While much of the attention regarding the use of electronic health records centers on improving patient safety and outcomes, the pharmaceutical industry also sees an opportunity for EHRs to help improve clinical research.

An example of this is the recently formed Partnership to Advance Clinical electronic Research, or PACeR, in New York. The collaborative effort includes representatives from pharma (Pfizer, Merck and Johnson & Johnson), Quintiles, New York academic medical centers, the Healthcare Association of New York State, the Hastings Center and the Legal Action Committee. Also participating in this group are FDA and standards-setting bodies Clinical Data Interchange Standards Consortium and Health Level-7.

PACeR's overall goal includes "collaboratively working together to really put together the operational framework that would allow the state to adopt electronic health records in ways that are not only advantageous and better for patient care, but also make it possible for the conduct of clinical research through those academic medical centers," David Leventhal, director of healthcare informatics at Pfizer, said in an interview.

Leventhal added a more specific interest from pharma's perspective: better trial protocols as well as a stronger capability to match patients with appropriate clinical trials.

"Our hope early on is to utilize de-identified patient data to better enable the more effective writing of clinical trial protocols and to make site selection decisions based on an epidemiological framework where we potentially see [a large number] of patients," Leventhal said. He acknowledged that it is ultimately up to the principal investigator and physicians within the academic medical centers to handle the actual recruitment for studies.

Simon Sinclair, a senior director at Merck, said in an e-mail to "The Pink Sheet" that EHRs "have the potential to provide us with large quantities of data - but currently the usefulness of those data is limited by patchy coverage and limited access. The universalization of EHRs will mean that clinical data capture for drug research will become part of the standard clinical physician-patient encounter and data will be entered into a single system. ... The richness of the data set, both at the patient level and at the population level, has enormous benefits for tailoring pharmaceutical development and conducting individual clinical trials."

Use of electronic medical records is expected to expand with financial incentives for adoption that are provided by the government under the American Recovery and Reinvestment Act (¹ Also see "Adoption Of E-Health Records Gets Stimulus Of Medicare Rewards, Penalties" - Pink Sheet, 2 March, 2009.).

Sinclair noted that Merck sees PACeR "as an innovative opportunity to partner with other key stakeholders in the first significant U.S. project to address the integration of an eClinical capability with an existing government-funded health information network. It will allow us to design better clinical research programs that more closely fit with patients' normal engagement with health care providers, and which more thoroughly address their needs and those of their doctors."

In a June 16 announcement of the formation of PACeR, the organization noted that participants will "seek to streamline and accelerate clinical research processes by providing an improved clinical network approach to support evidence-based drug studies."

PACeR called itself the "first coordinated effort to improve timeliness and maximize research capacity through enhancement and availability of standardized data and research protocols."

Privacy, Other Issues Abound

Questions regarding patient privacy will be at the forefront when it comes to using EHRs for clinical research, particularly in clinical trial recruitment.

Speaking June 14 during a panel session at the Drug Information Association's 46 Annual Meeting in Washington D.C., Chesapeake Research Review CEO Felix Khin-Maung-Gyi raised some issues related to privacy.

"I am trying to wrap my mind around ... using electronic health records to sort of do the screening to find an appropriately eligible population" for clinical trials, Khin-Maung-Gyi said. "It seems to me that, in keeping with both ethical controls as well as regulatory requirements, we would need to have consent of a large number of people before something like this can be adequately and appropriately accomplished."

Ethan Basch, oncologist and clinical researcher with Memorial Sloan-Kettering Cancer Center, was not as worried about privacy.

"In my view, issues of privacy and data security, although very important, are lesser obstacles at the ground level and, in many contexts, you've seen these obstacles overcome," Basch said during the DIA panel.

Rather, he pointed to two other issues that could be problematic. From a clinician's standpoint, Basch said he is concerned about the efficiency of entering data into electronic records. "I don't have time for double data entry. Many clinicians feel they don't have time for single data entry, and this has really been a problem in getting clinicians or clinical staff to provide data from multiple sources, particularly when there are several variations in the data elements being required."

From a researcher perspective, "the biggest problems I see are standardization of vocabularies and interoperability," Basch added. "My observation has been as EHRs have proliferated at sites involved in these various clinical trial networks, because of variable standards and lack of interoperability and the expense associated with building interfaces, it has become more challenging to collect data from sites, rather than less challenging."

Basch said he hopes some of these issues will be sorted out as the Office of the National Coordinator for Health Information Technology continues its progress toward developing the standards that will be used to determine "meaningful use" of electronic health records (² Also see "Health IT Strategic Framework Aims To Create A "Learning Health System"" - Pink Sheet, 29 March, 2010.).

- Gregory Twachtman ( ³ g.twachtman@elsevier.com )

Pharma Sees Potential For E-Health Records To Improve Clinical Research

More from Archive

More from Pink Sheet