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Introducing a new method for tracking and monitoring NIA’s clinical studies

Holly Massett
Holly MASSETT,
Division of Extramural Activities (DEA).

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.

Comments

Submitted by Robin Kruse on September 28, 2020

At the moment, this sounds like an unfunded mandate. We have already developed a data collection and monitoring system that works very well for us. Adding data to CROMS simply means double-entering, an unnecessary task that NIA says they wish to avoid. Further, what guarantee do we have that our data are secure and that no one else will publish our findings before we do? We could easily add enrollment data into a database at the time of annual reporting instead of weekly entry in CROMS.

Submitted by Holly Massett on September 29, 2020

In reply to by Robin Kruse

To clarify, CROMS will only collect study enrollment data – no clinical data will be ever requested or entered into CROMS; therefore, study results or endpoints cannot be revealed in any capacity by the new system.  The collection of enrollment data into CROMS is to ensure that federally-funded NIA clinical studies enroll participants within the specified parameters of the grant and timeline; and to provide NIA leadership the ability to respond quickly and accurately to inquiries from other oversight bodies (e.g., Congress).  CROMS will be a secure, password protected site and only NIA-authorized users will be able to access its data.

In planning for CROMS, NIA conducted outreach with our grantees in Fall 2019 to identify potential impacts that could be addressed in the design and development of the system. We learned that the majority of grantees were already collecting enrollment data on a daily or weekly basis (e.g., Redcap, data coordinating centers, Excel spreadsheets); CROMS will seek to receive enrollment data monthly from grantees.  NIA does not intend to have its grantees perform double data entry; as such, CROMS will support multiple mechanisms for grantees to securely submit data, including: 1) a one-time setup of automated exchange to push data into CROMS on a monthly basis; 2) uploading a spreadsheet (e.g., Excel) into CROMS based on a data pull from your own system; or, 3) direct entry into CROMS via a secured web portal.  Such methods have been in use via similar systems at other NIH institutes (e.g., NIAID) and have been shown to be low burden and easy to perform by grantees with minimal impact on workload.

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