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

  1. Patient representatives with HTA experience to review the target product profile of the clients’ asset
  2. Full review of the development plan and trial design in regard to patient relevance
  3. Gap analysis emphasizing patient-relevant aspects
  4. Discuss and challenge recruitment & retention strategy
  5. Joint session with the client’s internal team to discuss findings

Results

  • Highly patient-relevant trial design in regard to HTA and clinical outcomes and capturing patient needs and preferences for efficient recruiting and retention

Enhancing Clinical Trial Recruitment

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

Developing a Patient Advisory Board

The client would like to establish a European patient advisory board to guide upcoming clinical trials, act as a sounding board to hear patient concerns firsthand and get regular advice from patient advocates on a variety of topics in R&D

Co-creating a Patient Support Program

A company is developing a new medical product for patients with a rare disease. Additional services, e.g. a patient-support-program (PSP), are considered important to help patients gaining access to new treatments when needed