The Covid-19 pandemic has made it amply evident that technology needs to straddle and integrate two different spheres in the medical environment for clinical trials. This can only be done if the pharmaceutical industry and the healthcare providers join hands to bridge the gap in clinical care and clinical trial processes. The overall effect of EHR to EDC integration on trial processes, data quality, trial personnel resources, and time and effort can be huge. But the resultant integrated solution would undeniably improve the quality of healthcare data management and research for a clinical trial, marking it as a potential unicorn in the industry.
An integrated solution combining EHR and EDC provides functionality that helps researchers and healthcare providers access unstilted patient data from real-time medical records and clinical trial information. This integrated technical solution eliminates the need for multiple data entries and smoothens the way for data sharing across various healthcare platforms, thus enhancing efficiency and reducing errors.
This potential unicorn of a solution streamlines clinical trial processes, accelerates research timelines, and consequently cuts costs. Efficient patient recruitment, accurate data collection, and monitoring of a trial then contribute to expeditious drug development and improved patient outcomes.
The use of integrated EHR and EDC technical solution fosters interoperability and collaboration between healthcare organizations, researchers, and regulatory bodies. The on-demand seamless exchange of standardized data enhances data integrity, prompt, quick, and comprehensive analytics, leading to evidence-based decision-making and advancements in personalized medicine.
With this integrated solution, a trial or a treatment can be managed and completed smoothly and seamlessly, keeping costs within budgets. So we can safely look towards this technological breakthrough to optimize healthcare delivery, accelerate research and facilitate collaboration that would change the healthcare and clinical research data management approach.
An electronic health record (EHR) is a digitalized health statement of a patient. It is a real-time chart that instantly produces a complete record of a patient’s medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory test results for the personnel authorized to use such information. When this data is stored in a system, it is digitized and can be shared with healthcare providers across organizations to formulate a treatment or healthcare plan for the patient/volunteer participating in a clinical trial. This results in more coordinated and efficient care for the patient by providing accurate, up-to-date, and complete information about the patient at the point of care. Healthcare costs are considerably lowered by this technological advancement over the pen-and-paper forms filled by a clinician interviewing the patient. The use of EHR can also be extended to clinical trials; to assess their feasibility, to determine patient recruitment, and to streamline data flow.
Treatment options and vaccines for Covid-19 have been found as an outcome of aggressive clinical trials and research. The speed at which the data was harvested, collected, and analyzed was unprecedented. There was a rapid deployment of eSource to collect patient data from EHR. This method of picking data directly from EHR and integrating it into eSource bears the most significant impact on drug development and reduction of turnaround time for determining treatments particularly pertinent for remote patient treatment and decentralized clinical trials. Using technology to integrate EHRs and data collection into eSource can completely change how clinical trials and research are conducted. Using various types of machine learning, artificial intelligence and natural language processing tools, EHR data can be read and mapped into eSource. This facility of pulling data from an EHR and populating eCRFs results in a more expeditious model for a clinical trial. eCRFs are a part of EDC systems.
It is software used to collect data generated during a clinical trial or research. This can be captured at its source (eSource) or on paper. The latter is then transcribed into the EDC system. The trial sites, sponsors, or CROs (contract research organizations) are primarily motivated to use EDC systems because they provide cleaner data, faster access to data, and efficient, productive data. With the clinical research industry becoming increasingly technologically inclined, it has various technological platforms interconnected to streamline studies and analysis. For example, the research staff uses eCRFs completed via EDC systems (eCRFs are patient data forms inside EDC), and the eCRF has patient information collected by the clinical researcher. The clinician uses EHR to understand the patient’s health background and administer it to him accordingly. All the patient’s progress; reactions, both positive and negative are subsequently recorded by the EDC. Data, when accessed and recorded in real-time, is done through eSource.
It is a well-recognized fact that one of the most critical and resource-hungry tasks in clinical trials is data entry. EHR is an instrumental source of information for recruiting patients, and EDC is likewise for mapping outcomes of clinical trials. A resource spending hours on just keying in data could considerably run up costs of the trial and could also be doubtful about the authenticity of the data. Benefits of integrating EDC with EHR also include the reduction of unnecessary duplication of documents and errors by creating a single point capture of source data. This is only possible when an Electronic Health Record is integrated with Electronic Data Capture using software to transfer data from one to the other automatically. In a study, the data is entered into a medical record and then transcribed to an EDC system. To do this, either reams of paper forms would have to be referred to, or two computers would be set up side by side, or a data operator would have two windows opened on one screen. Many clinical sites even have an intermediate worksheet to copy EHR data which is then copied to the EDC system. This results in multiple transcription copies, data inconsistencies, and hiked costs. A combined, aggregated tool made with the integration of EHR2EDC would be a powerful facilitator for biopharma companies and clinical research organizations. The resultant efficiency can bring about a faster setup of clinical studies as it improves data provenance and reduces the need for data queries, data cleaning, and verification of source data.
It would also mean faster reporting of adverse events because of real-time access to data for review. This interoperability would contribute to a patient-centric strategy, help recruit and retain patients, and reduce pressure on clinical sites.
Data acquisition and analysis demands a resilient method that would mitigate the risk of disruptions, delays, and inconsistencies. It is thus proven that the best way to sidestep these glitches is to streamline data directly from Electronic health records to EDC forms. This direct data sourcing from EHRs can only happen with fully integrated clinical trial software solutions. In short, only through Interoperability.
Interoperability of softwares and platforms allows data to be inbounded and streamlined or obtained in a sequence through built-in export and import features. The operating software is such that its integrated functions facilitate a smooth and secure data transfer from EHR to EDC. Software designed to be semantically interoperable can also be tweaked to read and interpret data signals from different healthcare systems as soon as it is typed into the EHR.
Fast Health Interoperability Resource is a standard defining the parameters for the exchange of healthcare information between disparate organizations and their computer systems across all softwares and platforms. It allows the creation of apps that transcend document-based health information environments by being plugged into the EHR operating system and feeding the required information directly into the provider workflow. With this, the inherent pitfalls of the document exchange system are avoided, and the providers do not have to access data separately.
Using the export/import function, the EHR data is exported through FHIR, which includes data models, serialization formats in XML and JSON, and a REST-based API for quarrying clinical data. The clinical trial management system can then get the exported data into its own system. The FHIR, because of its compatibility with Substitutable Medical Applications and Reusable Technologies (SMART), provides for easy data flow from EHR wearables and various other platforms. It is based on technology such as wearable devices, the Internet of things, and mobile Internet to dynamically reach and access information and connect people, organizations, and institutions that are related to healthcare.
This is a workflow used by an application to request access to data, receive and then use it. The SMART-on-FHIR apps are three features of data transportation across software and platforms. It involves-
SMART is based on the OpenID Connect identity management protocol, which allows applications for access to clinical data. The request might be for read-only for a few records, read/write for the entire EHR, or it could be customized according to the requirement of the organization requesting data.
It accesses data using SMART-on-FHIR architecture. This has a set of services that use the Access and identity management layer to get to the data in the EHR.
With this, web-based applications with a set of contexts can be launched. The context can include selected patients, clinical involvement, and styling information.
The technology can be used to create applications that need a backend layer to support them. It is equally useful for creating mobile/mhealth applications that are interactive and user-facing. At the same time, this specification can provide ways for accessing data by being used in creating backend processing applications.
The Covid-19 pandemic has thrust trial management towards virtualization on the part of the patient and the sponsors. Demographic and geographical boundaries and time zones have to be straddled to maintain the continuity of trials and preserve data integrity. To address all of the above, technological advancements where EHR is mapped into EDC must be used. The limitations of traditional randomized controlled trials encourage the use of records ensuring speedy analysis and outcomes that could revolutionize healthcare evaluations and interventions. Technology has helped decentralization in fast-tracking processes which were long-winded and costly. Mobile technology and the increasing presence of smartphones, too, have aided hugely in real-time access to data remotely. It has also encouraged patients and volunteers to participate proactively in a clinical trial. With EHR2EDC, information is all set to break the limits of exclusivity and become accessible at the click of a button.
Managing mountains of clinical data is a challenging task. The pharmaceutical industry has shown an inclination towards cutting the flab and using recorded and stored data in double quick time. The importance of EHR to EDC has received recognition, and technological movements in this direction have been successful. Interoperable digital identity authorizations, authentication of electronic health records, validated digital signatures et al., have been used to access data provided by organizations and retrieved through internet-based links. By combining technologies, trial management systems too are becoming streamlined, allowing for a quicker supply of medical outcomes and treatments in the open market by integrating healthcare and clinical research settings. No longer is the integration of EHR and EDC a distant and disrupted trial or a unicorn.
Having recounted the benefits of using an integrated EHR and EDC technological functionality, it only needs to be repeated that this solution could be a potential unicorn. It has the ability to help both the healthcare and clinical research industry without the need for exclusive customization. The use of an integrated technical solution erases the negatives of legacy processes and showcases the positives that are entirely beneficial for the patient as well as the researcher.
