Early Phase ESIG

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:

NameAffiliationNameAffiliation
Agnieszka TomczykParaxelKaren SmithUCB
Alexandra JauhianenAstraZenecaKatya MauffGSK
Anaïs AndrillonSarygaMarie-Karelle Riviere (Co-Chair)Saryga
Andrea FordVeramedMatthew GeorgePhastar
Andrew HallLeeds Institute of Clinical Trials ResearchMatt Chapman-RoundsCogitars UK Ltd
Anja VictorMerck KGaAMike SweetingGSK
Ayon MukherjeeEli LillyNicolas SauvageotJohnson & Johnson
Conor NorrisCancer Research UKOliver BoixBayer
David JegouPierre Fabre Medical CarePavel MozgunovMRC BSU
Donal GormanPfizerRoel StraetemansJ&J Innovative Medicine (Janssen)
Elli BourmpakiUniversity College LondonSam Hinsley (Chair)Phastar
Eslam MaherImperial College LondonSandrine MicallefDebiopharm
Franck PoitiersSanofiStefan KleinBayer
Giulia BrunelliCogitars UK LtdStephan WojciekowskiBoehringer Ingelheim
Irina GaraninaICON plcTrevor SmartUCB
István NémethParexelYalçın YavuzCentre for Human Drug Research (CHDR)
Jayne MarshallAstraZeneca  

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.

 

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