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.
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:
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.
As the launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.
Dr. Robert Califf, former Commissioner of FDA, delivered the opening keynote entitled, ‘New Possibilities for Medical Product Safety in the Digital Revolution.’ The conversation that followed was expansive, thought-provoking, and dynamic. Diverse perspectives on many topics were considered, including the sources, curation, and use of data; the importance of understanding the benefit to risk and not simply a safety risk; communication of the balance of benefit and risk to patients; and communication between stakeholders, regulators, and the global population. The MRCT Center will continue to explore the themes identified during the meeting to develop a concrete plan for the future.
