Presentation
Presented on: January 24, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: CBI conference on Clinical Data Disclosure, Transparency and Plain Language Summaries
Focus Area: Clinical Trials & Research
Diversity, Inclusion, and Equity in Clinical Research
Project-Specific Website
Released on: 2020
Improve Diversity in Clinical Research
Over the last 3+ years, the MRCT Center has focused on innovative and practical measures to increase diverse and inclusive representation in the clinical research enterprise.
Focused effort and dedicated action are needed to create an equitable clinical research environment. We hope this work inspires innovation and forward momentum to achieve diversity, inclusion, and equity in clinical research. We invite you to engage with us to enhance the document, resources, tools, and case studies.
Clinical Research Glossary website
Project-Specific Website
In 2020, the MRCT Center launched a pilot project to develop a plain language clinical research glossary with an amazing workgroup of patient advocates and other representatives from across the clinical research industry.
The team worked together to create clinical research definitions and explanations that are:
- plain language
- understandable to a wide audience
- in line with industry and regulatory standards
For more information, please visit the MRCT Center Clinical Research Glossary website.
Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Publication
Presented on: December 19, 2019
Published in: Duke Margolis Center for Health Policy
Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Publication
Published on: November 2019
Published in: Duke Margolis Center for Health Policy
Efficiencies in Clinical Research: A USA perspective
Presentation
Presented on: October 8, 2019
Presented at: Translational Research Institute (TRI) Australia
A USA perspective on diversity and inclusion
Presentation
Presented on: October 3, 2019
Presented at: ACTA Australia
Health Literacy Best Practices: Plain Language
Toolkit
Developed on: October 2019
Developed by: MRCT Center Health Literacy Workgroup
Related Resources
See related Resources, maintained on our project specific Health Literacy website:
Determining Real-World Data’s Fitness for Use and The Role of Reliability
Publication
Published on: September 26, 2019
Published in: Determining Real-World Data’s Fitness for Use and The Role of Reliability
Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research
Publication
Published on: July 12, 2019
Published in: JAMA
The current opioid epidemic has particular importance for pregnant women with opioid use disorder (OUD). Heroin addiction, use and misuse of prescription opioids for treatment of pain, and medication-assisted treatment are all increasing.1 Between 1999 and 2014, the number of pregnant women using opioids in the United States increased significantly from 1.5 to 6.5 per 1000 deliveries.2 In utero opioid exposure can cause neonatal abstinence syndrome (NAS), a disorder characterized by central nervous system and autonomic nervous system dysfunction. Despite the increasing frequency of NAS, key knowledge gaps exist including uncertainty about whether, when, and how to treat these neonates, how to wean medications, and the optimal agent(s) to use.1 The short- and long-term efficacy and safety of various maternal and neonatal treatments are unknown, and additional research is needed.
