Principles for Compensating Patients for Patient Engagement Activities Principles for Compensating Patients for Patient Engagement Activities | The National Health Council A set of best practices from the National Health Council on providing compensation to patients. View Here
Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap | Stegemann et al Read more…
Patient Experience: Gratitude Toolkit Patient Experience: Gratitude Toolkit | TransCelerate TransCelerate, in partnership with patients/care partners, sites, and industry sponsors, developed the Gratitude Toolkit (GRAT), a set of deliverables that sponsors, with their site partners, can leverage to acknowledge and show appreciation to clinical trial participants. The GRAT streamlines options Read more…
Solution Implementation Experiences Solution Implementation Experiences | TransCelerate TransCelerate has received 100+ experiences reported from organizations that have implemented and benefited from TransCelerate solutions. Anyone can submit an experience or search the library to see how the solutions can benefit their organizations and help accelerate answers for patients. View Here
Study Participant Feedback Questionnaire Toolkit Study Participant Feedback Questionnaire Toolkit | TransCelerate The Study Participant Feedback Questionnaire (SPFQ) is a survey provided to study participants at the beginning, middle and end of a clinical study. View Here
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…
IRB and HRPP Toolkit IRB and HRPP Toolkit | MRCT Center of Brigham and Women’s Hospital and Harvard Resources for IRBs/HRPPs to provide to Investigators/Research Teams. Includes resources on participant costs, payments to research participants, including the community voice in clinical research, incorporating DEI into Clinical Research Protocol Templates, incorporating Read more…
Equity by Design in Clinical Research: The EbD Metrics Framework Equity by Design in Clinical Research: The EbD Metrics Framework | MRCT Center of Brigham and Women’s Hospital and Harvard Designed to provide a straightforward and engaging overview of DEI in clinical research, to prompt reflection for harmonized organizational DEI Read more…
Inclusion by Design: Building Equity in Clinical Trials Through the Lens of Metastatic Breast Cancer Inclusion by design: building equity in clinical trials through the lens of metastatic breast cancer | The Health Policy Partnership Wilcox H, Wheeler E, Wait S. 2023. Inclusion by design: building equity in clinical trials 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…
Sponsorship Agreement Template Sponsorship Agreement Template | Template Shared by PALADIN Member Sample Sponsorship Agreement Template. 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…
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…
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…