The IDSWG held its annual face-to-face meeting on September 24, 2025, bringing together members from across the group’s sub-teams and initiatives.

The evening opened with welcome remarks from Chair Bob Beckman, followed by introductory presentations on the IDSWG, DahShu, and collaboration opportunities with the Bayesian Scientific Working Group (BSWG). Bryan McComb presented the StatBridge Future Leaders Program, highlighting the initiative’s goals and upcoming activities.

Sub-team reports covered the Master Protocol Working Group (Concept, Methodology and Framework; Regulatory), the Randomization Working Group, the AI/ML Sub-team, the NEED Sub-team for Rare Diseases, and the KOL Lecture Series.

Key updates from the meeting:

• The Concept, Methodology and Framework sub-stream of the MPWG is undergoing a reboot under new leadership from Bryan McComb and Courtney Henry. New members are welcome.
• The Regulatory Sub-team is seeking volunteers to support the 2020–2025 Systematic Literature Review update.
• Two leadership positions remain open for the 2025–2026 term, nominations are welcome.

The next annual meeting date will be announced via the DahShu community. Subscribe to receive updates.

Robert A. Beckman (Chair, DahShu IDSWG; Georgetown University) presented an introduction to the IDSWG at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (RISW 2025) on September 21, 2025.

The presentation covered the IDSWG’s vision and leadership structure, opportunities for members, current sub-team and initiative updates, and selected past work, including the 2020 Complex Innovative Design (CID) Conference, recent ISBS activity, the Master Protocol book project, and the Rare Disease book project with Ray Huml.

The slide deck is available for download below.

Download: IDSWG Introduction, RISW 2025 (PPTX)

Topics covered:

• IDSWG vision, mission, and membership (~200 members from pharma, biotech, academia, and health authorities in the US, Europe, and Japan)
• Leadership team introductions (Beckman, Ghadessi, Sverdlov)
• Sub-team structure and current chairs
• StatBridge Future Leaders Program
• ASA-DahShu MPWG updates, book nearing completion, three manuscripts in preparation
• Basket Trials, RWE, Oncology, NEED, AI/Integrated Scientific Learning, Randomization sub-team reports
• Planned initiatives: newsletter, website, book series, joint patient community workshops, EU society collaborations

For questions about the IDSWG, contact Bob Beckman, Mercedeh Ghadessi, or Alex Sverdlov.

The IDSWG Randomization Working Group has been named PSI Special Interest Group of the Year for 2025, a recognition of its sustained contributions to randomization methodology in clinical trials.

The Randomization WG is co-chaired by Johannes Krisam and Kerstine Carter (both Boehringer Ingelheim) and Alex Sverdlov (Novartis). The group currently has approximately 50 active and inactive members spanning pharmaceutical industry (19), academia (24), and other organizations (7), with representation across Europe/UK and the USA.

The WG’s work focuses on moving beyond standard permuted-block randomization to bring awareness of modern methodological advances in the field. Activities include monthly member meetings, open learning sessions, a dedicated website, and a growing library of publications, slide sets, and educational resources.

Congratulations to the Randomization WG team on this well-deserved recognition.

The NEED Sub-team’s latest paper has been published in Therapeutic Innovation & Regulatory Science:

Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases, by DahShu Innovative Design Scientific Working Group (IDSWG)

This paper represents the third major publication from the NEED (Nature and Extent of Evidence Needed for Rare Diseases) Sub-team, co-led by Mercedeh Ghadessi (Bayer) and Sammi Tang (Astellas). It follows earlier publications on historical controls (2020) and decentralized clinical trials (2023).

The paper addresses clinical development considerations specific to cell and gene therapy in rare disease settings, covering design approaches, regulatory landscape, and operational challenges.

Read the paper, doi:10.1007/s43441-025-00853-4

The Master Protocol Working Group has published a new paper in Therapeutic Innovation and Regulatory Science:

Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews Wu, Y., Lu, C., Aregay, M. et al.

This paper reports findings from cross-industry interviews examining the design, operational, and strategic challenges of company-sponsored platform trials. It offers practical recommendations for organizations considering this trial structure.

The MPWG is a joint working group co-chaired by Cindy Lu (AstraZeneca) and Robert Beckman (Georgetown University), operating under the ASA, DahShu IDSWG, and BSWG umbrella.

Read the paper, doi:10.1007/s43441-025-00792-0