Patient-Focused Medical Product Development Webinar Series
The NHC’s Patient-Focused Medical Product Development series builds upon our Clinical Outcome Assessment (COA) series, which we hosted between Nov. 2018-Dec. 2019. The series will continue to introduce COA-related topics, but also will cover a broader range of subjects, including patient preference research, patient engagement in clinical trial design, as well as medical device development. The NHC seeks to ensure that the NHC membership is prepared to engage in conversations on all aspects of PFMPD. It is complementary to our other workstreams, including our Case Examples, Patient Engagement Compensation and Contracting Toolbox, and Rubric to Capture the Patient Voice.
About Patient-Focused Medical Product Development
Patient-focused medical product development is a mechanism by which stakeholders, including but not limited to medical product developers, academics, and regulators, form a partnership with patients to enhance medical product development, throughout the research, regulatory, and reimbursement processes. It is built on the belief that:
- understanding patient experiences, goals, and needs leads to clinical trials that are more efficient and that measure outcomes patients really care about;
- more successful medical product development because potential barriers to uptake were identified and addressed earlier;
- and value/health technology assessment that evaluate drugs based on patient-defined value.
FDA’s Patient-Focused Drug Development Initiative
The Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative began under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Originally, FDA’s PFDD initiative referred to a series of disease-specific meetings hosted by the FDA. Following each of these meetings, FDA published a Voice of the Patient summary report. Subsequently, a process was established for patient organizations to host their own PFDD meetings (see Externally-led PFDD). Under PDUFA VI, FDA committed to developing four guidances on PFDD. For the most up-to-date information, please visit the FDA’s PFDD website.
PFMPD Webinar Recordings
- What Are Patient-Centered Outcomes and Why Aren’t All Health Outcomes Considered “Patient Centered”?
- Optimizing Digital Health Trials by Engaging Patients and Sites
- Health Literacy Throughout Drug Development: Why it Matters to Pharma and to Patients
- Patient-Focused Medical Product Development: Real-World Case Examples
- What is the Role of Patient-Reported Data in Outcomes-Based Contracts?
- Observer-reported or Proxy-reported: Is One Better than the Other?
- A Look at Rare Disease Listening Sessions with NORD and the FDA
- Patient Reported Outcomes and Patient Centered Outcomes
- FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials
- Untangling the Terms: Endpoints, Items, Outcomes, PRO’s, PROMs, PRO-PMs
- Successful COAs: It All Starts With the “Concept of Interest” and “Context of Use”
- What Do We Mean by Validation of a Measure?
- Measuring Patient Experiences: Distinguishing Between Patient-Reported Outcomes and Patient Preferences
- Lessons Learned from a Patient Group’s Experience Developing a PRO
- What is the Difference Between Health-Related Quality of Life (HRQoL) and Patient-Reported Outcomes?
- Core Outcome Sets
- What are Clinician-Reported Outcomes (ClinROs)?
- Clinical Outcome Assessment: Build New or Adapt Old?
- 21st Century Cures: Requirement on Patient Experience Data and Related Information
If you would like to suggest a topic for a future webinar, please submit one below.