Comment from DaShu IDSWG Oncology Subteam

Summary: The Oncology / Immuno-Oncology subteam of the Innovative Design Scientific Working Group (IDSWG), representing several pharmaceutical companies and independent consultants, provides detailed technical feedback on the draft guidance. They request specific clarifications on trial definitions, statistical methodologies (such as adaptive randomization and multiplicity), and operational considerations like IRB structures and informed consent.