Patient-Focused Drug Development

What in the drug development process is most important to patients? The new FDA draft guidance on Patient-Focused Drug Development released September 30, 2019, provides quantitative and qualitative methods for sponsors to measure a patient’s experience with respect to disease burden and treatment. FDA invites comments until the end of the year.

Want to dig deeper into patient-focused drug development?

  • Article

    Assessing Biopharmaceutical Company Experience with Patient-Centric Initiatives
    Clinical Therapeutics
    Debra L. Michaels, Mary Jo Lamberti, Yaritza Pena, Barbara Lopez Kunz, Kenneth Getz

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  • Article

    Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development
    Stella Stergiopoulos, Debra L. Michaels, Barbara Lopez Kunz, Kenneth Getz
    Therapeutic Innovation & Regulatory Science
    Member-only contentMember-only content

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  • Article

    Dear Sponsor: The Patient Will See You Now – Tipping Point in Clinical Research
    Roslyn Schneider, Richard Stephens, Tony Hoos, Lode Dewulf
    Global Forum

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  • Article

    Role of Patients and Parents in Pediatric Drug Development
    Vivian W. L. Tsang et al.
    Therapeutic Innovation & Regulatory Science
    Member-only contentMember-only content

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  • Podcast

    The Patient's Most Engaging Question: Why?
    Deborah Collyar, Lode Dewulf

    Listen Now

  • Article

    Mapping the Landscape of Patient-Centric Activities Within Clinical Research
    Mary Jo Lamberti, Josephine Awatin
    Clinical Therapeutics

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  • Article

    Pharmacovigilance: Towards 2020 and Beyond
    Chris M. Slawecki
    Global Forum

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  • Article

    The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream
    Matthew Reaney et al.
    Therapeutic Innovation & Regulatory Science
    Member-only contentMember-only content

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  • Article

    Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program
    Wendy Selig, Ian Banks, Anjelica Davis, Gissoo DeCotiis, Ryan Hohman, Lisa Schlager
    Therapeutic Innovation & Regulatory Science
    Member-only contentMember-only content

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Want to learn more?

Check out INSIDER ACCESS: Making Clinical Trials Work for Special Populations – our exclusive content for DIA Members. A full-length transcript is also available. Or download DIA's Considerations Guide to Implementing Patient-Centric Initiatives in Healthcare Product Development and DIA's Patient Engagement Study Findings from our Collaboration with the Tufts Center for the Study of Drug Development (CSDD).

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  • Article

    From RAPS: Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

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  • Article

    From FDA: FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

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