Studies have shown that a good part of clinical trial costs is dedicated to manually retyping EHR (Electronic Health Records) data into the clinical trial system leading to delays and errors. EHRs are the electronic version of a patient’s health records. They form a rich source of readily available health data about population health, disease prevalence, usage, side effects, and benefits of medical treatments or administrations.
Clinical Research Organizations, sponsors, and biopharma companies can work this data through integration with Electronic Data Capture (EDC) systems. An electronic data capture system is software that stores patient data collected for and during a clinical trial. An integrated EHR and EDC now present a technological leap that assures increased clinical trial efficiency.
EHRs are digitized paper medical records containing patients' clinical and medical history, including diagnoses, medications, test results, and other relevant information. They have enhanced patient care by enabling healthcare providers to access and share critical patient data in real-time, resulting in better-informed decisions and improved patient outcomes. And its most important contribution is the reduction of mammoth costs of EDC data entry.
There has been an increasing interest in health records for clinical research trials, and the former has the potential to revolutionize health research and patient outcomes. With active use of health records, medical interventions are evaluated, and aggregated information is recorded in the original systems. This procedure, in turn, facilitates improvements in clinical care, service delivery, and the health system.
A patient's health record contains a patient’s medical history, demographics, vital signs, diagnoses, medications, course of treatment, immunization record/ dates, allergies, image records (x-ray, ultrasound, radiology), and laboratory and other test results. Using health records for clinical research purposes means access to more data to complement a health survey, supplement wearable device data and missing data, and considerably reduce the burden of a participant.
Health records play a vital role as a deciding factor for the inclusion or exclusion of a prospective participant. Scrutinizing health records could serve as a preliminary for screening participants fit for the clinical trial. A diverse population, natives of a particular geographic area, people with a specific education grade or an annual household income; a clinical study/research could be about a health deficiency from amongst any of the abovementioned groups.
Sieving the health records of a particular group of people could help the researcher decide upon the course of treatment marking out the commonalities or dissimilarities among them. Health records are, therefore, a criterion for eligibility parameters. Health records are not only confined to being used for patient selection for engagement in a clinical trial but are also deployed for the trial also. These enable patient-centered outcomes and also provide high-quality, standardized data. The data thus derived improves population health and healthcare services and enhances and encourages continuous learning across all healthcare systems.
Screening potential clinical trial subjects for demographic or health eligibility is the linchpin of a successful enrollment procedure and a consequent streamlined clinical trial. The first round is the pre-screening, which happens before the patient consents to become the subject. This initial connect with the patient might happen over a phone call and involves a brief questionnaire about the subject and a general overview of the trial.
This preliminary screening determines if the subject is fit for a further round of screening. The preliminaries include questions about age, demographic details, prior treatments, comorbidities, pregnancy, and any known organ dysfunction. After getting clearance, the patient goes for additional screening that includes more detailed scrutiny of a patient’s medical past and current present health, which means a physical examination, relevant lab tests, or diagnostic tests (e.g., MRIs or x-rays, etc.). This round of pre-screening of a participant's health status ensures a smooth sail-through of the clinical trial.
The difference between the next level of screening and pre-screening has more to do with the observation of regulations. So pre-screening activities occur before the patient gives his consent. Completing this round qualifies the patient for additional screening, and the procedures in the latter can only happen with informed consent.
An additional screening procedure called Enrichment Design is built-in within clinical trials, which entails active treatments. These treatments help identify patients who show positive results after administering test agents during the trial's first phase, and this identifies patients who show a better therapeutic response. So, the additional screening procedure reduces the prospective target participants to a small selective group, making the selection process easier and more effective.
Additional screening or enrichment design in a trial is all about studying patient characteristics to select or disqualify a study participant group according to a drug effect shown by them. Three categories of enrichment strategies decide the inclusion or exclusion of prospective participants:
Strategies to decrease heterogeneity: For this inclusion and exclusion criteria, the placebo lead-in periods are used to exclude patients that improve naturally or patients taking pharmacologically similar drugs. Patients with comorbidities are eliminated as they would hinder the smooth completion of the treatment period. The removal of these patients helps establish homogeneity in the patient group.
These strategies include a patient group with a specific disease-related endpoint and involve clinical and laboratory measures and gene expression profiles. This strategy works for making a prognosis for the patient outcome but cannot predict the drug's efficacy.
Predictive enrichment strategies in clinical trials: This strategy aims to identify and enroll patients who are most likely to respond to a study drug. Ultimately this saves a lot of monetary and resource wastage and expedites bringing the therapeutic outcome to the market.
But the entire strategy can only be cost-effective if an EHR is integrated into the system. If the study trial has to rely on manual input of patient data, then the feared lacuna of every trial returns to delay the study and escalate the cost.
Automation for laboratory procedures is gaining a rapid foothold to alleviate heavy workloads and smoothen workflows, reducing monetary investments in human resources and tightening timelines. Automation has percolated all aspects of the clinical trial, but most noteworthy are the preanalytical (collection, receiving, storage), analytical testing, and post-analytical (archiving, reporting). Automation boosts efficiency and reliability and reduces labor. So collecting lab test results during a clinical study would ensure data integrity and zero loss of time.
Software-based EDC systems facilitate clinical studies to collect, store, and investigate data digitally. They are enhancing data security and accessibility at the same time. Since EDC systems are distributed in the SaaS (software as a service) model and can be accessed over the internet, it saves a lot of time and cuts down the cost of completing a clinical study. This system is designed and built to collect and organize data from a clinical trial study. It includes patient lab reports, test results, and readings from patient-attached medical devices (e.g., blood pressure, heart rate, oxygen saturation, blood glucose level, etc.).
EHR integration enables the automatic transfer of patient data from the EHR to the EDC system, eliminating the need for manual data entry and reducing errors. This integration allows for real-time data analysis, thus improving data quality and resulting in a more accurate and efficient clinical trial.
Health records are very valuable for clinical research. They might contain biospecimens, genomic data, and information on social determinants of health. They are also used to identify patients eligible for trial.
To ensure the success of a clinical trial, it is therefore crucial that the patient is supportive about sharing their health records with the research team. The patients give eConsent to being a part of a clinical trial. Two terms, ‘opt-in’ and ‘opt-out,’ are frequently used by a trial participant to signify the level of permission that has to be given to the healthcare organization. ‘Opt-in’ consent means that the trial organization has permission to access his health records for all future requests throughout the trial.
An ‘opt-out’ system entails the patient signing a new informed consent form every time the records need to be accessed by the researcher. There are, therefore, four types of eConsent that set limits to accessing the health records of a patient;
This is the ‘opt-in’ model where the patient gives complete and unconditional access to his health records to the healthcare professional. This consent is used throughout the trial unless it is revoked.
Patients who give this category of eConsent put in a few riders. All future requests will ensure that the exceptions included by the patient are respected. These exclusions might be:
a) Disclosure of a gynecological procedure,
b) Disclosure to family members,
c) Or, disclosure for purposes unrelated to treating a cardiovascular issue.
This type of eConsent denies access to entire health records except for specific conditions highlighted for consent. For example, the participant might allow different body fluids to be sent for testing to a diagnostic laboratory for a series of tests, the results of which are to be shared by the researcher for further medical administrations/treatments.
This eConsent is also known as an ‘opt-out.’ It means the patient has been denied access to his health records. And every time they are needed for study, the healthcare/trial researcher has to get the participant to sign a new eConsent. This type of eConsent decreases the ease of clinical access.
These eConsent forms are integrated with EHRs, and the patients/participants have only to sign the form permitting the research organization to access their health records. The integrated EHR makes the procedure simple, quick, and error-free.
The Cures Act is all about dealing with complicated Health information technology, Which means electronic health records and interoperability among health systems. The Cures Act seeks to streamline drug approval processes and prohibits information-blocking practices. This legislation “will give patients unprecedented access to and control over their medical records.”
It is also aimed at improving care coordination by giving patients the freedom to accrue and share their health records with clinicians and physicians to seek a second opinion. The information-blocking approach of healthcare providers and participants increased healthcare costs and reduced quality and safety measures. Therefore, the Cures Act is a call to action for healthcare organizations to give patient-centered care based on integrated healthcare information.
The patient can own and view their healthcare data, decide and control who views it, and ensure that all their health records are in one place to be accessed whenever they desire. Until recently, accessing health records could only be done through request forms, which would then get an authorized worker to give the patient a hard copy. But the U.S. Federal Rule, The Cures Act, puts the patient in charge of his health records which can be accessed at a click of a button by healthcare givers or CROs.
The Cures Act, A U.S. federal law, also provides for creating a Patient Portal, a secure online portal with a patient’s EHR posted on it, as soon as the health record is created. It can be used to access lab results, update patient profiles and allow patients to fix appointments with their practitioner or clinical trial organization, as the case may be. For the trial team it means increased patient engagement, participant loyalty, smooth management of costs, and streamlined workflows.
The Cures Act aims to advance health system interoperability and address data-blocking issues. The definition of interoperability under the Act means “all electronically accessible health information” to be accessed, exchanged and used without special effort on the part of the user.” The Care Quality Network connects health information networks across the entire United States of America. It is an interoperability framework that ensures healthcare data exchange seamlessly and successfully across the U.S. Its working is similar to cell phone networks. It brings vendors and service providers together to enable a smooth flow of data connecting networks, platforms, and geographies.
An integrated EDC and EHR within the ambit of care quality network would allow for easy and quick access to patient data. The two have become powerful tools for patient recruitment and enrollment, and every clinical research that leverages this health informatics tool can ensure the successful completion of a study. Data sharing is the path to promoting clinical research efficiency and increasing diagnostic and therapeutic developments.
EHR automates the transfer of patient information from sources, such as laboratory systems and imaging devices, into a centralized system, thereby eliminating the need for manual data entry and its consequent risk of errors. It gives real-time access to patient information that helps healthcare providers make informed decisions and enhance their patients' care routines. Moreover, EHR integration streamlines administrative and clerical processes like settling bills and insurance claims, improving revenue cycle management.
Implementing an EHR system and its integration with healthcare technologies requires investment. Still, it assures returns in terms of long-term benefits, reduction in data entry costs, enhanced patient care, and well-managed administrative machinery. An EHR integration into the central system of an organization does away with the problems and costs associated with manual EDC. It makes the entire process of a trial or treatment straightforward and simple, bringing down the costs in terms of time, money, and human resources.
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