Audience: Industry
I Am Included | Tigerlily
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Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap
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Audience: Industry & PAG
Building Clinical Trial and Health Research Access for People of Color via Community Health Centers (CHCs) Toolkit
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Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials
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Audience: PAG
Caregiver Recommendations for Enhancing Clinical Trial Participation Diversity
Caregiver Recommendations for Enhancing Clinical Trial Participation Diversity Caregiver Recommendations for Enhancing Clinical Trial Participation Diversity | NAC Recommendations from caregivers to enhance clinical research participation View Here
Audience: Industry
IRB and HRPP Toolkit
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Audience: Industry
Equity by Design in Clinical Research: The EbD Metrics Framework
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Audience: PAG
HealthMatch Report- Quantifying Diversity, Equity and Inclusion in Clinical Trials
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Audience: Industry
Inclusion by Design: Building Equity in Clinical Trials Through the Lens of Metastatic Breast Cancer
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Audience: Industry
FDA Guidance on Engaging Community and Advocates in Diversity
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Audience: Industry & PAG
Achieving Diversity, Inclusion and Equity in Clinical Research
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Audience: PAG
MS Minority Research Engagement Toolkit
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Audience: PAG
NIH All of Us Research Program
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Audience: Industry
Assessment of the Use of Patient Experience Data in Regulatory Decision-Making
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
Audience: Industry
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
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Audience: Industry
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
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Audience: Industry
FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making
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Audience: Industry & PAG
CDER Patient-Focused Drug Development
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Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity
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Audience: PAG
MS Minority Research Engagement Toolkit – Clinicians
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