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) |