Table 3.

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

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)