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.
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. A limited number of surveillance systems have utilized innovative analytical and statistical techniques, including data mining, machine learning, and artificial intelligence, to interrogate real-world data. While these approaches are important and complementary, they fail to harness the full power of cooperation across stakeholders and of global inclusivity. In collaboration with others, the MRCT Center is launching the Proactive Safety Surveillance initiative which aims to improve upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s).
As the official launch to the project, on May 3, 2019, MRCT Center will invite stakeholders from industry, government and academia to participate in an invitation-only small meeting or Visioning Session in order to identify the salient issues, the challenges, the opportunities and to further explore the need for and characteristics of such an approach. The session will be a partnership of best minds with diverse perspectives to enable the evaluation and adaptation of new technologies, methodologies, and insights to better support the determination of the medical importance and validity of safety signals for the global community. While inevitably challenging, we believe exploration of such questions holds the promise of increasing the timely detection, validation, and communication of important safety information.
