Table 1.

Questions to be addressed when reporting cell and gene therapy clinical trials.

1	Population	What was the condition (or set of conditions and variant definitions) of interest? What were the inclusion/exclusion criteria for recruitment? What were the baseline characteristics of trial participants?
2	Sampling	How were patients identified and selected for the trial? Do the included patients reflect a convenience sample or random sample of the broader patient population?
3	Outcome	What were the primary endpoints of the study? Why were these particular endpoints chosen? How do the chosen outcomes align with the study aims and objectives?
4	Intervention	What interventions were studied (including dose, schedule, manufacturing parameters, co-interventions, etc.)?
5	Randomization	Was there a suitable control group, making it ethical to randomly assign subjects to either control or experimental arms? If not, what other steps were taken ensure valid results were obtained?
6	Analysis	What was the pre-specified hypothesis and analysis plan? How was missing data handled?
7	Adverse events	What were the clinical characteristics—e.g., severity, frequency, and timing—for all recorded adverse events?
8	Setting	How do characteristics of the trial setting—e.g., readiness of the trial unit and level of training of healthcare professionals—impact the clinical outcome of these interventions?