New initiative aims to speed clinical research, cut cost
The Partnership to Advance Clinical electronic Research (PACeR) has launched a new initiative that aims to make clinical trials faster and less expensive by identifying potential candidates more efficiently and improving protocol modeling and data collection.
To that end, PACeR is working to create an electronic clinical data process for evidence-based research in New York State.
By testing and making needed therapies available to patients faster, PACeR says it will help improve the quality of life for patients.
New model for research
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 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 healthcare stakeholders, including patients, academic medical centers, the research community, health information technology companies, regulators, public and private initiatives, and the State of New York.
What 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 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,” said
HANYS’ president, Daniel Sisto. “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.”
“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,” said David A. Krusch, MD, CMIO at the,University of Rochester Medical Center, and chair of the PACeR Governing Group. “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.
A white paper describing PACeR’s Phase I results and Phase 2 plans is available online.