A broad-based collaborative effort to enhance the speed and quality of clinical research through tools such as integrating trial recruitment processes with electronic health records has been launched in the US.
Sponsored by the Healthcare Association of New York State (HANYS), the Partnership to Advance Clinical electronic Research (PACeR) brings together academic medical centres in New York state with, among others, pharmaceutical companies and contract research organisations such as Pfizer and Quintiles, health information technology organisations, the Food and Drug Administration and standards-based organisations like the Clinical Data Interchange Standards Consortium.
Working closely with the medical centres, PACeR will “assess current data capabilities and leverage the opportunities presented to integrate clinical trial elements into electronic clinical records repositories”, HANYS said, adding that the collaborative programme will be “the first co-ordinated effort to improve timelines and maximise research capacity through the enhancement and availability of standardised data and research protocols”.
By re-using data collected during the delivery of care, the PACeR project will create processes to accelerate the identification of clinical trials subjects 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”, explained Dr David Krush, chief medical information officer at Strong Memorial Hospital in Rochester, US and chair of the PACeR Governing Group.
Limited access to standardised data means identifying eligible candidates to enrol into clinical trials is “a time consuming challenge”, HANYS noted. Even when patients are enrolled, they may ultimately be dropped from a trial “because of subsequent ineligibility findings, geographic limitations, or financial challenges incurred by patients for travel and time lost from work”.
By bringing together a broad spectrum of key healthcare stakeholders, “we can create accessible, affordable, and efficient statewide, Web-based clinical research systems”, commented John Murphy, head of the Clinical Analytics Practice in Quintiles’ Consulting Group.
Harnessing information technology and novel scientific tools in the service of medical product development and review has been “a central priority” for the US Food and Drug Administration, said Dr Leonard Sacks, acting director of the FDA’s Office of Critical Path.
“In tackling issues such as the role of electronic health records in clinical research, the potential to personalise medicine using bioinformatics, and the safeguarding of medical privacy, HANYS’ Partnership to Accelerate Clinical Electronic Research has embraced the task and we enthusiastically support their effort,” he added.
