Audience: Industry
I Am Included | Tigerlily
I Am Included I Am Included | Tigerlily Recommendations for Diverse Clinical Trial Site Leaders: An actionable framework for inclusive clinical trials. View Here
I Am Included I Am Included | Tigerlily Recommendations for Diverse Clinical Trial Site Leaders: An actionable framework for inclusive clinical trials. 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…
Building Clinical Trial and Health Research Access for People of Color via Community Health Centers (CHCs) Toolkit Building Clinical Trial and Health Research Access for People of Color via Community Health Centers (CHCs) Toolkit | Neighborhood Health Care and Altura This toolkit is a supplement to the white paper examining Read more…
Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials Patients Drive Authentic Trusted Solutions for Inclusive Clinical Trials | Article “A recently launched peer reviewed publication in Current Breast Cancer Reports which highlights Tigerlily’s Clinical Trial capabilities. Tigerlily believe that it is critical to engage all parts of the community Read more…
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
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…
HealthMatch Report: Quantifying Diversity, Equity and Inclusion in Clinical Trials HealthMatch Report: Quantifying Diversity, Equity and Inclusion in Clinical Trials A report with findings from a large clinical trial patient engagement survey. Users on the HealthMatch platform and received 7,903 responses among patients. Questions explored interactions with the health system, 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…
Achieving Diversity, Inclusion and Equity in Clinical Research Achieving Diversity, Inclusion and Equity in Clinical Research | MRCT Center of Brigham and Women’s Hospital and Harvard This Guidance Document aims to clarify the importance of, advance the goals of, and provide practical and actionable ways to improve diverse representation of Read more…
MS Minority Research Engagement Toolkit MS Minority Research Engagement Toolkit – Researchers | MS Minority Research Engagement Partnership Network (MS MREPN) Tools and discussion guides, evidence-based research on patient perceptions, resources for identifying community leaders and reaching out to different groups, and educational materials. These tools are intended to help Read more…
NIH All of Us Research Program All of Us Research Program | NIH The NIH All of Us Research Program provides an opportunity for everyone who wants to participate to provide health data to help build one of the most diverse health databases in history to help researchers learn how 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…
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