Informed Consent for Clinical Trials Informed Consent for Clinical Trials | FDA Informational page on the FDA website covering the requirements for informed consent in clinical trials. The page includes an explanation of informed consent, what information is required to be collected from participants, participant rights, and language suggestions. View Read more…
Institutional Review Board Written Procedures: Guidance for Institutions and IRBs Institutional Review Board Written Procedures: Guidance for Institutions and IRBs | OHRP A guidance from the Department of Health and Human Services (HHS’s) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) on procedures for IRB Read more…
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…
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…
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…
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…
ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development ICH Reflection Paper: Proposed ICH Guideline Work to Advance Patient Focused Drug Development | ICH Importance of bringing patient perspective in clinical research a series of drug development and regulatory decision-relevant questions that arise during the drug Read more…
Patient Engagement Patient Engagement | National Health Council Guidance for PAGs on fairly and adequately capturing patient voice in clinical research. Learn More Here