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Table 3 Trial conduct: lessons learned on adding a new research comparison to an ongoing platform

From: This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Area Lesson learned
Research question Define criteria for review of new research comparison
Trial Management Group Collaborative Group
Chief Investigator: overall trial oversight
Co-CI: clinical and scientific leadership for addition of new research comparison
Scientific peer review Ongoing discussion with key funding stakeholders
Planning for adequate support of central resources
Addition of new comparison discussed in early stages to assess feasibility of funding
Biomarker development Clearly define cohort and identify biomarkers
Early feasibility assessment for site implementation
Protocol development Consider protocol structure to futureproof changes in trial design (e.g. modular vs single protocol)
Ethics and regulatory approval Rationale for addition of new comparison discussed early with regulatory bodies to prepare for submission
Change of governance and regulatory framework
CRF and database development Timelines for implementing changes are key for timely implementation
Site implementation Engage early (e.g. via survey or Q&A) to gauge interest in new research question
Discuss activation criteria with centres as early as possible
Pre-set timelines for local approval of new comparison (if control arm is shared)
Other Constant assessment of priorities and competing tasks
Importance of adequate resourcing of central trial management team
Consider recruitment rate to plan for post-launch activities (e.g. pre-planned interim analyses)