Sub-teams & Initiatives

Volunteer-driven working groups advancing innovative trial design methodology across therapeutic areas and disciplines.

Master Protocols KOL Lectures Randomization NEED AI/ML Basket Trials Oncology RWE StatBridge Initiatives

How Sub-teams Work

Each sub-team is a volunteer working group centered on a specific methodological or operational topic. Participation is entirely flexible, members may observe, contribute, take a leadership role, or propose a new sub-team at any time. The Leadership Team provides mentorship and consultation to anyone starting or stepping into a leadership role.

The IDSWG actively welcomes members from across the public health and drug development spectrum, including statisticians, clinicians, pharmacometricians, regulators, epidemiologists, health economists, ethicists, patient advocates, and clinical operations professionals. This interdisciplinary mix participates as full members across sub-teams and brings the range of perspectives needed to make innovative trial designs rigorous, practical, and relevant to the people they are meant to serve.

To join a sub-team or propose a new one, contact Bob, Mercedeh, or Alex, contact details are on the About page.

Active Sub-teams

Master Protocols (ASA-DahShu MPWG)

Chairs: Cindy Lu (AstraZeneca), Robert Beckman (Georgetown University)

A joint Working Group with the ASA and BSWG. Three active sub-streams: Concept & Methodology (Bryan McComb, Courtney Henry), Regulatory (Peter Mesenbrink, Julia Niewczas), and Implementation (Marianne Chase, Matthew Gribben). Currently producing a book, three manuscripts, and ongoing conference presentations on platform and master protocol design. The Concept, Methodology and Framework sub-stream is undergoing a reboot, new members are welcome.

Randomization

Chairs: Johannes Krisam (Boehringer), Kerstine Carter (Boehringer), Alex Sverdlov (Novartis)

Named PSI SIG of the Year in June 2025. Approximately 50 active and inactive members across pharma (19), academia (24), and other sectors (7), spanning EU/UK and USA. Hosts monthly member meetings and open learning sessions. Visit website

NEED, Rare Diseases

Co-leads: Qi Zhang (Sanofi), Daoyuan Shi (BlueRock Therapeutics)

Nature and Extent of Evidence Needed for Rare Diseases. Published three peer-reviewed papers since 2020 on historical controls, decentralized clinical trials, and cell and gene therapy. A manuscript on AI/ML for drug repurposing in rare diseases is currently in preparation with the AI/ML sub-team.

AI/Integrated Scientific Learning

Chair: Alex Sverdlov (Novartis)

Completed a book chapter on AI/ML in drug development for an upcoming Springer volume on cancer drug statistics. Actively collaborating with the NEED sub-team on a manuscript addressing AI/ML for drug repurposing in rare diseases.

Oncology

Chairs: Philip He (Daiichi Sankyo), Laura Fernandes (COTA)

Addresses innovative design questions specific to oncology drug development, including biomarker-driven designs and adaptive oncology trials.

Real-World Evidence (RWE)

Chair: James Chuo (Gilead)

Focused on the appropriate use of real-world data and evidence in clinical development, including external control arms and pragmatic trial designs.

Decision-Making

Co-leads: Zoran Antonijevic, George Wu

Quantitative and multidisciplinary approaches to decision-making in drug development, including portfolio optimization, go/no-go criteria, Bayesian decision analysis, and integration of innovative designs into development strategy.

StatBridge / Future Leaders Program

Chairs: Bryan McComb (Pfizer), Courtney Henry (GSK)

Bridges academic biostatistics and clinical practice by supporting early-career statisticians with mentorship, networking, and professional development. Learn more about the program

Ongoing Initiatives

Beyond the scientific sub-teams, IDSWG sponsors several broader organizational initiatives:

  • Special Issue, Therapeutic Advances in Rare Diseases, Bob Beckman, Zoran Antonijevic
  • Special Issue, Therapeutic Innovation and Regulatory Science, Philip He
  • Book Series (planned), Philip He
  • Newsletter (planned)
  • Joint Workshops with Patient Communities (planned)
  • Collaborations with EU Societies, including PSI (planned)

Volunteers are needed for several planned initiatives, reach out to the leadership team if you would like to contribute.

Patient Engagement Sub-team

The Patient Engagement sub-team, previously led by Deborah Collyar of Patient Advocates in Research (PAIR), is currently seeking a new leader.

Patient engagement is not a peripheral activity for the IDSWG, it is embedded in the group’s mission. Innovative trial designs should reduce patient burden, reflect what patients actually care about measuring, and be accessible to the populations who most need them. The Patient Engagement Sub-team works at the intersection of trial methodology and patient advocacy, ensuring that design innovation serves patients rather than simply optimizing operational or statistical metrics.

Activities have included joint workshops with patient communities, consultation on endpoint selection for rare disease trials, and contributions to the NEED Sub-team’s work on evidence standards for rare diseases.

If you are interested in leading this sub-team, please contact Mercedeh Ghadessi (asadahshuidswg@gmail.com).

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