Dec. 2006 / Jan. 2007 | The biopharma industry has made considerable progress in the execution of clinical studies, in part by improving the collection of patient data. But while an estimated 27 percent of clinical research is conducted using electronic data capture (EDC), those data must be transcribed into the EDC system from disparate sources, including paper records and electronic medical records (EMR)/electronic health records (EHR) systems. This constitutes a wasteful duplication of effort for study site personnel, which could be addressed by the fusion of EHR and EDC.
Unfortunately, EDC and EHR systems cannot substitute for each other. The sponsor’s EDC system cannot be used as the only source for the data because regulations require that the investigator be responsible for the source data. EHR systems are not required to follow the stringent regulations of clinical research, hence are not currently appropriate as the sole collection agent for clinical data.
Increasingly, the sites conducting clinical trials using EDC have EMR/EHR systems that require much of the same patient data. EMR data are often unstructured, and the number of different EMR/EHR systems and architectures make it difficult and costly to integrate with EDC. The result is often the creation of several overlapping records of information — the paper medical chart; the same data in the EMR/EHR system; printouts for transcribing the data to EDC; and the EDC record. This increase in redundancy and cost will only get worse as electronic data sources increase, i.e., as regions, states and countries moves towards an eHealth environment.
This is currently a “hot topic” in biopharma data management circles. The eClinical Forum, in conjunction with the PhRMA EDC/eSource Taskforce, spent two years discussing this topic and released a white paper on the ways that clinical research can tap into these systems, avoid duplication, and comply with government regulations and guidelines . The CDISC Electronic Source Data Interchange (eSDI) group has also published a paper on electronic source data.
The Current eHealth Environment
EHRs (more encompassing summary record than traditional EMRs) are considered by government agencies, payers, healthcare providers, and the clinical research community as a quantum leap forward in delivery of their respective needs. The growth of EHR in hospitals and physician offices means that patient data are increasingly being entered and maintained electronically. Recent reports suggest that 20-25 percent of U.S. healthcare practices use EMR/EHR systems. (In Scandinavia, the figure approaches 90 percent.)
Healthcare in general is under tremendous time and cost pressures. Patient records predominantly serve the purpose of the medical care of the patient and are optimized towards this purpose. It would be inefficient and costly for a hospital or physician’s office to carry out the meticulous documentation that is common in the biopharma industry unless the EHR system is designed to handle those tasks “behind the scene.” Substantial redevelopment of EMR/EHR products on the market may be required to meet the needs of both healthcare providers and clinical trial personnel. Without encouragement and incentive, adoption of such regulations and clinical research requirements within EHR could be unattainable.
The ideal environment would comprise non-redundant systems and processes that allow the use of patient electronic medical data for clinical research in a way that meets data protection, regulatory, and ethical research requirements and minimizes the challenges of clinical research for healthcare professionals. Regulators need to look at requirements for clinical research with an eye for what is appropriate in this new world of e-source. eHealth designers need to consider the value in incorporating clinical research within National eHealth initiatives. Only by working together can both healthcare and the pharmaceutical industry realize the joint goal of bringing the best possible care to all individuals.
The following points are critical to realize the potential of this new environment and need to be considered:
• Mechanisms to utilize electronic medical information to support both routine treatment and research purposes while satisfying regulatory and research requirements.
• Collaboration on common data standards (including EHR narratives) and data transfer standards to support both national health record and clinical research needs (e.g., support for the CDISC/HL7 joint initiative). Data standards are essential for data collection, interpretation, and exchange within and between the medical and research communities.
• Controlled, secure processes for releasing and transferring data from and to the EHR and research systems that are consistent with personal data privacy, clinical trial regulations, healthcare delivery regulations, and bioethical considerations.
• Collaboration between the bio-pharmaceutical and healthcare industries and associated vendors to expand and adapt the structure of EHR and the associated systems, networks, and processes. This includes the development of a standard EHR application interface or portal.
This is just the tip of the iceberg. Formal discussion of biopharma requirements in the eHealth planning stage is essential. Bringing bio-pharmaceutical requirements to the table with government eHealth designers in the US, EU, and around the world is the beginning of the necessary fusion of EHR and EDC.
Further reading: “The Future Vision of EHR as eSource for Clinical Research” released by the PhRMA EDC/eSource Taskforce and eClinical Forum, , at: www.eclinicalforum.com.
John Mestler is a member of the eClinical Forum and PhRMA EDC/eSource Taskforce. Email: firstname.lastname@example.org
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