January = OnCore Rollout

In an era that has seen the link between the bench and the bedside come fully into focus, the role of clinical research in that space has become better understood. This puts clinical researchers in the spotlight as it were, with the public pushing ever harder for breakthroughs to understand disease processes and prevention strategies, and to improve health and quality of life.

But clinical research has never been quick, often requiring many research participants to be followed for a fairly long time to prove the safety and effectiveness of a potential new drug, device, or treatment. Quality, compliance, and data integrity can require many complex steps and a large team.  Thus any system that helps provide a better infrastructure for conducting and managing clinical research is welcomed by researchers.

Enter OnCore®, a clinical trials management system (CTMS), which Kenneth Mahaffey, MD (professor, Cardiovascular Medicine and vice chair of clinical research), describes as software that “will provide incredible advantage to clinical investigators and leadership to manage our growing clinical research portfolio.” OnCore is entering pilot studies in several divisions in the Department of Medicine in January. It has already been in use successfully at Stanford’s Cancer Institute for over 10 years.

Lisa Jackson, Executive Director of Stanford’s Center for Clinical & Translational Research & Education (Spectrum) explains that the early adoption of CTMS by cancer institutes, including the Stanford Cancer Institute, as directed by the National Cancer Institute, has led to an exponential growth in the use of these platforms. OnCore® will enable improved tracking and management of clinical research at the institutional level with the goal of reducing administrative burdens and increasing the pace and volume of research, while protecting the safety of research participants.

According to Yona Shulaker, process improvement manager for Spectrum, this initiative extends the use of OnCore as OnCoreEnterprise, allowing its use for non-cancer clinical research at Stanford. “Similar functionality to that used for Cancer Institute studies will first be available for pilot users in the Department of Medicine,” she says, “and then rolled out in stages to more School of Medicine departments.”

That functionality means that within the Department of Medicine, OnCore will “help investigators be more efficient in their work in tracking protocols and patients,” says Rebecca McCue, associate director for site-based research at the Stanford Center for Clinical Research (SCCR). “The long-term vision is for OnCore to become an integrated portal to billing, participant reimbursement, IRB, and Grants and Contracts.” Right now, however, SCCR is focusing on introducing OnCore in just three groups: the Divisions of Gastroenterology & Hepatology and of Cardiovascular Medicine, and the Cardiovascular Institute.

Progress to this point has been measured but rapid. Since the contract for OnCore was signed in June 2015, pilot users were identified; focus groups met; workflows, manuals, and a website have been developed; and training began. Study coordinators have been center stage since they will have their hands on the software as they perform their usual duties, and faculty have been engaged as the principal investigators of the research.

What will OnCore mean to the Department of Medicine? First, comprehensive centralized data on all clinical research; second, streamlined reporting and timely metrics; third, standard and readily available tools for coordinators to manage participants and protocols. This data will enable researchers and leadership to make strategic decisions, increase efficiency, and identify areas to reduce start-up timelines.  Eventually, other modules will be employed and budgeting, billing, and effort tracking, among other processes, will be streamlined and improved.

For the immediate future, January is key to SCCR as OnCore goes live in the Department of Medicine. As Spectrum’s Shulaker says, “We are definitely generating a lot of interest among people in other divisions and other departments. There’s a recognition out there in the research community that something like this is needed.”

Stay tuned for timely updates.