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Research Team Turns to Library to Help with Quick FDA Submission Deadline

Dr. Farhan Siddiq, MD, a neurosurgeon with MU Health Care, recently embarked on a Food and Drug Administration submission project for a National Institutes of Health funded multi-site medical device clinical trial. The trial is looking at a device to be used on patients with chronic subdural hematoma, which is a bruise under the skull that can compress the brain. While the clinical trial includes both researchers at Harvard and University of Texas, it was Dr. Siddiq’s team at MU that was tasked with completing the FDA submission. The submission required a thorough review and summary of information in the literature regarding all uses of the medical device. The team needed to get their hands on and review hundreds of papers quickly to write the summaries and develop the bibliography. With this huge project on the horizon, the research team looked to the Health Sciences Library for assistance.

Suzan Moser, the director of regulatory affairs at the MU Institute for Clinical and Translational Science and a member of the research team for the project, says that contacting the library was natural “From past FDA submissions, I know the benefits of a good medical library and librarian. I asked the Dean of Research’s office in the School of Medicine to recommend someone. She suggested Rachel Alexander, and we are forever grateful,” says Suzan.

Rachel Alexander
Research Support Librarian

With Rachel Alexander, the research support librarian at the Health Sciences Library, on board, the team quickly fulfilled the FDA submission requirements. Rachel ran several searches and worked with Dr. Siddiq to pull relevant manuscripts, eventually working with Katy Emerson in the library’s Interlibrary Loan department to get copies of all 250 articles to be reviewed, with the library having access to most of the articles and only borrowing 19 from other libraries. Dr. Siddiq and Rachel further boiled down the list of articles to 158 that they would submit to the FDA. With the final 158 articles, Rachel created bibliographies for the protocol, proposal and literature summary.

In all, searching the literature, pulling the articles, and choosing the articles took about 85 hours and Rachel was there every step of the way. According to Suzan, Rachel spoiled the research team with all of her assistance.

“Rachel’s knowledge about how to find, access, organize and file the publications so all team members could easily use them was most valuable. Her extreme reliability, flexibility and excellent communication skills are most noteworthy,” says Suzan.

If you are embarking on a literature review for a project, whether big (like an FDA submission) or small, consider contacting the Health Sciences Library for a consultation.

Cycle of Success is the idea that libraries, faculty, and students are linked; for one to truly succeed, we must all succeed. The path to success is formed by the connections between University of Missouri Libraries and faculty members, between faculty members and students, and between students and the libraries that serve them. More than just success, this is also a connection of mutual respect, support, and commitment to forward-thinking research.

If you would like to submit your own success story about how the libraries have helped your research and/or work, please use the Cycle of Success form.

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Taira Meadowcroft

Taira Meadowcroft is a Health Sciences Librarian at the University of Missouri. She focuses on quality improvement, reference, and marketing for the University of Missouri Libraries.