Letter to Patients Inviting Participation in an Advisory Panel Letter to Patients Inviting Participation in an Advisory Panel | Sample Shared by PALADIN Member Example of a letter that sponsors can use to invite patients to participate on an advisory board. Download Here
Sponsor Letter to PAG Inviting Collaboration Sponsor Letter to PAG Inviting Collaboration | Sample Shared by PALADIN Member Example of a letter that sponsors can use to invite patient advocacy groups to collaborate. Download Here
Advisory Board Meeting Agreement between Industry and PAG Template Advisory Board Meeting Agreement between Industry and PAG Template | Template Shared by PALADIN Member Template with contact language for individuals who participate in an advisory board with language for confidentiality, data privacy, reporting, and compensation. Download Here
FDA Guidance on Engaging Community and Advocates in Diversity Guidance on Engaging Community and Advocates in Diversity | FDA This FDA guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in Read more…
Patient Advisory Board Agreement Template Patient Advisory Board Agreement Template | Template Shared by PALADIN Member Template with contact language for individuals who participate or serves on an advisory board with language for confidentiality, data privacy, reporting, and compensation. Download Here
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use | ICH ICH unites global regulators and the pharmaceutical industry to develop guidelines for safe, effective medicines. Established in 1990, it has grown to include 21 Read more…
Regulations: Good Clinical Practice and Clinical Trials Regulations: Good Clinical Practice and Clinical Trials | FDA Links to current FDA Good Clinical Practice regulations governing human subject protection and the conduct of clinical trials. These materials contributed significantly to the development of the rules governing these crucial aspects of healthcare Read more…
Innovative Health Initiative Project Factsheets IHI Project Factsheets | IHI Project from IHI, an EU public-private partnership funding health research and innovation. View Here
Innovative Health Initiative Innovative Health Initiative | IHI Information on IHI, an EU public-private partnership funding health research and innovation. View Here
International Conference for Harmonization (ICH) reflection paper on Patient Focused Drug Development International Conference for Harmonization (ICH) reflection paper on Patient Focused Drug Development | ICH Collection of reflection papers with linked patient-focused drug development. View Here
Patient Centered Outcomes Research Institute Patient Centered Outcomes Research Institute | PCORI Information on Patient Centered Outcomes Research Institute (PCORI). View Here
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…
Patient Engagement in Early Dialogues: Tools and Resources for HTA Bodies Patient Engagement in Early Dialogues: Tools and Resources for HTA bodies | IHI (formerly IMI) PARADIGM Downloadable toolkit for HTA bodies. This resource contains three main sections covering the rationale for engaging and involving patients in Early Dialogues, an Read more…