Ensure all follow-up is costed
Consider up front how to ensure there is adequate resource to support all trial follow-up activity (see principle D1).
This should include follow-up activity for participants whose participation changes during their time on trial, and those who ‘complete’ all aspects of participation.
Support flexibility in follow-up arrangements
Planned costs should include supporting any alternative follow-up arrangements that could allow participants to continue taking part but with less commitment (see Protocol Development).
Such alternative arrangements should be designed with the help of patient contributors, who can help ensure the planned trial is as burden-free as possible for its participants.
More research may be needed on the cost implications of different sorts of follow-up schedules and methods.
Use data to inform planning
Decisions made in grant development should be informed by available data on trials with similar designs, similar interventions, similar participant populations or conducted in similar settings. This will give an indication of the expected frequency and nature of participation changes in the new trial.
Data about prior trials should also inform any sample size ‘inflation’ done to ensure there would still be sufficient statistical power after any participation changes.
Consider other costs
Any specific mechanisms to try to regain contact with, or collect further data about, participants who have lost contact with trial staff (see principle O4) should also be fully costed.
Costing should also include adequate funds to support all activity intended to help manage participation changes, including work on any relevant computer systems or to deliver training.
Resourcing requirements can be a barrier to sharing trial results with the trial’s participants. If the nature of the trial means it might require more resource to share results with participants who stop or reduce their participation, consider this in the trial costing.