Table 2 Recommendations for ICI optimisation trials.
From: Hit it hard: qualitative patient perspectives on the optimisation of immune checkpoint inhibition
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. |
