MRCT Resources MRCT Resources| MRCT Center of Brigham and Women’s Hospital and Harvard “MRCT Center resources include case studies, framework and guidance documents, meeting summaries and webinar recordings, presentations, publications, and more.Information on the MRCT (Multi-Regional Clinical Trials) Center at Brigham and Women’s Hospital with four primary areas of focus Read more…
Benchmarking Patient Recruitment and Retention Practices Benchmarking Patient Recruitment and Retention Practices | Article “Results from the 2020 study that benchmarks patient recruitment and retention practices across global clinical trials.Lamberti, M. J., Smith, Z., Henry, R., Howe, D., Goodwin, M., Williams, A., & Getz, K. (2021). Benchmarking Patient Recruitment and Read more…
Touch, the Black Breast Cancer Alliance Touch, the Black Breast Cancer Alliance Touch, The Black Breast Cancer Alliance drives the collaborative efforts of patients, survivors, advocates, advocacy organizations, health care professionals, researchers, and pharmaceutical companies to work collectively, with accountability, towards the common goal of eradicating Black Breast Cancer. Learn Read more…
DIA Patient Centricity Research Summary Results DIA Patient Centricity Research Summary Results | DIA Results from the 2016 study that benchmarks adoption and impact of patient-centric initiatives in drug development. This research aimed to measure the impact of patient engagement across research and development. This is the first-of-its-kind research to Read more…
American Kidney Fund YouTube playlist on Clinical Trials American Kidney Fund YouTube Playlist on Clinical Trials | AKF A variety of informational videos are available to educate patients about clinical trials. These videos cover crucial topics such as the significance of diversity, participation, and debunking common myths and facts associated Read more…
Kidney Health for All Kidney Health for All | AKF An example of comprehensive clinical trial information that encompasses the importance of representing all individuals and highlights the advantages of participating in clinical trials. Learn More Here
American Kidney Fund Clinical Trials Overview and Toolkit American Kidney Fund Clinical Trials Overview and Toolkit | AKF Clinical trials play a pivotal role in advancing the treatment of chronic kidney disease and other kidney ailments. Discover the inner workings of clinical trials and determine if you meet the criteria Read more…
Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation Plain Language Summaries (PLS) of Peer-Reviewed Publications and Conference Presentations: Practical ‘How-To’ Guide for Multi-Stakeholder Co-Creation | PFMD “A practical guide for collaborative development of plain language summaries (PLS) for peer-reviewed publications and conference Read more…
Working with Community Advisory Boards: Guidance and Tools for Patient Communities and Pharmaceutical Companies Working with Community Advisory Boards: Guidance and Tools for Patient Communities and Pharmaceutical Companies | IHI (formerly IMI) PARADIGM A toolkit encompassing guidance and resources related to community and patient advocacy in the healthcare industry. View 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…
Patient Engagement in Early Dialogues: Tools and Resources for HTA Bodies Patient Engagement in Early Dialogues: Tools and Resources for HTA bodies | IHI (formerly IMI) PARADIGM Downloadable toolkit for HTA bodies. This resource contains three main sections covering the rationale for engaging and involving patients in Early Dialogues, an Read more…
How To Guide for Patient Engagement in the Early Discovery and Preclinical Phases How To Guide for Patient Engagement in the Early Discovery and Preclinical Phases | PFMD “PFMD: Guide for Industry, early discovery and pre-clinical scientists. This tool is primarily designed for and with all relevant stakeholders in mind: Read more…
Patient Engagement in Medicines Development: Recommendations on How to Find the Right Match for the Right Patient Engagement Activity Patient Engagement in Medicines Development: Recommendations on how to find the right match for the right patient engagement activity | IHI (formerly IMI) PARADIGM PARADIGM: Guidance for Industry and PAGs providing 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…
Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials Public Workshop on Enhancing the Incorporation of Patient Perspectives in Clinical Trials | CTTI and FDA Workshop on ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, Read more…
National Hemophilia Foundation History Presentation NHF History Presentation | NBDF (formerly NHF) NBDF: A video that introduces the NBDF mission to an Industry partner, serving as an example of how a patient advocacy group may onboard an Industry partner. Watch Video
Patient Engagement Patient Engagement | National Health Council Guidance for PAGs on fairly and adequately capturing patient voice in clinical research. Learn More Here
Bridge: Patient to Investigator Training Bridge: Patient to Investigator Training | COPD Foundation Training module preparing COPD patients and caregivers to work with researchers and become a part of study teams. Learn More Here