bringing together statisticians with the aim of advancing the use of efficient methodologies within the early-phase trials community and fostering collaborations to ultimately reduce substandard treatments progressing to later phase trials.
Objectives
- Promote the use of innovative designs and statistical methodologies to improve standards within the early phase clinical trials community and reduce substandard treatments being taken into later phase trials.
- Improve understanding and implementation of methods within early phase trials via training, meetings and publications.
- Share knowledge and real-life experiences between key stakeholders in both academia and industry.
- Create space for collaboration, fostering a community of support rather than competition
Who we are
Sam Hinsley (Chair) and Marie-Karelle Riviere (Co-Chair) lead the Early Phase trials SIG. The full list of members as of May 2026 can be found below:
| Name | Affiliation | Name | Affiliation |
| Agnieszka Tomczyk | Paraxel | Karen Smith | UCB |
| Alexandra Jauhianen | AstraZeneca | Katya Mauff | GSK |
| Anaïs Andrillon | Saryga | Marie-Karelle Riviere (Co-Chair) | Saryga |
| Andrea Ford | Veramed | Matthew George | Phastar |
| Andrew Hall | Leeds Institute of Clinical Trials Research | Matt Chapman-Rounds | Cogitars UK Ltd |
| Anja Victor | Merck KGaA | Mike Sweeting | GSK |
| Ayon Mukherjee | Eli Lilly | Nicolas Sauvageot | Johnson & Johnson |
| Conor Norris | Cancer Research UK | Oliver Boix | Bayer |
| David Jegou | Pierre Fabre Medical Care | Pavel Mozgunov | MRC BSU |
| Donal Gorman | Pfizer | Roel Straetemans | J&J Innovative Medicine (Janssen) |
| Elli Bourmpaki | University College London | Sam Hinsley (Chair) | Phastar |
| Eslam Maher | Imperial College London | Sandrine Micallef | Debiopharm |
| Franck Poitiers | Sanofi | Stefan Klein | Bayer |
| Giulia Brunelli | Cogitars UK Ltd | Stephan Wojciekowski | Boehringer Ingelheim |
| Irina Garanina | ICON plc | Trevor Smart | UCB |
| István Németh | Parexel | Yalçın Yavuz | Centre for Human Drug Research (CHDR) |
| Jayne Marshall | AstraZeneca | | |
If you are interested in joining us and contributing, reach out to Sam (samantha.hinsley@phastar.com) or Marie-Karelle (marie-karelle.riviere@saryga.com).
Upcoming Events
We will be at the 11th EFSPI Regulatory Statistics Workshop in Basel, 19-20th August 2026. Look out for our poster!
Latest Achievements
Watch out this space for outputs from the Early Phase ESIG.