Co-authored by: Prithviraj Radhakrishnan
Digital disruption has influenced almost every sector, including Clinical Research (R&D). Pharma companies are competing fiercely to improve their drug discovery efficiency while minimizing costs. Sponsors are struggling with outdated systems, which are neither product-agnostic nor process independent. With the old pen-and-paper system, research teams have to ask for patient records from other doctors, which hinders their ability to make an effective study (clinical trial). Sponsors have limited access to the clinical information that healthcare organizations are accumulating in their IT systems, which if available can be a boon in terms of improving their clinical study. With all these challenges in place, one can’t ignore the role of Electronic Health Record (EHR) in addressing them.
EHR is defined as an electronic platform that contains individual electronic health records for patients and is maintained by healthcare organizations and institutions. The EHR database is protected by biometric authentication. EHR has brought about a radical transformation in the Life Sciences sector in terms of ease of subject identification, reduction in trial error caused due to manual efforts, and improving overall Clinical Research process efficiency. The FDA’s recent guidelines on using EHR as eSource for Clinical Research has catalyzed sponsors to look for consulting services to analyze their current capabilities and gaps as well as help them throughout the journey for optimally leveraging EHR- Clinical Research Integrated platform. Our experience suggests that sponsors are looking for an EHR solution to integrate five key stakeholders: Doctors (Healthcare Practitioners, Investigators), Healthcare providers (Hospitals, Insurance Providers, Study Site), Pharmacy Retailers, Patients (Subjects) and Government body (Regulators). The same is needed to facilitate ‘End-to-End Streamlined Data Flow’ in a compliant manner for successful Clinical Research.
Clinical consultancy for provisioning- EHR Integrated Clinical Platform
The landscape of Clinical Research is changing rapidly. Sponsors are struggling with increasing complexity of the trials, strict regulatory restrictions, and pressures to reduce the process costs. Integration of EHR with the clinical trial system(s) will help the sponsors to address the mentioned challenges. The Clinical Research process revolves around four key stakeholders – Sponsors, Investigator, Subjects, and monitor. HCL business consulting services can help sponsors in establishing robust procedures to navigate through the complexities of integration by leveraging a Next Generation Clinical Platform (NGCP). This offers an opportunity to effectively use EHR systems data.
NGCP integrates Clinical Trial system with the external EHR to facilitate the Clinical research process. To improve the performance, the following are the analytics-based glimpses of the platform:
Protocol Feasibility Assessment: Use of standard criteria (parameters/programs) based on EHR datasets can help to have better protocol design. In this way, the sponsors can avoid having overly restrictive inclusion/exclusion criteria for the study. This will help in improving patient adherence by eliminating (avoiding) protocol deviations thus reducing overall drug development costs.
Subject Identification & Enrolment: EHR readily contains a large volume of data. If used correctly it can help to assess a subjects’ eligibility for clinical trials enrollment. This data is based on Demographic information, Past/Concomitant drug, and Comorbidity Interactions details. With predefined procedures and standards/customized programs, NGCP will help the sponsors in identifying, screening, and recruiting subjects based on age, gender, geography, and disease condition.
Trial Monitoring: On-site trial monitoring is an expensive process. Monitors have to visit all the sites to perform SDV (Source Data Verification) by comparing source materials with data entered into the trial database. This intriguing and time-consuming process might be eliminated by establishing the effective procedures around the use of EHR. eSource and EHR integration, enabled by NGCP, can result in timely access to personnel and longitudinal healthcare trial data for review. This can also facilitate post-trial follow-up to assess long-term safety and efficacy of an investigational product.
Other major benefits of the use of the EHR-enabled integrated platform are to have zero transcription errors due to elimination/reduction in the manual intervention of data (for example, data entry). This improves overall data quality, reduces paper-based documentation, and increases regulatory compliance. In addition, information on current and proposed trials can be made available to the stakeholders with full adherence to applicable confidentiality norms.
The following figure gives the information about the benefits for the stakeholders.
How can HCL help?
HCL’s strong technological background and deep domain knowledge help create a customized and tailor-made strategy for leveraging EHR data.
- Building a feasibility study, go-to-do strategy, and creating a roadmap
- Facilitating, developing, and using intelligence from EHR data, performing quality assessments
- Designing and developing sustainable strategies by mapping to the core capabilities of the sponsor
- Developing a governance mechanism and taking care of regulatory compliance
NGCP: EHR-CT Integration Platform as service
- Evaluating the data based on validity, reliability and integrity
- Removing duplicate data sourced from multiple EHR providers
- Creating a standard data structure based on the source document
- Data auditing, mapping based on the regulatory guidelines
- Automated electronic transmission of relevant EHR data to the EDC system
- Automated decision supports to enhance patient safety and study conduct efficiency (Predictive & Operational analysis)
- Support tools for data managers and investigators
- Identify potential subjects based on the source document
- Mapping clinical trial protocols to sites
- Collecting feedback information from sites
- RBM (Risk Based Monitoring) enabled
- Remote Sensors to monitor the subjects in trial (mHealth)
- Capturing real time Adverse Event / Serious Adverse Events (SAE) using EHR data (eSouce)