The NEW ENGLAND JOURNAL of
STATISTICS in DATA SCIENCE

Call for Papers: Special Issue on Adaptive Designs and Multiple Testing Procedures — A Special Issue in Association with the ADMTP Workshop 2026

A Joint Special Issue of the Biomedical Research Section and the Cancer Research Section

Rationale

Modern clinical development is being reshaped by platform trials with multiple arms, seamless Phase I/II designs, master protocols embedding dose-optimisation objectives, and rising regulatory expectations around confirmatory inference. At the centre of this shift sits ICH E20, the new international guideline on adaptive clinical trials—a development that is redrawing the boundaries of accepted practice across the biopharmaceutical industry on both sides of the Atlantic.

The Adaptive Designs and Multiple Testing Procedures (ADMTP) Workshop is the annual forum of the joint working group of the German (DR) and Austrian-Swiss (ROeS) Regions of the International Biometric Society (IBS). ADMTP 2026 was held at Newcastle University, Newcastle upon Tyne, UK, from 1–3 June 2026, and brought together regulators, industry statisticians, and academic methodologists for 24 scientific talks, two keynote lectures, two pre-conference short courses, and a landmark panel discussion on ICH E20. The 2026 edition saw notably deeper US engagement than in previous years, reflecting the growing transatlantic reach of the workshop.

The New England Journal of Statistics in Data Science (NEJSDS)—the journal of the New England Statistical Society (NESS)—is pleased to announce a special issue dedicated to disseminating and extending the scientific contributions of ADMTP 2026. This special issue gives the workshop’s focused, cross-sector conversation a durable home within the US statistical community, while inviting contributions from the global adaptive-design and multiple-testing research community at large. Papers arising from workshop presentations will receive editorial priority; high-quality submissions from the wider biopharmaceutical statistics community are equally welcome.

Scope

We invite original research articles, methodological developments, review papers, perspective pieces, and case studies on topics including, but not limited to:

  • Platform trials, master protocols, and estimands under time trends and non-concurrent controls
  • Adaptive endpoint selection and modification in platform and confirmatory trials
  • Dynamic borrowing, external controls, and covariate-informed adaptive design
  • Anytime-valid inference using e-values and e-processes in confirmatory settings
  • Group sequential design, futility stopping, and interim monitoring under non-proportional hazards
  • The two-trials rule and its integration with adaptive and group sequential frameworks
  • Sample size and event re-estimation methods for time-to-event endpoints
  • Multiplicity adjustment, closed testing, and graph-based procedures for multiple endpoints
  • Reproducible and automated generation of multiplicity appendices and statistical analysis plans
  • ICH E20: implications and implementation, including connections to ICH E9(R1) and ICH E8(R1), and EU/US harmonisation
  • Dose optimisation and precision oncology designs, including Project Optimus–aligned methodology
  • Bayesian non-inferiority and umbrella-trial designs incorporating clinical belief
  • Algorithmic and simulation-based adaptive design, including simulated annealing and response-adaptive randomisation tuning
  • Adaptive designs for rare diseases, paediatric populations, and biomarker-stratified trials
  • Comparative perspectives on regulatory practice in adaptive designs across EU and US frameworks
  • Other topics related to adaptive clinical trial design and multiple testing procedures
Dedicated ICH E20 Section

A dedicated section of the issue will centre on the ADMTP 2026 panel discussion on ICH E20—chaired by Dr. Aritra Mukherjee (Newcastle University), with panellists Andrew Thomson (regulatory), Dr. Alex Sverdlov (Novartis, industry), Dr. Ayon Mukherjee (Eli Lilly, industry), and Dr. Sofia S. Villar (MRC Biostatistics Unit, Cambridge, academia)—and will include a synthesis paper with invited perspectives and worked case studies on ICH E20 implementation.

Timeline
  • Call for papers announced: July 2026
  • Submission portal opens: August 2026
  • Submission deadline: March 31, 2027
  • Expected publication: End of 2027
Submission

Manuscripts should be submitted through the NEJSDS online submission system at: https://www.e-publications.org/ness/sbs/

Please indicate in the Comments to Editors field that the submission is intended “For the Special Issue on Adaptive Designs and Multiple Testing Procedures (ADMTP).”

Authors of workshop-origin papers are encouraged to make use of NEJSDS’s Track II (author-led open review) option to accelerate dissemination, alongside the standard editor-led review track.

Guest Editors
  • Ayon Mukherjee, PhD (Chief Guest Editor) — Senior Research Associate, Newcastle University; Director, Biostatistics, Eli Lilly, United Kingdom
  • Satrajit Roychoudhury, PhD (Co-Guest Editor) — Executive Director, Statistical Research and Innovation, Pfizer, USA
  • Hongjian Zhu, PhD (Co-Guest Editor) — Global Head of Biostatistics and Data Science, SystImmune Inc., USA
  • Johannes Krisam, PhD (Co-Guest Editor) — Biostatistician, Boehringer Ingelheim, Germany
Coordinating NEJSDS Section Editors
  • Colin O. Wu, PhD — Editor, Biomedical Research Section, NEJSDS; National Institutes of Health, USA
  • Yuan Ji, PhD — Co-Editor, Cancer Research Section, NEJSDS; University of Chicago, USA
  • Ying Lu, PhD — Co-Editor, Cancer Research Section, NEJSDS; Stanford University, USA
Contact

For inquiries, please contact the guest editorial team:

In association with the ADMTP Workshop 2026, Newcastle upon Tyne, UK, June 1–3, 2026.

Full workshop programme: https://admtp.github.io/ADMTP2026/

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