The Keck School of Medicine of USC has a number of new initiatives that are creating a more streamlined and user-friendly environment to help faculty members succeed in managing their clinical research, often a time-consuming and complicated undertaking.
The USC Clinical Trials Office (CTO) handles administrative aspects of industry-funded clinical trials, including coverage analysis, contracting, budget development and post-award financial management. The CTO also conducts coverage analysis and provides assistance with budget development for federally funded clinical trials.
The Keck School has operated the CTO for schools on the Health Sciences Campus since January 2016, administrators said. During that time, the CTO staff has doubled in number, enhancing available services. A backlog of 246 studies pending activation has been cleared and the rate of activation has increased from an average of 8 to 15 studies per month. The rate of submissions has increased from an average of 11 to 24 per month, reflecting a rapid expansion of the Keck School’s clinical trial portfolio.
The CTO now has a goal of activating all trials within 90 days of their submission.
“With increasing competition in site selection by industry sponsors and aggressive enrollment deadlines, it is now more important than ever to be efficient and conscientious as a site in quickly getting a study open to enrollment,” said Melissa Archer, JD, CTO director.
The Southern California Clinical and Translational Science Institute (SC CTSI), funded by the National Institutes of Health, provides services and resources to researchers at USC and Children’s Hospital Los Angeles (CHLA). The Clinical Research Support group of the SC CTSI provides a wide variety of resources to support clinical research. Researchers can access biostatistical support, regulatory advice, a pool of study coordinators, recruitment services, and an outpatient Clinical Trials Unit. They can also access pilot funding, research vouchers, and team building expertise. Finally, SC CTSI provides multiple funding mechanisms for fostering innovative, multidisciplinary, and pilot projects.
“We also have a mechanism in place to provide free consulting hours for research teams to strategize recruitment,” said April Armstrong, MD, MPH, associate dean for clinical research and associate professor of clinical dermatology. “This includes both traditional recruitment venues as well as social media platform strategies.”
Armstrong also outlined how the online Keck Medicine Clinical Studies Directory is being updated to feature more patient-friendly listings of trials that are actively recruiting.
The SC CTSI, CTO and other support teams have launched the Clinical Research Harmonization Initiative with the goal of developing a more streamlined process for submission and activation of clinical trials. The Initiative has already eliminated many unnecessary processes involved in trial activation. Creation of a single portal for trial submission is the next goal.
“The Keck School and the dean consider clinical research to be a high priority,” said Thomas A. Buchanan, MD, vice dean for research and the director of the SC CTSI. “We’ve made major investments in the infrastructure, and because of our expanded resources, submissions are up and they are getting processed much more quickly.”
Other major initiatives underway at the Keck School are a research data warehouse that contains clinical data from the Keck School, CHLA and Los Angeles County Department of Health Services, and an electronic clinical trials management system for activation and conduct of clinical trials.
“It is a new era for clinical research at the Keck School,” Buchanan said. “We look forward to growing our clinical research enterprise substantially as we make the whole process easier for our research community.”
Interested faculty can learn more about the resources available for clinical trials at a town hall Monday, Oct. 23 from 4-5:30 p.m. in Mayer Auditorium. For more information, contact Julie Carl at email@example.com.
— Amanda Busick