Message from Mark Cullen, MD
Senior Associate Vice Provost for Research, Senior Associate Dean for Research
As Stanford Medicine rallies around a new set of strategic goals and long range plans for the university, I’m excited to highlight the role of the School of Medicine’s Research Office in this inaugural Bulletin. The Research Office is leading the charge to enhance and strengthen our research enterprise in a way that will prepare us for the remarkable transformation underway in precision and population health research, the centerpieces of Stanford Medicine’s mission.
One area in which our portfolio of translational research strategies is expanding is in the rapid development of novel investigational drugs and interventions for first-in-human testing. To take advantage these new clinical interventions — from small molecules and biologics, to cell and gene therapies — our clinical translational research units are being upgraded, and more resources are being allocated to both fundamental discovery labs and advanced technology services.
Investments in biobanking and information technologies, coupled with the rapid explosion of technologies for analyzing genetic, “omic,” immune function and physiologic parameters, will allow Stanford researchers to extract evidence from the large amounts of digitized health data that we’ve been collecting over the last few years. Our Research IT (RIT) platform now contains troves of digitized data on our Stanford clinical population, while the Population Health Sciences platform has assembled numerous datasets of patients from around the country and world, linkable to administrative, transactional and environmental data, auguring new pathways of discovery.
In the past, the gold standard for translation happened something like this: Someone discovered a disease target in an animal, it was tested for safety in a few humans, then it was tested in thousands of subjects to see if the intervention works. This is a time-honored but expensive and slow approach that sometimes doesn’t factor in external determinants of health, such as diet or pollution.
In the future, you’ll see more health researchers looking at a big health data sets such as Google Baseline, saying, “Look at this amazing biological thing that happens when people are exposed to these factors or treatments.” Researchers may be able to use this observational data to go directly into large human trials. Or the observations might be so strong that they could be immediately folded into public health policy, without going to trials. Or perhaps an idea would go “back to the lab,” where the basic biological mechanisms underlying the observation could be studied with the hope of identifying an even better possible intervention. At the same time, such large observational data sets may lead to the recognition of “precise” opportunities to change health by social intervention or policy, potentially addressing some of the dreadful health disparities that the Office of Research considers “priority one.”
My job will be to make sure that Stanford has the infrastructure to take full advantage of these research opportunities. To help researchers access the best datasets, analytic tools and research-related services, we are currently beta testing the Stanford Data Science Resource web portal. From this site, researchers can also sign up for expert consultations in data management, study design, biostatistics, informatics, technology integration, and much more. To encourage strategic risk-taking and to lessen the legal and regulatory overhead that can slow down studies, the Research Office is strengthening support teams, as well as online resources that enable easier navigation of research regulations. For example, our Clinical Research Quality group is currently rolling out new training, mock audits, IND and IDE support and monitoring, and an updated library of Standard Operating Procedures to help you navigate through the ever-changing regulatory landscape.
At Stanford, we are uniquely positioned to usher in a new era of discovery, by leveraging our combined strengths in fundamental discovery and translational research, our access to a growing and world-class health system, and our expertise in innovation and entrepreneurship. I encourage you to read the rest of this bulletin to learn more about how the Research Office is helping make these dreams a reality.