Aug. 13, 2014 - Staff from the Duke Office of Clinical Research can provide ‘just-in-time’ help for recruitment, data management and other research needs
Duke Office of Clinical Research's Sarah Timberlake (at whiteboard) guides a research management team meeting with investigator Chip Bailey (second from left). Photo by Duke University Photography.
Last January, Donald (Chip) E. Bailey Jr., was running out of time.
Bailey, an associate professor in Duke’s School of Nursing, was struggling to recruit providers and patients for his study about therapies and management of chronic hepatitis C. Each week he would try to manage recruitment both at Duke and at a small clinic in eastern North Carolina, encouraging his already busy staff to keep track of and follow-up with participants. He needed 18 patients, plus several providers and it simply wasn’t happening. “It was a critical time,” he said.
To help push through this barrier, Bailey brought in additional resources from a Research Management Team organized by the Duke Office of Clinical Research (DOCR).
The RMT at DOCR provides services such as database development, protocol review and consultation, subject recruitment and follow-up, data transcription, and study closeout procedures. These services are available to researchers precisely when they are needed, with very little lead-time or training required to get staff up to speed. This quick response saves investigator’s money, ensures studies are up and running quickly and efficiently, and allows investigators to focus on the science rather than the administrative details.
With eight data management staff and 11 research coordinators available, the DOCR Research Management Team stands ready to help a large number of investigators. While many services are fee-based, Duke’s Clinical and Translational Science Award (CTSA) funding from NIH offsets DOCR overhead, allowing DOCR to provide free consultations and educational services. Leveraging these resources can help researchers get studies off on the right foot.
Phyllis Kennel, director of Research Support and research practice manager of the School of Nursing’s Clinical Research Unit, has been leaning on RMT services for several years. The unit’s studies are usually small, often requiring 20 percent or less of a research coordinator’s time. Kennel said claiming RMT staff time is much more efficient than trying to hire new staff when funding is obtained. “They are seasoned, trained and ready to go,” she said. “The learning curve is small, allowing them to jump in quickly. Administratively, it is a huge non-headache experience!”
RMT also offers data management service. Emmanuel (Chip) Walter, a Duke pediatrician, calls upon RMT when he needs databases developed quickly. Over the last 12 months, he has used RMT staff to create two databases for his studies on responses to pediatric vaccines. “We’ve thrown two pretty different studies at DOCR,” he said. “They adapted to the challenge.” Walter has two more databases in the works and plans to continue to use DOCR’s services.
Even individuals still learning about research can benefit from RMT services. Advanced practice nurse participants in the Duke-Johnson & Johnson Nurse Leadership Program often include in their coursework proposed projects that require IRB approval. Many have not had prior experience with an IRB or with designing and implementing a research project. Claudia Graham, coordinator for the leadership program, brings in RMT consultants to help nurses navigate this new world. The consultants review IRB protocols prior to submission and guide participants through the IRB submission process. Graham says the consulting resource has been very helpful and would “absolutely recommend these services to other programs that don’t have the staff with the amount of expertise found in the Duke Office of Clinical Research.”
Back in January, Bailey’s call to the RMT saved the day for his study. With the help of a project manager and one additional staff member from the RMT, his clinical trial recruited enough subjects to close enrollment, and then surpassed his goal by recruiting two additional participants.
“The RMT staff turned the ship around and enhanced our relationship with providers and clinics,” he said.
article written by Sheila M. Ray
originally posted at https://www.dtmi.duke.edu/news-publications/research-management-teams-to...