The industry is always seeking new ways to improve the timeliness and accuracy of clinical data. Now, with the increasing adoption of Electronic Health Records (EHR), extracting clinical data directly from the site’s EHR system has become a viable option.
The benefits are many:
- The site uses its own familiar interface and the study coordinator does not need to learn a new program.
- Because the data is taken directly from the patient’s record, data collection is faster and source data verification is eliminated.
- Data that are not normally collected in the site’s EHR, can be collected on eCRFs that are displayed within the EHR interface.
Nextrials is an early implementer of the relevant CDISC standards and has already demonstrated interoperability with a number of EHR systems. This linkage with EHR can also be used to facilitate spontaneous safety reporting for marketed therapeutics.
Nextrials has built its EHR integration tools around standards co-developed by Clinical Data Interchange Standards Consortium (CDISC) and Integrating the Healthcare Enterprise (IHE). We support these standards because we believe the industry benefits from participation by multiple vendors. Nextrials is the only clinical research software provider who has earned the recognition of CDISC Registered Solution Provider for the Healthcare Link Initiative, the standards behind EHR integration. (See list of providers here .)
Adherence to these standards, allows us to build one integration that works with all EHR systems that support the standard. Nextrials has already demonstrated the validated exchange of data with the following EHR systems:
Since 2009, Nextrials has participated every year in the annual implementation and testing forum called the Connectathon and is the only e-clinical software provider to do so. During this event, Nextrials has passed all required test and validation plans for the EHR integration efforts. This has qualified Nextrials to participate in the InterOperability Showcase at the annual EHR conference sponsored by the Healthcare Information and Management Systems Society (HIMSS). This showcase features over 100 stakeholders across all areas of healthcare sharing information between their domains. Nextrials can utilize this network of healthcare interoperability to benefit your clinical programs.
Data Collection – E2E™ Tool
The Nextrials E2E™ tool extracts clinical data directly from the EHR, which streamlines the data collection process and improves data quality. The FDA issued a guidance covering the use of EHR systems for clinical trials that notes the following benefits:
- Eliminate unnecessary duplication of data
- Reduce the possibility for transcription errors
- Encourage entering source data during a subject’s visit
- Eliminate transcribing source data before entering the data into an EDC system
- Promote real-time data access for review
- Ensure the accuracy and completeness of data
* Guidance for Industry – Electronic Source Data in Clinical Investigations, Draft November 2012
Data that is not collected in the EHR can still be entered into the CRF from within the EHR. The site user never has to leave the EHR system! Even data queries can be processed within the site’s EHR.
Nextrials, in collaboration with Greenway Technologies, conducted a multi-site study where over 75% of the data was extracted from the site’s EHR. The project was published in peer-reviewed article in Applied Clinical Trials. Read article.
The same standards and tools used for data collection can also be employed for pharmacovigilance. EHR integration enables significant improvement in the process for reporting serious adverse events since much of the data needed for safety reporting is already captured in the EHR. In a seminal project named ASTER initiated by Pfizer with Partners Healthcare, the following results were achieved:
- Completion of MedWatch form went from 36 minutes to less than 1 minute.
- No completion instructions were needed.
- Even though 91% of participating MDs had not submitted a safety report the prior year, participants averaged 5 reports in a 3 month period.
- All participants submitted at least one safety report.
- The project was well received by the physicians.
This technology, particularly if implemented across a large site network, would provide powerful post-marketing safety data for regulators and sponsors and could become part of a company’s Risk Evaluation and Mitigation Strategy (REMS).
- FDA: Electronic Source Data in Clinical Investigations – Draft Guidance
- EMA: Reflection paper on expectation for electronic source data and data transcribed to electronic data collection tools in clinical trials
- CDISC Healthcare Link Initiative
- CDISC Healthcare Link Profiles
- CDISC Healthcare Link Chapter
- CDISC Healthcare Link Registered Solution Providers
- IHE Retrieve Form for Data Capture Standard
- HL7 EHR Clinical Research Functional Profile (CRFP)
- Endorsement by HIMSS Electronic Health Record Association
- EHRCR Functional Profile Project
- 2014 ACDM Conference: EH4CR
- Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) Certified for Clinical Research June 2011
- Partnership to Advance Clinical Electronic Research
- Applied Clinical Trials: EDC & EHR Integration – Lessons learned along the journey to merge electronic platforms in clinical research and healthcare.
- CenterWatch Monthly: EHR integration could change the game for clinical research
- AMIA: Interoperability Review: EHRs for Clinical Research
- Clinical Leader: Integrated Clinical Trial/Electronic Health Record Platform – Prism
- Drug Discovery & Development: Integrated EDC/EHR Platforms for Clinical Trial Research
- eCliniqua: Four Ways an Integrated EDC/EHR Platform Can Boost Your R&D Efforts
- Clinical Leader: 5 Reasons for Using Integrated EDC/EHR Platforms
- Accenture Survey: EMR and HIE Use Increases Among U.S. Doctors