A partnership of academic medical centers, pharmaceutical companies, information technology firms and other stakeholders has begun an initiative to establish an electronic clinical research network in New York, which could eventually be extended across the country. The network would use data from electronic medical records (EMRs) to increase the speed and quality of clinical studies while at the same time reducing costs.
The collaboration, known as the Partnership to Advance Clinical electronic Research (PACeR), wants to create a standardized platform that could use EMRs from multiple institutions to identify patients for clinical trials, develop study designs that require fewer protocol amendments and collect data about the long-term safety of drugs.
“PACeR brings tremendous opportunities to enhance the entire clinical trials research process, from study design and patient identification to the actual conduct of the trial itself,” said David Krusch, M.D., chair of the PACeR governing group and chief medical information officer at the University of Rochester Medical Center.
In developing an infrastructure to support its electronic clinical data network, PACeR envisions what it calls a “federated” database approach, by which participating organizations would continue to own and control access to their data. PACeR would then allow database queries across the “federation” to conduct specific analyses. In the long-term, PACeR envisions its organizations sharing clinical data for the full range of scientific evidence-based research, including outcomes, epidemiology, comparative effectiveness and safety surveillance, not just in New York state but across the country.
“We view multi-stakeholder collaborations, like PACeR, as an important driver of research and development productivity that will ultimately bring important medicines to patients around the world,” said David Leventhal, director of Healthcare Informatics at Pfizer and a PACeR committee member.
The group plans to demonstrate the potential use of EMRs in clinical trials, such as in protocol modeling and patient recruitment, through a series of projects this year involving participating hospitals, academic centers, technology companies and the pharmaceutical industry. The projects, which will help build the infrastructure needed to establish a statewide, standardized clinical data network to be used for evidence-based research, include developing a common language for disparate EMR systems, exploring patient privacy issues and developing clinical software that can capture data necessary to meet FDA requirements for clinical studies.
The projects build on a feasibility study conducted by a PACeR work group during the past year that examined the legal, economic, regulatory and technical barriers to using electronic patient data in clinical research and proposed a plan to address those challenges. For example, the study found that existing EMR systems, which usually capture only summary information for basic medical charting and billing purposes, are unable to capture all of the patient-specific clinical data needed to conduct research. In addition, disparate EMR systems lack the ability to share information or allow the conduct of scientifically valid comparative research. These concerns will be addressed as the initiative moves into its next phase.
“The group’s phase I findings confirm the feasibility of such a network and define a clear path forward,” said Neil de Crescenzo, senior vice president and general manager at Oracle Health Sciences, which is participating in the initiative.
In its feasibility study, PACeR estimated that using data from the network could save drug sponsors up to $500,000 on an average clinical trial, primarily from more rapid identification and enrollment of patients. To the extent that rapid enrollment in New York State allows an earlier product launch, PACeR estimates tens of millions of dollars in benefits based on reducing the lead time from 48 to 36 months. In addition, savings from improved clinical trial modeling and a reduced need for amendments could range from $100,000 to $200,000 for an average protocol.
PACeR was created under the auspices of the Healthcare Association of New York State (HANYS) and includes global pharmaceutical companies, patient representatives, clinical research organizations, technology companies, hospital and ambulatory care networks, physicians and patients. As it moves forward, PACeR has encouraged the participation of additional members, such as physician professional societies, community hospitals, device manufacturers, EMR vendors and disease societies.
“The PACeR collaborate has proven that bringing together diverse stakeholders is an effective approach to finding ways to improve clinical trials using electronic data,” said HANYS President Daniel Sisto. “HANYS looks forward to continuing this important work, which promises to help speed new, effective treatments to patients while improving the efficiency of the entire clinical trial process.”