Table 2.

Recommendations for ICI optimisation trials.

	Recommendation
All	Patient perspectives should be sought to help plan trial design/communication to improve recruitment strategies.
	Consider implementation of a qualitative sub study to investigate reasons why participants accepted or declined trial participation to refine trial recruitment strategies in a timely manner.
Trial design (all)	During trial development consider whether a personalised approach could be implemented (e.g. through therapeutic drug monitoring).
	Eligibility criteria should allow for inclusion of participants who have experienced toxicity, as these participants are often more motivated to participate.
	Consider whether it is possible for participants to revert to SOC if their cancer progresses.
Trial design of extended interval & early cessation trials	Ensure non-treatment monitoring visits are built into the trial protocol (remote monitoring is acceptable).
Trial design of early cessation trials	Consider offering additional psychological support if the participant stops treatment.
Communication	Include an appropriately pitched summary of the scientific rationale for ICI optimisation (including an explanation that research has demonstrated that there is not the same dose-effect relationship we see with other treatments).
	Clearly communicate both verbally and in the patient information sheet that participants on the experimental ‘optimised’ treatment schedules can revert to SOC if their cancer progresses.
	Highlight the trial visit schedule is not reduced despite fewer treatment visits and ensure patients have adequate opportunities to discuss any concerns with their clinical team.
	Provide general information on the role and nature of clinical trials to address the misconception of trials as a last resort.