Case: Patient Dialogue about Patient Pathway to Assist Clinical Trial Recruitment

Situation

The client is beginning to design a clinical trial protocol for a new phase I/II trial in a poorly understood, under-diagnosed, and rare genetic disorder with no other current treatments. There are only about 50 families affected by the condition in Europe without a formal patient association. In order to meet enrolment targets, the client will have to make a compelling case on the value of their treatment to families and establish trust.

 

The client needs to understand the needs, challenges, everyday life, preferences and hopes for the future of families affected by this genetic disease. The client’s compliance department felt it was best for the interviews to be done by an outside entity.

 

Our Solution

  1. Designing a qualitative interview guide, co-created by patients and aligned with the client’s needs
  2. Setting up a quantitative screening survey for an appropriate recruitment process
  3. Conducting exploratory semi-structured interviews with patients and with other stakeholders like KOLs, HCPs, caregivers, etc. when deemed necessary
  4. Visualization of the patient pathway

Results

  • Obtaining important insights into the patient pathway and detection of relevant health care gaps

Multi-Stakeholder Co-Creation on Real-World Evidence

A client wishes to submit an HTA dossier to a payer institution for a therapeutic indication with many other approved treatments already existing on the market

Co-Creating Clinical Trial Design and Recruitment Strategy

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

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