Getting Started

Suggestions for Effective Collaboration Among Patient Advocacy Groups & Pharma

Value of Patient Advocacy Group/Pharma Collaboration Throughout Development

Research

Pre-Discovery

  • Learn about patients’ lived experience, diagnostic journey & burden of disease
  • Identify patient/care partner barriers & unmet needs
  • Understand access and experience with current treatments
  • Define research questions and outcomes relevant and important to patients
  • Define meaningful outcomes for the patient and healthcare community
  • Evaluate possibility of conducting a clinical trial in geographical region(s)

Pharma Contacts: Medical Affairs & Clinical Operations Study Lead
Patient Advocacy Group Contact: Leadership

Study Co-Design

  • Create research objectives based on prioritized unmet needs
  • Determine meaningful endpoints and patient-reported outcomes
  • Design patient-friendly informed consent
  • Define acceptable benefit-risk tradeoffs
  • Identify and co-design recruitment, retention, and patient engagement strategies
  • Incorporate what was learned in pre-discovery around pressing challenges (i.e., quality of life and access issues)
  • Strategize efforts to disseminate study findings – focused both in scientific and community avenues

Pharma Contacts: Medical Affairs & Clinical Operations Study Lead
Patient Advocacy Group Contact: Leadership

    Development

    Pre-Clinical

    • Provide spotlight on barriers to recruitment and participation
    • Organize clinical research education and awareness-building campaigns
    • Plan for drug administration and care delivery

    Pharma Contacts: Medical Affairs & Clinical Operations Study Lead
    Patient Advocacy Group Contact: Leadership

      Clinical

      • For each study phase, reference co-developed research strategy from Study Co-Design step when writing study concept and outline. Ensure study designs incorporate the meaningful endpoints that were discussed in earlier planning stages
      • Walk through proposed study procedures and drug administration with patients and health care providers to determine feasibility and level of comfort
      • Co-create patient-friendly educational materials
      • Work with trusted channels to raise awareness about clinical trials and support diverse patient participation
      • Select/recruit trial sites
      • Ask for patient perspective and overall satisfaction with clinical trial experience

      Pharma Contacts: Medical Affairs & Clinical Operations Study Lead
      Patient Advocacy Group Contact: Leadership

        Regulatory

        • Pharma to ensure patient input has been included in race & ethnicity diversity plans and in overall development program
        • Co-develop drug label language
        • Collaborate on FDA Patient Listening Sessions
        • Patient preference studies

        Pharma Contacts: Medical Affairs
        Patient Advocacy Group Contact: Leadership

          Commercialization

          Approval

          • Co-design patient education
          • Continue to break down barriers and misconceptions about research through multi-stakeholder awareness-building campaigns
          • Translate scientific research into publications, manuscripts and co-develop plain language versions

          Pharma Contacts: Medical Affairs & Public Affairs/ Patient Advocacy
          Patient Advocacy Group Contact: Leadership

            Post-Approval

            • Co-create and disseminate study results/plain language summaries
            • Collect real-world evidence and identify unmet needs
            • Create access strategies
            • Continue to address unmet needs and challenges
            • Collaborate on a long-term discovery and development strategy to improve treatment options and access
            Pharma Contacts: Medical Affairs, Public Affairs/Patient Advocacy, Commercial Marketing
            Patient Advocacy Group Contact: Leadership
            • Benchmarking Patient Recruitment and Retention Practices | TIRS 2020 Recruitment and Retention