Alongside policies and standard operating procedures, CTU staff can receive specific training on preparing for and managing participation changes.
This will give them more confidence in managing what can sometimes be a challenging area, and is an important way to address PeRSEVERE principle D6.
Training can further increase the likelihood that staff will follow best practice in their day-to-day work.
Training for CTU staff could link with, or run alongside, standard Good Clinical Practice training.
Suggested training content about managing participation changes
Training might include:
- The fundamental principles guiding participation changes and withdrawal of consent, including those in PeRSEVERE and the supporting ideas in Good Clinical Practice.
- Participants’ ‘right to withdraw consent’ as presented in ethical guidance about clinical trials, and the need for individuals’ rights to take precedence of those of science and society (as per Good Clinical Practice)
- The ‘balance’ to be struck between changing participation in line with participants’ wishes (see principle O2 – participants decide how their participation changes) while ensuring processes aimed at establishing participants’ wishes do not prevent participants stopping any aspects of participation that they want to stop.
- The need for everyone involved in trials (in any capacity) to understand the potential complexity around participation changes and to use language and terminology to match (see principle O1 – participation can stop, reduce or change).
- The value of collecting as much of the planned data as possible, particularly in relation to primary outcome data (see principle O3 – the more data, the better).
- That the features of each trial need to be taken into account when considering participation changes, and the sorts of decisions that need to be made in trial design and protocol development.
- Actions expected from CTU staff and others (e.g. trial site staff) when managing different types of participation change. This includes where participants express a wish to stop, change or reduce their participation, where intervention stops primarily due to decisions by people other than the participant, and where participants and trial staff lose contact with one another.
- What a ‘presumed ongoing consent’* approach is, when it can be appropriate to apply it, and what associated conditions need to be met in order to apply it (see principle O5 – continuing data collection).
- Guidance on what to do in more complex cases, for example involving changes to participants’ health or capacity to consent, or situations where participants’ wishes about specific aspects of participation are not known.
* This means participants’ consent to a particular trial activity is presumed to be ongoing if the participant has not said they want that activity to stop, as long as certain conditions are met. For more details, see PeRSEVERE principle O5.
Note that some of the guidance about training for trial sites may also apply where the CTU is recruiting trial participants directly (i.e. where there are no trial sites).
Other training opportunities
Statistical staff (and potentially others within the trial team) should have training and opportunities to learn about evolving best practice in handling missing data in trial analyses, including defining and using estimands (see principle R1 – analysing studies with participation changes).
Other training can reinforce the PeRSEVERE principles. For example, data protection training will emphasise the importance of not collecting more data than required for a specific purpose (see principle D1 – protecting study integrity by design), and explain that exemptions to data subjects’ rights given in UK and EU data protection law allow for research data to be retained once already collected (see principle O6 – retaining data).
There should also be ways for staff to learn from one another, share good practice and ask questions about the best approach for general and specific issues in handling participation changes.
Tools, templates and checklists can be developed to make it easier for staff to follow the Standard Operating Procedures and all other best practice guidance.