Table 2 Issues we faced while designing CHARIOT and suggestions on how to deal with them, based on what we have learnt and wished we knew before starting the trial design
From: Challenges in implementing model-based phase I designs in a grant-funded clinical trials unit
Area | Issue | What to do |
|---|---|---|
Software | All trial details must be programmed | Use existing software to get as close as possible |
Funding | A great deal of statistical input is required before the grant is awarded | − This issue is more pronounced for the first few model-based trials that a clinical trials unit undertakes. Once the process is well-known, code will be in place and templates will have been designed for text in the protocol and statistical analysis plan − Consider stating the design without much detail in the grant application. Leave some aspects of the design to be refined within the grant, during trial set-up |
Data management | Trial requires fast (e.g., within 24 hours) and accurate data entry | − Have required data collated on a single case report form − Accept data during teleconferences (as is done in 3 + 3 designs) and run the model during the teleconference − Classify all dose-limiting toxicities as serious adverse events to ensure prompt reporting |
Statistical knowledge | − Trial statisticians need to check they have made good decisions − Enhance trial statistician learning | – MAST (UK-based) – Consult colleagues with experience in such designs through a registered clinical trials unit network |