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…
CIOMS Working Group XI – Patient Involvement CIOMS Working Group XI – Patient Involvement | CIOMS Published in 2022, this report underscores the essential role of patient involvement throughout the entire lifecycle of medicine, from early development to regulatory processes and ongoing healthcare usage. It offers a comprehensive overview of Read more…
Patient Focused Medicines Development (PFMD) Patient Focused Medicines Development (PFMD) “Information on PFMD, A global collaborative and non-competitive coalition to Improve global health byco-designing the future of healthcare for patients with patients.The PFMD network is making sure to aggregate existing knowledge and tools, identifying good practices and coherently combining them 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
Clinical Trials Transformation Initiative Clinical Trials Transformation Initiative | CTTI Information on CTTI (Clinical Trials Transformation Initiative). View Here
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
CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials | FDA An overview of a March 2019 CTTI and FDA Public Workshop on Enhancing the Incorporation of Patient Perspectives Read more…
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
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry | FDA Guidance for sponsors intended to support a new drug application or a Read more…
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…
CDER Patient-Focused Drug Development CDER Patient-Focused Drug Development Overview of PFDD (Patient-Focused Drug Development). View Here
Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity | Therapeutic Innovation & Regulatory Science Scant empirical data exists regarding the racial and ethnic demographics of professionals overseeing pharmaceutical and biotech-funded clinical trials and their Read more…
Clinical Trials Recruitment Planning: A Proposed Framework from CTTI Clinical Trials Recruitment Planning: A Proposed Framework from CTTI | Contemporary Clinical Trials Journal “Article that examines the challenges and issues actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. Articledescribes a framework that delineates three areas Read more…
MS Minority Research Engagement Toolkit – Clinicians MS Minority Research Engagement Toolkit – Clinicians | PCORI Tools and discussion guides, evidence-based research on patient perceptions, resources for identifying current opportunities, and educational materials to download for your patients. View & Download Here
A Secondary Qualitative Analysis of Stakeholder Views About Participant Recruitment, Retention and Adherence in Decentralised Clinical Trials (DCTs) A Secondary Qualitative Analysis of Stakeholder Views About Participant Recruitment, Retention and Adherence in Decentralised Clinical Trials (DCTs) | Article “An overview of recruitment, retention, and adherence in DCTs.Coyle J, Rogers A, Read more…