Co-Create Design & Delivery

Opportunity

Patients are experts in their condition and should inform clinical development. Patient / care partner input early on during the study design and protocol development can help improve patient experience in clinical trials, reduce patient burden, and increase recruitment, retention, and enrollment rates.

Considerations to Help Action the Opportunity

• Define internal sponsor processes to support patient / care partner engagement early in drug development, including budgetary requirements, contracts, IRB / ethics review, legal and data privacy issues, etc.
• Develop an engagement strategy early in the drug development process outlining the plan for identification of representative samples of patients, engagement method(s), timing of engagement(s), data utilization, sharing, assessment, etc.
• Understand investigator / clinical site perspective (in addition to patient / care partner input) of processes, investments and working practices
• Develop robust communication strategy to share information back to patients / care partners about how feedback influenced protocol design / other study elements and justification for when it was not used
• Understand patients / care partners input on the operational difficulties and the options for patients / care partners that can be included in trial design to overcome these
• Establish early partnerships among patients, sponsors, and investigators / clinical sites to build commitment for ongoing sharing of information

Value and Potential Benefits

• Improves patients’ clinical trial experience, reduces patient burden, and increases enrollment rates through patient-centric study design
• Establishes early connection between patients / participants and clinical development program, product / brand and company
• Improves the representation of diverse patient populations in clinical trials via tailored solutions and focused investments