Mining for Trial Participants

Mining for Trial Participants
Ted Agres, Contributing Editor
Drug Discovery & Development - October 01, 2010

Fifteen academic medical centers, research institutes, and major pharmaceutical companies are collaborating to enhance the speed and quality of clinical trials by harnessing patient data emerging from the coming widespread adoption of electronic health records (EHRs).
The goal of the Partnership to Advance Clinical Electronic Research (PACER), announced in June, is to allow researchers to mine medical records and other clinical databases created by physicians and hospitals in New York State while giving drug manufacturers and contract research organizations the ability to identify and recruit qualified patients for clinical studies.
Through PACER, “we will improve the modeling and design of clinical trials, the selection of patients, the speed with which clinical trials are conducted, and the probability of success of bringing new drugs to market” said John Murphy, PhD, head of clinical analytics at Quintiles, Research Triangle Institute, N.C.
“As we gain a deeper understanding of patients, disease-states, and therapies, we will be better able to design clinical trials and understand clinical end-points that will demonstrate efficacy of new therapies and ensure the safety of drugs,” Murphy told Drug Discovery and Development.
The PACER collaborative is being developed by the Healthcare Association of New York State. Participating academic centers include the Columbia-Cornell Medical System, the New York University Medical System, and Mount Sinai Medical School. In addition to Quintiles, major industry participants include Pfizer Inc., Merck & Co. Inc., Johnson & Johnson, Bayer AG, Boehringer Ingelheim, and Medco Health Solutions Inc. Internet giant Google Inc. will provide Web-enabled mechanisms for the secure access of medical data and other records across multiple platforms.
When implemented in 2013, the system is expected to store medical information from at least 50 million patients. And it if proves successful, PACER could be rolled out to other states and perhaps internationally.
Making ‘meaningful use’
Most academic medical centers, hospitals, and large physician practices already maintain electronic medical records of patients. But the usage tends to be sporadic and information is often stored in proprietary formats. Many experts believe that the widespread adoption of standardized EHRs with interchangeable data will reduce overall healthcare costs and improve overall quality of care. Starting next year, the federal government will pay doctors and hospitals bonuses for using certified electronic health records in their practices. Upwards of $27 billion will be given out over the next six years to those who make “meaningful use” of these records.
PACER aims to capitalize on the expected growth of electronic medical records by creating a single-entry clinical system to capture data. The system will offer Web-enabled access to a centralized clinical data network as well as real-time decision support and advanced clinical analytical tools, Murphy said in a white paper describing the project.
Here’s how PACER will work: A “siloed” set of electronic repositories containing clinical study data will be created alongside participating institutions’ databases. Because data will be fed simultaneously into both the patient care and clinical study systems, the need for a dedicated clinical trials management system will be eliminated.
Another system will house de-identified and “sharable” data along with non-proprietary disease-state, therapeutic, and economic information. This third system could be used for general clinical and public health research. Data from a variety of public and subscription databases could also be added, including from medical and molecular biology libraries and financial and government agency data sources.
Clinical and research scientists will be able to access these systems by constructing data capture rules for patient, disease, or therapeutic research. Physicians will be able to access the system in real time while meeting with their patients.
Challenge of clinical trials
Limited access to standardized data is one of the main reasons clinical trial enrollment is so time-consuming and expensive. Even after patients are enrolled, many are found to be ineligible. Others withdraw due to geographic limitations or financial issues. And as patients drop from trials, new patients must be recruited, causing further delays and increased costs.
“Clinical research is one of the most critical aspects of getting innovative medicines to patients. It has been extremely challenging to conduct high-quality clinical research on a timely basis,” said David Leventhal, director of healthcare informatics at Pfizer, a member of the collaborative.
PACER may help change this. Those planning clinical trials can enter specific enrollment requirements. When patient information that potentially matches the criteria is entered, the system will automatically alert the treating physician or clinician at the point of care and provide educational material and consent information for the patient to consider. If the patient chooses to enroll in the trial, the system will drive diagnostic protocols until a final eligibility decision is made.
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and other state and federal agencies are serving as advisers, Murphy said.
PACER will develop over the next 3 to 4 years. The first phase involves developing functional specifications, legal and regulatory frameworks, and business models. The second phase involves building, deploying, testing, and validating a state-wide clinical care and research system prototype. In the final stage, the system will be expanded to include other healthcare institutions in the state and additional pharmaceutical companies.
“Through a unique reuse of data collected during the delivery of care, the PACER project will create processes to accelerate the identification of clinical trials subjects for investigational drug trials and potentially streamline and enhance the actual conduct of the trials themselves—all while preserving the privacy and confidentiality essential to any electronic health record implementation,” said David A. Krusch, MD, chief medical information officer for Strong Memorial Hospital and chair of the PACER Governing Group.
About the Author
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences