Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience Condition-Specific Meeting Reports and Other Information Related to Patients’ Experience | FDA A collection of condition-specific meeting reports from FDA Patient Listening Sessions. View Here
Enhancing Benefit-Risk Assessment in Regulator Decision-Making Enhancing Benefit-Risk Assessment in Regulatory Decision-Making | FDA An FDA guidance intended to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Agency makes about Read more…
Assessment of the Use of Patient Experience Data in Regulatory Decision-Making Assessment of the Use of Patient Experience Data in Regulatory Decision-Making | FDA Report on how to better communicate and expand the use of patient experience data in regulatory decision-making to the FDA. View Here
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…
How To Guide for Patient Engagement in the Early Discovery and Preclinical Phases How To Guide for Patient Engagement in the Early Discovery and Preclinical Phases | PFMD “PFMD: Guide for Industry, early discovery and pre-clinical scientists. This tool is primarily designed for and with all relevant stakeholders in mind: Read more…
National Hemophilia Foundation History Presentation NHF History Presentation | NBDF (formerly NHF) NBDF: A video that introduces the NBDF mission to an Industry partner, serving as an example of how a patient advocacy group may onboard an Industry partner. Watch Video
Bridge: Patient to Investigator Training Bridge: Patient to Investigator Training | COPD Foundation Training module preparing COPD patients and caregivers to work with researchers and become a part of study teams. Learn More Here
Mapping the Patient Journey Mapping the Patient Journey | DTRA DTRA: Downloadable journey maps, including Oncology Journey Map, the Rare Disease Journey Map, and the RSV Vaccine Journey Map, that PAGs can use to show patients visual path for clinical trial participation. Learn More Here
European Patients’ Academy on Therapeutic Innovation (EUPATI) Open Classroom European Patients’ Academy on Therapeutic Innovation (EUPATI) Open Classroom | EUPATI “EUPATI: Course for patient education in research and development. Free courses, personalized learning pathway, flexible e-learning, certificate course for a fee. “”EUPATI Open Classroom” by EUPATI (https://eupati.eu/) is licensed under Read more…
RareLaunch – Research Ready RareLaunch – Research Ready | NORD Course for PAGs to prepare for participation in research, especially in rare diseases: understand the basics of natural history studies, learn about the Institutional Review Board (IRB) Process, collaborate with researchers and industry, and leverage social media to recruit participants. Read more…
Phases of Clinical Trials Phases of Clinical Trials | CSL A one page sheet tailored for patients, their caregivers, and trusted healthcare providers, outlining the phases of clinical trials and methods for identifying relevant trial participation opportunities. View & Download Here
The 5 Steps in Drug Development The 5 Steps in Drug Development | NORD NORD: PDF handout from the RDCA and Critical Path Institute to help PAG Research staff understand the drug development process View & Download Here
Impact of Research When Your Organization Drives It Impact of Research When Your Organization Drives It | NORD NORD: Powerpoint presentation on the value of PAG involvement in research. View & Download Here
How to Connect with Scientists and Industry Stakeholders How to Connect with Scientists and Industry Stakeholders | NORD NORD: Enroll in the course to access a Power point presentation to help PAGs to inform how to engage with medical and scientific community on how to form a Medical/scientific advisory board Read more…
Getting Ready for Research as a Rare Disease Patient Advocate Getting Ready for Research as a Rare Disease Patient Advocate | NCAT NCATS: Powerpoint presentation from the NORD RareLaunch Research Ready Workshop that introduces Rare Disease Patient Advocates to resources for involvement in research. View & Download Here