Guidance

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 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…

By Lindsey, ago

Accelerating Clinical Trials: Best Practice for Recruitment and Retention

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…

By Lindsey, ago

MRCT Resources

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…

By Lindsey, ago

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 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…

By Lindsey, ago

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 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…

By Lindsey, ago

Guidance for Patient Involvement in Regulatory Processes

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…

By Lindsey, ago

How-to Guide on Patient Engagement in Clinical Trial Protocol Design

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…

By Lindsey, ago