New Home for the USC Clinical Trials Office

On January 1, 2016, the USC Clinical Trials Office (CTO) moved into the Keck School of Medicine. The School is committed to providing efficient, transparent and user-friendly service to investigators and research teams conducting clinical trials and other studies that require health system resources at USC. To achieve these goals, the Keck School has combined the formerly separate pre-award (contract budgeting and negotiation) and post-award (accounts payable and accounts receivable) functions into a single unit that will provide all of these functions for industry-sponsored clinical trials, and coverage analysis as part of the budgeting process for all clinical trials, regardless of sponsor. We conducted a national search that led to hiring of Melissa Archer as the new director of the CTO. Melissa has strong experience in leadership and in clinical trials operations. She will work closely with me and with Ted Budge from the Dean’s Office to ensure that the staffing and operations of the CTO meet the needs of our clinical research community and the patients they work with.

Going Live with Our Clinical Trials Management System, OnCore

One of the major advances that will help streamline our clinical research operations is the implementation of our new clinical trials management system, OnCore. OnCore is designed to support the initiation, manage¬ment, and financial accounting of clinical research studies. The OnCore team has been pilot testing the system with different types of studies. It will go live for all new clinical trials on April 1, 2016. A series of training sessions is being offered in March to be sure that staff members are ready to use OnCore when it goes live on April 1. For information about training in OnCore, contact Amanda Schmitz at Amanda.Schmitz@med.usc.edu.

i2b2 – A New Tool for Planning and Recruiting for Clinical Studies

An early challenge in designing clinical studies is estimating your sample size. Statistical approaches help you estimate the power of various sample sizes, but you also need to know the feasibility of recruiting a cohort that will provide solid statistical power. I am delighted to introduce to you a new online tool that can help. It is called Informatics Integrating Biology & the Bedside (i2b2 for short). I2b2 was developed by members of the national Clinical and Translational Science Award (CTSA) consortium to get “counts” of potential study participants who meet specific inclusion and exclusion criteria. I2b2 is now live at USC and CHLA, where you can use it to help refine your target study cohort. Using a self-service interface, researchers can drag-and-drop various study entry criteria (e.g., age, diagnosis, medications, recent lab results) and – through the magic of informatics – find out how many patients in the Keck Medicine and/or CHLA electronic health record(s) meet the criteria. Change the entry criteria and see how a slightly different study design will affect the pool of potential participants. No protected health information is provided by i2b2, so there is no risk to patient privacy. All you get is counts. But fear not – that is not where this resources stops. Once you finalize your study design and get IRB approval to open enrollment, you can submit the results of your i2b2 query to request contact information for the potential participants. In my mind, this is a major advance in our ability to support study design and recruitment at USC and CHLA. Thanks to the Health Information Technology teams at CHLA and Keck and the SC CTSI Clinical Research Informatics team for implementing i2b2 here at USC and CHLA!

You can use i2b2 if you are an investigator or research team member at USC or CHLA. All you need is an i2b2 account, which you can request by emailing the i2b2 support team i2b2@usc.edu, or by calling the SC CTSI Clinical Research Informatics Program (323) 442-0217 and asking for i2b2 support (9-5pm Monday-Friday).

More information about i2b2 at USC and CHLA, including upcoming training events for using i2b2, is available on the SC CTSI website.

Give it a try!

New Program to Expand Research Career Development at the Keck School

Part of expanding our research programs is developing a pipeline of young talent who are serious about pursuing careers in biomedical research. The National Institutes of Health offers a variety of Career Development (K) Awards that support mentor-guided research career development for our next generation of researchers. A description of the types of K awards can be viewed at https://www.nichd.nih.gov/training/extramural/Pages/career.aspx. Dean Puliafito has provided resources to establish a new Research Career Development Program with the Keck School. Cecilia Patino-Sutton, MD PhD, who has contributed greatly to the success of the KL2 program of the Southern California Clinical and Translational Science Institute, has agreed to lead this new program. Cecilia has already started meetings with departments at the Keck School to identify junior faculty members or senior post-doctoral fellows who are strong candidates for K-awards. She will provide a variety of resources and advice to help them develop successful applications and turn them into long-term independent funding. If you have questions or want to arrange a presentation for your department, contact the program director, Cecilia Patino-Sutton, at patinosu@med.usc.edu or the program manager, Jeanne Dzekov McKean, at dzekov@usc.edu.