The School of Medicine and Yale-New Haven Hospital are investing in an IT infrastructure that will facilitate cutting-edge clinical and translational research and ease the administrative burden for investigators. The new strategy involves a three-pronged approach to meet the needs of the clinical and research enterprises: electronic health records (EHR), a clinical trial management system (CTMS) and a clinical research data repository (CRDR).
On the surface, Yale's efforts to develop an informatics infrastructure that supports its clinical research enterprise are overdue; but in reality, the institution has been studying and devising strategies to address this issue for the past few years. Although implementation of the IT infrastructure took some time to move forward, it has moved quickly and is being carried out on schedule.
Historically, the technology available at the national level for managing clinical research data has been suboptimal, but there is now a much more competitive array of vendors offering systems to meet Yale's needs. The advantage of not being among the first academic research centers to adopt this type of technology is that it provides an opportunity to take advantage of lessons learned by other institutions.
The first major undertaking in Yale's informatics transformation was to purchase an enterprise-wide electronic health record (EHR) system that will serve patients and physicians across the Yale New-Haven health system. At the same time, such a record needs to be integrated with Yale's research enterprise. "Providing an optimum environment for conducting clinical and translational research is an important component of our vision, because a very large number of faculty members who conduct clinical research are clinicians who are doing it in the context of their practice, and even the physician-scientists are drawing patients from the clinical environment," said David J. Leffell, MD, CEO of YMG and deputy dean for clinical affairs for YSM. Leffell and other leaders across the medical campus are unanimous in their view that a well-implemented EHR is more than a technology to assist in the delivery of medical care; it is an opportunity to leverage patient information with the vast amount of knowledge available on the research side. The EHR is in effect a powerful tool for clinical and translational research.
Yale is now in the process of integrating Epic, the number-one vendor of integrated EHR solutions in the United States. Its broad range of features makes it an ideal choice for an EHR that will allow for greater collaboration between YSM and the hospital. Overseeing Epic's implementation are Daniel Barchi, chief information officer for YSM and Yale-New Haven Health System, and Steven Schlossberg, MD, a urologic reconstructive surgeon, who is the chief medical information officer for YSM and Yale-New Haven Hospital. Both have extensive experience implementing Epic in multi-hospital health systems.
Easing the Burden of Conducting Clinical Research
While Epic was selected with an eye toward its ability to serve Yale's clinical research needs, the second element in Yale's IT strategy was to implement a clinical research management system that would achieve a new level of sophistication and support for investigator-initiated research.
Following an in-depth evaluation process that included 22 vendors and involved 120 faculty members and staff, the IT team decided to use OnCore, a well-known and widely used clinical trials management system (CTMS) that has been successfully implemented in 36 institutions. OnCore will be centralized and customized to manage the large amount of data involved in the initiation and operation of clinical research. Huron Consulting Group was engaged to assist in implementing OnCore; oversee project management; and provide expertise in integration, configuration, and training.
Yale negotiated with the vendor to include components that will be a boon to research, such as the automated population of lab values, a biospecimen management system, and a demographic interface that connects to Epic. Down the road, future integration will encompass a number of such additional features as automated roadmap functions and automatic upload of data to SAS. These tools, which have not been available at Yale until now, are expected be of great benefit to investigators.
Clinical research is increasingly difficult to administer and costly to undertake due to complex compliance, financial and ethical issues. The OnCore platform spans the entire clinical research process, including protocol review, electronic data capture, and patient registries. It also supports patient safety procedures, clinical research operations, and reporting.
"These types of implementation have been standard for cancer centers for years, so I was very excited when I was asked to be the faculty leader for this project," said Thomas Lynch Jr., MD, director of the Yale Cancer Center. "I took the responsibility of choosing the right product very seriously—not just for cancer, but for all research at Yale. I think OnCore will take research to a whole new level." Lynch noted that filling Yale's research needs was the main focus in choosing OnCore, while its administrative capabilities—such as the safety auditing that is already being done—are viewed as back-end functionality.
Seamless integration of all components of clinical trial activity is crucial. Clinical trials are fraught with compliance, financial and ethical issues that make them increasingly complex to administer and costly to conduct. A Council on Governmental Relations Study found that each of 25 institutions surveyed faced increased costs for compliance activities at the rate of $3 million per year over a five-year period. Administrative duties also erode the time that investigators are able to dedicate to research.
The new CTMS system is expected to increase data accuracy: decrease collection time: improve FDA compliance: simplify quality assurance and safety auditing: allow for an easy transition to statistical analysis when studies are completed: and reduce administrative costs. In addition to new grants, many large data projects will better realize revenue through budgeting invoicing, and cost recovery.
Leveraging Data to Conduct Research
The development of a clinical research data repository (CRDR)—the third component of Yale's informatics initiative—is in the early stages of planning. YCCI and the IT leadership team are in the process of canvassing other institutions that have had Epic in place for the past few years and have well-developed repositories, in order to learn more about ways of leveraging data to conduct research. "This will be a valuable tool for collecting a large amount of clinical data that will be a goldmine for clinical and translational research projects," said Leffell. To envision how the new IT systems can expedite and expand clinical research, consider the following example:
A patient comes to YNHH with an acute heart attack. After undergoing an angiogram and lab work, a stent is put in. An investigator in cardiology has approval to conduct research on an acute phase reactant in males over 40 with acute MI and the patient is enrolled in the study. Blood is drawn and is stored in a freezer farm as part of the tissue management capabilities of the CTMS. The patient is discharged, but in the meantime, another investigator is examining the genetics of a certain type of hyperlipidemia. A database search for patients with a particular lipid profile finds the cardiac patient who fits the bill. The investigator extracts the dna from the blood sample and enters the genomics data into the genomics database and the CRDR. Five years later a particular gene is linked to an illness and another investigator wants to find all the patients that have a specific genetic profile in order to conduct a clinical trial, which is now accessible thanks to the IT infrastructure. "You can see how valuable it is to leverage all that data but if you cannot find it in one place, you may never be able to access it for maximum research benefit" said Leffell.
Building this informatics infrastructure has involved an unprecedented level of collaboration among physicians, nurses, informatics specialists, business professionals, and others from across the health system—many of whom are working together for the first time. It's clear that the new IT capabilities will ease the administrative burden on investigators and reduce the costs of conducting clinical and translational research. The new system will be even more instrumental, however, in translating research discoveries into clinical care.