The client needed assistance recruiting patients for a phase I/II trial in a disease area with many other simultaneously ongoing clinical trials

Case: Co-Creating Clinical Trial Design & Recruitment Strategy
Situation
The client needs to obtain the patient view and preferences on clinical trial design, especially in regard to the burden of the trial, in- and exclusion criteria and readability of consent material. The client had not previously involved patients in clinical trial design and had no structure and procedures in place for gathering patient feedback.

Our Solution
- Patient representatives with HTA experience to review the target product profile of the clients’ asset
- Full review of the development plan and trial design in regard to patient relevance
- Gap analysis emphasizing patient-relevant aspects
- Discuss and challenge recruitment & retention strategy
- Joint session with the client’s internal team to discuss findings
Results
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Highly patient-relevant trial design in regard to HTA and clinical outcomes and capturing patient needs and preferences for efficient recruiting and retention