The client needs to obtain the patient view and preferences on clinical trial design, especially regarding the burden of the trial, in- and exclusion criteria and the readability of consent material. The client had not previously involved patients in clinical trial design and has no structure and procedures in place for gathering patient feedback.
Patient representatives with HTA experience review the target product profile of the clients’ asset
Full review of the development plan and trial design regarding patient relevance
Gap analysis emphasizing patient-relevant aspects
Highly patient-relevant trial design regarding HTA and clinical outcomes and capturing patient needs and preferences for efficient recruiting and retention