Stanford Center for Clinical Research: The Engine That’s Powering Clinical Research
The Stanford Center for Clinical Research (SCCR) is the “operational engine” that enables many faculty throughout Stanford to drive robust clinical research enterprises, according to Kenneth Mahaffey, MD, professor of cardiovascular medicine, vice chair of clinical research in the Department of Medicine, and director of SCCR.
Since its inception in late 2014, SCCR has grown to 70 staff and partnered with more than 50 faculty and 25 fellows on 82 research projects.
SCCR has three foundational enterprises:
- A site-based research program led by Rebecca McCue to support projects in which Stanford researchers enroll Stanford patients in clinical trials.
- A coordinating center led by Amol Rajmane, MD, to help design and conduct multicenter registries, trials, and outcome programs.
- An educational component led by Kiera Larsen, RN, which has created preceptorships and a large portfolio of educational opportunities — including scientific seminars and Good Clinical Practice workshops for research staff — and educational events for industry.
Supporting Faculty across the School of Medicine for Site-Based Research
SCCR works with faculty to understand research interests and then develop their research portfolios to support the desired vision. SCCR hires, trains, manages, and mentors research staff to navigate complex processes, letting faculty focus on their scientific and clinical care activities.
“SCCR doesn’t remove the faculty member from the key relationship with research coordinators, but we take on a lot of the administrative burden,” McCue, the associate director for SCCR’s site-based research projects, points out.
In just a few years, SCCR’s partnership with the division of gastroenterology and hepatology has helped the division’s research portfolio grow from 10 studies to more than 50. The SCCR team works with 22 principal investigators and 11 dedicated research staff in the division. Key achievements for the division include: collaboration with the Research Management Group to determine the appropriate funding for studies, a streamlined budgeting and contract process that has led to earlier initiation of studies, improved financial metrics, the adoption of a central Institutional Review Board process, and a culture of collaboration and efficiency.
SCCR teams support many types of research — drug, medical device, and mobile/digital technology trials; investigator-initiated studies; and multisite registries. Investigators collaborate across divisions and departments in the School of Medicine, with groups such as neurosurgery; vascular surgery; radiology; biodesign; athletics; infectious diseases; and Spectrum, the Stanford Center for Clinical and Translational Research and Education — furthering a holistic and multidisciplinary approach.
Sanjiv (Sam) Gambhir, MD, PhD, professor and chairman of radiology, helped launch Project Baseline, one of the largest projects that SCCR works on. Project Baseline is a collaborative effort among Stanford Medicine, Duke University School of Medicine, Verily, and Google. The researchers plan to enroll approximately 10,000 participants with an extraordinarily detailed evaluation of each participant; the idea is to characterize what it means to be healthy and to capture changes during a transition to disease.
“A large part of Project Baseline deals with trying to understand the transition from health to disease on a personal level, which integrates precision medicine, preventive health, and mobile and digital technologies,” Mahaffey says.
To help with study recruitment, SCCR leaders launched a Community Advisory Board for Clinical Research in 2015, which allows faculty to engage community members as partners. The aim of the advisory board is to bridge the gap between researchers and the community to enhance clinical research.
Multisite Research Project Coordination
SCCR’s Coordinating Center helps faculty design and run multisite research projects, as its project managers provide input on protocols, assist with FDA and Institutional Review Board submissions, shape sustainable study budgets, and manage sites. It also offers core lab administration, safety desk work, event adjudication, and data safety monitoring committee management.
The Apple Heart Study, conducted to learn if an app can use data from the Apple Watch to identify irregular heart rhythms, is one example of how SCCR works with Stanford researchers and sponsors to leverage technology and innovation to rigorously test drugs, devices, and other interventions.
“We have a portfolio of five studies relating to mobile and digital technologies created in part by an intense interest in these technologies by many Stanford faculty and by a strategic partnership with the Center for Digital Health,” says Rajmane, SCCR’s associate director for the Coordinating Center.
The Coordinating Center is also managing the research operations for a study evaluating concussions using an innovative mouth guard with local high school football programs. Partners include leading concussion experts from Stanford: bioengineer David Camarillo, PhD; neurosurgeon Gerald Grant, MD; and neuroradiologist Michael Zeineh, MD, PhD.
Every clinical research project involves tasks like project management, site start-up and initiation, oversight for recruitment and retention, data collection, core lab activities, safety event reporting, and quality and compliance oversight. For faculty who want to lead multicenter clinical research projects, SCCR eliminates the need to outsource those tasks.
“Faculty can lead these large projects without worrying about the operational administration and coordination, and as the activities are performed by a Stanford team and not by an outside entity, it’s easy for them to coordinate and work with the team. Faculty can have a much higher profile in these projects because all the research activities are being done here at Stanford,” Mahaffey says.
David Maron, MD, a clinical professor of cardiovascular medicine, notes how SCCR is readily available to round out his research team by helping complete proposals. He recalls an instance when a research application required detailed information about a committee to adjudicate clinical events and notes how “SCCR provided a description of the organization, the budget, and the personnel that was required in the application.”
Partnerships and Team Science
“We work with these resources to understand how to oversee new types of research protocols to make sure processes are appropriate. We want them to adhere not only to institution policies and standards, but also to external requirements from the FDA and NIH,” he says.
“Working with SCCR has been seminal to my career progression. I’ve had the privilege of working with Ken [Mahaffey] and his outstanding team for over four years now on a series of clinical trials that range from traditional small, single-center trials all the way to the Apple Heart Study, a massive virtual clinical trial. In the early days of SCCR, it was a handful of us working together — much like a startup — to get the job done. Now the group has about 70 people and is a remarkably well-oiled machine,” Turakhia says.
SCCR is involved with faculty who are experts in a variety of therapeutic subjects and areas of practice. “We have projects that really epitomize team science, with faculty from multiple disciplines and research staff from multiple areas, including data scientists, project managers, information technology experts, biostatisticians, and bioinformaticians,” Mahaffey says.
He describes how SCCR’s activities over the past four years speak to its mission of “conducting and promoting high-impact, innovative clinical research to improve human health.”