PACeR, which is a collaborative of leading medical research centers, pharmaceutical companies, and HIT organizations, is working to create an electronic clinical data process for evidence-based research in New York State that it hopes will make needed therapies available to patients faster.
The organization said Tuesday that the projects will involve multiple academic medical centers and will demonstrate the capability to provide protocol modeling input across many institutions. Pending funding, projects under consideration include:
-- a statewide "Center for the Support of Clinical Terminology and Ontology Mapping" to oversee use of a common set of standards by participating institutions.
-- deliver protocol modeling and patient selection services using data from multiple institutions.
-- data aggregation and reporting capability to support the "one-stop shop" role of delivering analytical services spanning multiple institutions.
-- deploy clinical software systems that "wrap around" currently deployed EMR systems, where those systems will not accommodate the capture of data required for clinical research.
-- public education about the responsible use of personal clinical information for the treatment and cure of disease and for the development of new diagnostics, medications, and medical devices.
"Oracle is committed to being part of PACeR's groundbreaking work aimed at creating a sustainable, electronic clinical research data network in New York to support more efficient and effective clinical trial participant recruitment," Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences, said in a statement. "The group's Phase 1 findings confirm the feasibility of such a network and define a clear path forward. Oracle looks forward to continuing to work as part of PACeR to advance this important initiative."
The plan outlined for Phase 2 builds on work that began in 2010. PACeR's first phase of work validated the feasibility of developing a statewide clinical data process for evidence-based research and offered the opportunity to improve existing electronic medical record (EMR) utilization and patient health data confidentiality.
The organization noted that its research has confirmed that fewer protocol amendments and more rapid patient recruitment and enrollment can result in earlier, less expensive product launches, and significant benefits to patients from earlier access to innovative therapies. PACeR's revenue potential for clinical study protocol modeling alone is substantial: more than $50 million annually.
PACeR Phase 1 estimates show that for an average protocol, modeling, and amendments, savings will range from $100,000 to $200,000 per protocol and cost reductions associated with trial conduct will range from $400,000 to $500,000, the organization said.
Daniel Sisto, president of the Healthcare Association of New York State said medical research is experiencing rapid change and the PACeR collaborative is at the forefront of revolutionizing how medical research is conducted and how the benefits of this research are shared. A white paper describing PACeR's Phase I results and Phase 2 plans is available online.
In the new, all-digital InformationWeek Healthcare: iPads are leading a new wave of devices into the exam room. Are security, tech support, and infection control up to the task? Download it now. (Free registration required.)