Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data | FDA An overview of patient experience data draft guidance. View Here
FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making | FDA A four-part series of Read more…
Accelerating Clinical Trials: Best Practice for Recruitment and Retention Accelerating Clinical Trials: Best Practice for Recruitment and Retention | MJFF “This guide adopts the participant journey as a framework to enhance the design of clinical trials. Beginning with recruitment and extending through post-trial follow-up, participants willingly embark on a pathway Read more…
MRCT Resources MRCT Resources| MRCT Center of Brigham and Women’s Hospital and Harvard “MRCT Center resources include case studies, framework and guidance documents, meeting summaries and webinar recordings, presentations, publications, and more.Information on the MRCT (Multi-Regional Clinical Trials) Center at Brigham and Women’s Hospital with four primary areas of focus Read more…
Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation | PFMD “A practical guide for collaborative development of plain language summaries (PLS) for peer-reviewed publications and conference Read more…
Working with Community Advisory Boards: Guidance and Tools for Patient Communities and Pharmaceutical Companies Working with Community Advisory Boards: Guidance and Tools for Patient Communities and Pharmaceutical Companies | IHI (formerly IMI) PARADIGM A toolkit encompassing guidance and resources related to community and patient advocacy in the healthcare industry. View Read more…
Patient Listening Sessions Patient Listening Sessions | FDA These sessions are a resource for the medical product Centers to engage with patients and their advocates. Patient Listening Sessions are one of many ways the patient and advocacy community can share their experiences and perspectives by talking directly with FDA staff. Read more…
Guidance for Patient Involvement in Regulatory Processes Guidance for Patient Involvement in Regulatory Processes | EUPATI “This guidance for PAGs covers patient involvement in the regulatory field and draws on the mature “Framework for interaction between the European Medicines Agency and patients and consumers and their organisations” “”Guidance for patient Read more…
How-to Guide on Patient Engagement in Clinical Trial Protocol Design How-to Guide on Patient Engagement in Clinical Trial Protocol Design | PFMD “PFMD: The guide will give more clarity, instructions and the key terminology to Patients, Carers, Patient Organizations, Industry (Pharma, Biotech, Devices), Academia, Researchers, Contract Research Organisations (CROs) on Read more…