Introducing a new method for tracking and monitoring NIA’s clinical studies
As part of our mission, NIA conducts and supports many longitudinal and clinical studies on aging that generate a vast collection of unique data. In 2011, the National Alzheimer’s Project Act was signed into law, followed by subsequent appropriations for a significant increase in funding for Alzheimer’s disease (AD) and AD-related dementias (ADRD) research.
Since then, NIA extramural staff have been working hard to better manage and coordinate an unprecedented corresponding increase in the amount of AD/ADRD-focused clinical research, related documents, and data. To provide a more efficient and seamless research experience for both our program staff and NIA awardees, NIA recently began developing our new Clinical Research Operations and Management System (CROMS). CROMS will provide NIA-wide capability to track, report, and manage our extramural clinical research data, activities, and portfolio in real time.
What CROMS means for NIA’s extramural research community
One of the biggest hurdles in advancing AD/ADRD research is recruitment and retention of participants in clinical studies, particularly among underrepresented populations. Although CROMS alone will not directly solve this critical issue, it is our hope that its ability to track participant enrollment in NIA-funded studies in real time will enable us to intervene early to assist grantees with enrollment challenges.
Although CROMS will eventually be used by all program staff and any investigators with NIA grants supporting human subjects research, our initial focus, in fiscal year 2021, will be for those grants supporting AD/ADRD clinical trials. If you are an NIA grantee enrolling participants in clinical studies, we will provide training and support moving forward to help you get the most out of CROMS. In the meantime, you can look forward to the following exciting CROMS benefits that will enable users to:
- Generate reports and inclusion enrollment tables formatted to meet requirements for annual NIH/NIA reporting (and save you from having to enter data twice!)
- Set up and receive automatic reminders related to NIA grant activities (e.g., approaching deadlines, study milestones, and enrollment milestones) to automatically track progress in one system, while reducing reliance on email threads
- Access tools/visualizations to monitor actual participant enrollment against planned enrollment for each study
- View the study-specific data and documents you share with NIA in one central system (e.g., participant enrollment data, investigator information, site information, and final study documents)
- Receive information on best practices around enrollment and retention that have been identified and summarized through CROMS
Stay Tuned for Future Updates on CROMS
While we are currently in the early stages of developing CROMS, we will reach out directly to many of our grantees — especially those with grants funding AD/ADRD clinical trials — in the near future with more information. If you have any questions or comments on how CROMS can help you and your research team, please comment below or email me for more details.