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 TomczykParaxelJayne MarshallAstraZeneca
Alexandra JauhianenAstraZenecaKatya MauffGSK
Anaïs AndrillonSarygaMarie-Karelle Riviere (Co-Chair)Saryga
Andrea FordVeramedMatt Chapman-Rounds Cogitars UK Ltd
Andrew HallLeeds Institute of Clinical Trials ResearchMike SweetingGSK
Anja VictorMerck KGaA Nicolas Sauvageot Johnson & Johnson
David JegouPierre Fabre Medical Care Oliver BoixBayer
Donal GormanPfizerPavel MozgunovMRC BSU
Elli BourmpakiUniversity College LondonRoel StraetemansJ&J Innovative Medicine (Janssen)
Eslam MaherImperial College LondonSam Hinsley (Chair)Phastar
Franck Poitiers Sanofi Sandrine MicallefDebiopharm
Giulia BrunelliCogitars UK LtdStefan KleinBayer
Irina Garanina
ICON plc Trevor SmartUCB
István NémethParexelYalçın YavuzCentre for Human Drug Research (CHDR)

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 PSI 2026 Conference, taking place from 15th - 17th June, with a session titled: “Developments in early phase dose-finding trials,” covering:

  • Introduction to the new early phase ESIG – Sam Hinsley
  • Recent advances in dose-finding: an introduction – Pavel Mozgunov
  • Designing phase I trials with backfilling to mitigate screening and treatment delays – Andrew Hall
  • A novel method for inserting dose levels mid-trial in early phase combination studies – Matt George
  • U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization based on Dose-Exposure, Safety, Pharmacodynamics, Efficacy in early-phase oncology trials – Anaïs Andrillón & Sandrine Micallef

In addition, Giulia Brunelli has a talk on: BOIN vs. BLRM: a systematic performance comparison in phase 1 dose escalation.

Look out for us in the LOUNGE!

Latest Achievements

Watch out this space for outputs from the Early Phase ESIG.

 

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