Collaborative to Speed Clinical Research and Reduce Costs

May 24, 2011 ALBANY, N.Y. - The Partnership to Advance Clinical electronic Research (PACeR), a broad-based health care collaborative, aims to make clinical trials faster and less expensive by identifying potential candidates more efficiently and enhancing protocol modeling and data collection. To achieve this, PACeR is working to create an electronic clinical data process for evidence-based research in New York State.

Most importantly, by testing and making needed therapies available to patients faster, PACeR will help improve the quality of life for patients.

A Strong Model with Benefits for All Stakeholders

Launched in 2010, PACeR's first phase of work confirmed the feasibility of developing a sophisticated, statewide clinical data process for evidence-based research and offered a plan to address the challenges and improvement opportunities associated with the design of existing electronic medical records (EMRs) and patient health data confidentiality.

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.

PACeR's Phase 1 results also point to significant benefits for major health care stakeholders, including patients, academic medical centers, the research community, health information technology companies (HIT), regulators, public and private initiatives, and the State of New York.

A white paper describing PACeR's Phase I results and Phase 2 plans is available online at www.pacerhealth.org.

Who Is PACeR?

PACeR is a collaborative of leading medical research centers, pharmaceutical companies, and HIT organizations. Participants include:

* Sponsor: Healthcare Association of New York State (HANYS)
* Patient Advocacy Groups: The Hastings Center and Legal Action Center
* Academic Medical Centers: Albany Medical Center, Bassett Medical Center, Continuum Health Partners (St. Luke's-Roosevelt Hospital and Beth Israel Medical Center), New York Hospital Queens, North Shore-Long Island Jewish Health System, NYU Langone Medical Center, Roswell Park Cancer Institute Corporation, Stony Brook University Medical Center, SUNY Downstate Medical Center, SUNY Upstate University Hospital, University of Rochester Medical Center, Weill Cornell Medical College, and Westchester Medical Center
* Clinical Research, Pharmaceutical, and HIT Organizations: Bayer HealthCare Pharmaceuticals, Inc., F. Hoffman-La Roche, Ltd., Johnson and Johnson, Merck & Co., Inc., Oracle, Pfizer, Inc., and Quintiles
* Project Management: Booz & Company and Quintiles Consulting

The guiding principle behind PACeR is the benefit to patients. Ensuring robust patient privacy and consent protections is paramount. Incorporating patient advocacy groups in PACeR's participation and governance ensures that their role and benefits are a top priority. PACeR will continue to ensure that all solutions deployed will allow patients to decide how their personal medical information will be used.
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HANYS' President Daniel Sisto said, "The rapid change we see in the health care system is also occurring in medical research, and the PACeR collaborative is at the forefront of revolutionizing how medical research is conducted and how the benefits of this research are shared. The PACeR collaborative has proven that bringing together diverse stakeholders is an effective approach to finding ways to improve clinical trials using electronic data. 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."

David A. Krusch, M.D., Chief Medical Information Officer, University of Rochester Medical Center, and Chair of the PACeR Governing Group, commented, "PACeR brings tremendous opportunities to enhance the entire clinical trials research process; from study design, patient identification, to the actual conduct of the trial itself. Most importantly, PACeR not only facilitates clinical research, but in doing so it brings new and novel therapeutic opportunities to patients who may never have had such options if not for this new and exciting technology. One can think of PACeR as introducing a new era in the development of dramatic increases in quality of care."

PACeR's Next Phase: Building Infrastructure for Enhanced Clinical Research

PACeR is currently soliciting funding for Phase 2, to begin demonstration projects to develop the infrastructure needed to advance more efficient and effective clinical research. Consistent with PACeR's objectives, the projects will all involve multiple academic medical centers to 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 solutions 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.

"Pfizer, Inc. remains deeply committed to the PACeR Collaborative as a novel means of advancing new therapies through the long and complex process of Clinical Development," said David Leventhal, Director, Healthcare Informatics at Pfizer, and PACeR Project Leadership Committee member. "We further 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."

PACeR will continue to engage the full range of stakeholders, including practicing physicians and patients who will be affected by, and will benefit from, PACeR.

"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," said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. "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."

Rebecca Kush, Ph.D., President and Chief Executive Officer of the Clinical Data Interchange Standards Consortium (CDISC), stated, "As the leader of an organization that is dedicated to improving the clinical research process, I applaud the PACeR goals and efforts in this direction. I look forward to continuing as an advisor on this project and to potential synergies in the activities of PACeR and CDISC to provide innovative means for biopharmaceutical companies and medical centers to work together to better link research and care for the ultimate benefit of patients."
"Quintiles is excited about the progress made by PACeR toward speeding up clinical trials through more rapid patient recruitment and enrollment, and a reduced need for protocol amendments," said John Murphy, Head, Clinical Analytics in Consulting at Quintiles, and project manager for PACeR. "In addition to the benefit to patients of earlier access to innovative therapies, this could bring multi-million dollar savings to our biopharma customers as they work to respond to ever-changing conditions in the New Health, where managing risk is a constant."

New PACeR Participants Welcome

PACeR strongly encourages participation of additional members in Phase 2, and welcomes the perspectives of new members such as physician professional societies, community hospitals, device manufacturers, EMR vendors, disease societies, and others. The more comprehensive PACeR's membership, the more sustainable its approach becomes.

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