OB/GYN embraces new ways to streamline research
Anna Girsen, MD, PhD, came to Stanford from Oulu, a city in northern Finland known for colorful northern lights, an international air guitar competition, and a citizenry that loves to try out new technologies. As one of Europe’s “living labs,” this community earns its keep by debugging all sorts of futuristic innovations — from artificial intelligence to super-fast 6G wireless networking.
When Girsen became the Clinical Research Operations Manager in the Department of Obstetrics and Gynecology, she brought Oulu’s “living labs” heritage with her. In this role, she’s piloting better ways to manage research studies, with the goal of increasing the throughput, quality, and impact of research conducted in her department.
New tools and processes
In the last year, Girsen has led the charge to upload OB/GYN’s 40 or so non-cancer clinical studies onto OnCore, Stanford’s institution-wide clinical research management system. This software system serves as a centralized resource for study management and research participant tracking. It features easily accessible reports, dashboards, and metrics that enable leaders to quickly check the status of the studies within an organization, to identify those that may need more staffing or recruitment support. The OnCore support team, led by manager Yona Shulaker, is currently piloting new OnCore functionality with OB/GYN, with an eye towards sharing these with other groups. These reports and visualizations make it easier for groups to continually assess and improve processes.
Girsen’s department is also an early adopter of the new Clinical Research Unit (CRU) program, recently launched by the School of Medicine’s Research Office. This program establishes standing committees within a department or division to provide scientific reviews and feasibility assessments for new studies, as well as oversight for ongoing research activities. These expert reviews, which happen before the Institution Review Board (IRB) reviews a study, aim to improve the quality of study protocols, identify potential collaborators, and optimize staff resources.
Next steps for OB/GYN’s CRU
Using the scientific rigor she learned as a fetal-maternal health researcher in Finland, Girsen will evaluate the program once the first two studies have run the gamut of the CRU process. Then she’ll get feedback from the teams to improve it. She emphasizes that there will be rewards for the research teams that participate.
“We’re asking the teams to do something extra, and in exchange, we’ll provide them with shared resources and expert feedback that will improve their studies,” Girsen said. For example, she’s organizing a shared library of grant proposals, standard operation procedures, and training log templates.
Of course, none of this would be possible without the support of group leaders such as OB/GYN’s Leslee Subak, MD, who became the department chair in 2017.
“I am absolutely tickled by the opportunity to streamline women’s health research through OB/GYN CRU and these new tools,” said Subak. “I look forward to the improved processes and enhanced research collaboration within our Department and across the University.”
Though there will be some birthing pains in the beginning, Girsen is confident that adopting the “living lab” way of doing things will help establish Stanford’s OB/GYN department as a leader in academic research.
“Yrittänyttä ei laiteta,” Girsen said, which, roughly translated from Finnish means, “Nothing ventured, nothing gained.”
For more information on establishing a Clinical Research Unit (CRU) program in your division or department, contact Peg Tsao at email@example.com. In addition, Kenneth Mahaffey, MD, will field questions on the CRU program during the School of Medicine’s Council of Clinical Chairs meeting on October 25.