Regulatory feedback indicates that while a new indication for a marketed drug might be achieved through EHRs, first marketing authorization using data entirely from EHRs would most likely not be possible with current systems until validation studies are performed and reviewed by regulatory agencies.
The EHR could also be used to collect serious adverse events SAE that result in hospitalization, or to collect endpoints that do not necessarily require blinded adjudication e. Events that are coded for reimbursement e. The reliability of endpoint collection varies by region and depends on the extent of linkage between different databases.
Electronic Health Records, EHR Software Solutions
The success of these endeavors is connected to careful planning by a multi-stakeholder group committed to patient privacy, data security, fair governance, robust data infrastructure, and quality science from the outset. The next hurdle is to adapt the accrued knowledge for application to a broader base of clinical trials. Data quality and validation are key factors in determining whether EHRs might be suitable data sources in clinical trials. Concerns about coding inaccuracies or bias introduced by selection of codes driven by billing incentives rather than clinical care may be diminished when healthcare providers enter data directly into the EHRs or when EHRs are used throughout all areas of the health-system, but such systems have not yet been widely implemented [ 42 ].
Excessive or busy workloads may also contribute to errors in clinician data entry [ 43 ].
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Indeed, errors in EHRs have been reported [ 43 — 45 ]. Complete data capture can be a major barrier in regions, where patients receive care from different providers or hospitals operating in different EHR systems that are not linked. Consistent, validated methods for assessing data quality and completeness have not yet been adopted [ 46 ], but validation is a critical factor for the regulatory acceptance of EHR data.
Proposed validation approaches include using both an eCRF and EHRs in a study in parallel and comparing results using the two data collection methods. This approach will require collaborative efforts to embed EHR substudies in large cardiovascular studies conducted by several sponsors. Assessing selected outcomes of interest from several EHR-based trials to compare different methodologies with an agreed statistical framework will be required to gauge precision of data collection via EHRs. A hybrid approach has also been proposed, where the EHR is used to identify study endpoints e.
Validity should be defined a priori and should be specific to the endpoints of interest as well as relevant to the country or healthcare system. Proposed uses of EHRs for registration trials and methods for their validation will likely be considered by regulatory agencies on a case-by-case basis, because of the limited experience with EHRs for this purpose at the current time. Collaboration among industry sponsors to share cumulative experiences with EHR validation studies might lead to faster acceptance by regulatory authorities.
As noted above, mortality may be incompletely captured in EHRs, particularly if patients die outside of the hospital, or at another institution using a non-integrated EHR. Thus, methods to supplement endpoint ascertainment in the EHR may be necessary if data completeness is uncertain. Standardized endpoint definitions based on the EHR should be included in the study protocol and analysis plan. A narrow set of data elements for auditing should be prospectively defined to ensure the required variables which are contained in the EHR.
Early interaction between sponsors, clinical investigators, and regulators is recommended to enable robust designs for clinical trials aiming to use EHRs for endpoint ascertainment. Gaps in personnel training and education should be identified and specific actions to address training deficiencies should be communicated to regulators and in place prior to the start of the trial. The potential for delays in data access is an important consideration when EHRs are used in clinical trials.
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Similarly, coding may occur weeks or months after discharge. In nationally integrated systems, data availability may also be delayed. These delays may be critical depending on the purpose of data extracted from the EHR e. Patients may be treated by multiple healthcare providers who operate independently of one another.
This heterogeneity adds to the complexity of using EHRs for clinical trials, since data coordinating centres have to develop processes for interacting or extracting data from any number of different systems. Differences in quality [ 47 ], non-standardized terminology, incomplete data capture, issues related to data sharing and data privacy, lack of common data fields, and the inability of systems to be configured to communicate with each other may also be problematic.
Achieving agreement on a minimum set of common data fields to enable cross communication between systems would be a major step forward towards enabling EHRs to be used in clinical trials across centers and regions [ 48 , 49 ]. Privacy issues and information governance are among the most complex aspects of implementing EHRs for clinical research, in part because attitudes and regulations related to data privacy vary markedly around the world. Data security and appropriate use are high priorities, but access should not be restricted to the extent that the data are of limited usefulness.
Access to EHR data by regulatory agencies will be necessary for auditing purposes in registration trials. Distributed analyses have the advantage of allowing data to remain with the individual site and under its control [ 39 , 41 ]. Pre-trial planning is critical to anticipate data security issues and to develop optimal standards and infrastructure. For pivotal registration trials, patients should be informed during the consent process about how their EHRs will be used and by whom.
Modified approaches to obtaining informed consent for comparative effectiveness research studies of commonly used clinical practices or interventions may be possible [ 50 ]. A general upfront consent stating that EHR data may be used for research is a proactive step that may minimize later barriers to data access, although revision of existing legislation or ethics board rules may be needed to allow this approach. Patients and the public should be recognized as important stakeholders, and they can be advocates for clinical research using EHRs and improve the quality of EHR-based research if they are educated and engaged in the process and the purpose and procedures for EHR use are transparent.
Developing optimal procedures for ensuring patients that are informed and protected, balanced with minimizing barriers to research is a major consideration as EHR-based research advances. EHRs for use in clinical research need a flexible architecture to accommodate studies of different interventions or disease states. EHR systems may be capable of matching eligibility criteria to relevant data fields and flagging potential trial subjects to investigators.
Patient questionnaires and surveys can be linked to EHRs to provide additional context to clinical data. EHRs may be more suitable for pragmatic trials where data collection mirrors those variables collected in routine clinical care. Whether regulators would require collection of additional elements to support a new drug or new indication depends on the drug, intended indication, patient population, and potential safety concerns.
The sustainability of EHRs in clinical research will largely depend on the materialization of their promised efficiencies. Programs like the NIH Collaboratory [ 41 ] and PCORnet [ 39 , 41 ], and randomized registry trials [ 51 , 52 ] are demonstrating the feasibility of these more efficient approaches to clinical research. The sustainability of using EHRs for pivotal registration clinical trials will depend on regulatory acceptance of the approach and whether the efficiencies support a business case for their use.
To make the vision of EHRs in clinical trials a reality, stakeholders should collaborate and contribute to the advancement of EHRs for research. Professional bodies, such as the ESC, can play a major role in the training and education of researchers and the public about the potential value of EHR. Clinical trialists and industry must be committed to advancing validation methodology [ 53 ]. Investigators should develop, conduct, and promote institutional EHR trials that change clinical practice; such experience may encourage EHR trial adoption by industry and the agencies.
Development of core or minimal data sets could streamline the process, reduce redundancy and heterogeneity, and decrease start-up time for future EHR-based clinical trials.
The diagnosis for US electronic health records: Fatally flawed
Role and influence of stakeholders in advancing the use of electronic health records in clinical research. Electronic health records are a promising resource to improve the efficiency of clinical trials and to capitalize on novel research approaches. EHRs are useful data sources to support comparative effectiveness research and new trial designs that may answer relevant clinical questions as well as improve efficiency and reduce the cost of cardiovascular clinical research.
Initial experience with EHRs has been encouraging, and accruing knowledge will continue to transform the application of EHRs for clinical research. The pace of technology has produced unprecedented analytic capabilities, but these must be pursued with appropriate measures in place to manage security, privacy, and ensure adequacy of informed consent. Ongoing programs have implemented creative solutions for these issues using distributed analyses to allow organizations to retain data control and by engaging patient stakeholders.
Whether EHRs can be successfully applied to the conventional drug development in pivotal, registration trials remains to be seen and will depend on demonstration of data quality and validity, as well as realization of expected efficiencies. The CRT is a strategic forum for high-level dialogues between academia, regulators, industry, and ESC leadership to identify and discuss key strategic issues for the future of cardiovascular health in Europe and other parts of the world.
We acknowledge Colin Freer for his participation in the meeting.
coulobitcanscong.tk The opinions expressed in this paper are those of the authors and cannot be interpreted as the opinion of any of the organizations that employ the authors. Martin R. Jude Medical, and Pfizer. Juuso Blomster: Astra Zeneca employee. Sylvie Duclaux: None. Ian Ford: None.
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Fleur Fritz: None. Samantha Goldman: None. Salim Janmohamed: GSK employee and shareholder. Mark Leenay: Employee of Optum.