Presentation (CTI)

OBJECTIVES: Information requests dominate the most demanding phase of a Joint Clinical Assessment (JCA). Drawing on the first 18 months of experience, this analysis examined what actually triggers requests and how organisations can anticipate and manage them.
METHODS: A structured synthesis of first-wave practitioner experience examined the information requests encountered across complete oncology dossiers and contributed workstreams, the period between dossier submission and report endorsement, and the operational structures used to respond. Patterns were generalised and anonymised, and recurring request types were grouped by the assessor objective they served.
RESULTS: Requests most often turned on provenance and consistency rather than the underlying science: assessors could not see where a value originated, how an analysis was performed, or why a choice was made. Recurring requests mapped to a small set of assessor objectives — establishing whether the evidence is complete, valid, comparable, trustworthy, applicable, clinically meaningful, and independently verifiable. The submission-to-endorsement window proved the most operationally intense phase, requiring rapid generation of additional analyses, methodological justification, cross-functional coordination, and governance sign-off under tight timelines, for which routine project management was often insufficient. Organisations that anticipated likely requests and stood up a dedicated coordination structure — a JCA "war room" — responded faster and with fewer clarification cycles.
CONCLUSIONS: Most information requests are foreseeable and preventable. Pre-empting them through transparent, traceable packages — and resourcing a dedicated response structure for the submission-to-endorsement window — compresses timelines and reduces strain on sponsor and assessor alike.