New technological innovations and their increased availability have allowed for new opportunities to collect high-quality data minus the delays and errors. These technologies have eliminated the glitches and burden of paper-based data management for trial sponsors and their partners. For years, they had been under discussion and exploration. But now, e-source and EDC are transforming how things are shaped vis-à-vis the clinical trial industry. E-source records and stores data in electronic format from the beginning, and there is no intervention in the pen-and-paper collection of information. This, in turn, ensures increased efficiency, faster access, and as a result - quick and prompt decision.
According to a medical dictionary, e-source data, when put in the context of clinical trials, is “source data that is captured initially into a permanent electronic record used for the construction and evaluation of a clinical study.” The FDA (Food and Drug Administration) defines e-source as “any combination of text, graphics, data, audio, pictorial or other information represented in a digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.” The scientific conduct of clinical trials requires a thorough evaluation of newly developed products in pharmaceutical, biotechnology, and medical device companies. So, the clinical trials industry banks heavily on clinical research data from human subjects and medical records. This data can include information from original records and certified copies of original documents of clinical findings, observations, or other activities conducted during or before the trial. It is collected digitally without copying the data on a piece of paper first and then transcribing it to an electronic data capture (EDC) system.
Pharmaceutical companies have adopted several innovations to capture data when conducting a clinical trial. The most common and supposed to be convenient was the pen-and-paper. But this is very time and resource-consuming. Today, the EDC swept away the lacunae that the traditional manual methods had created. An electronic data capture (EDC) system - also called electronic case report form (eCRF)- is a software tool used to collect, sanitize and analyze the data generated in clinical studies. It is typically owned by the sponsor or a site conducting an investigator-initiated trial to collect, analyze and report.
Both e-source and EDC are popular technologies for collecting and managing data from a clinical trial. They have come about as a result of a change from an environment that was a combination of paper and electronic data picked at the time and point of generation. But both are very different from each other in the way they work. To understand the workings of these technologies, we need first to understand their scope and method of working. E-source documents initial data within a clinical study. For example, it may include data related to initial blood pressure, temperature, height, weight, and other essential parameters. Throughout the clinical trial, uniformity and integrity are strictly maintained by using an audit trail to identify any changes that might have occurred in the recordings. E-source, then, is the digitization of the entire process. Instead of recording source data manually and transferring it to an online database, e-source captures data directly onto CDMS(clinical data management system). A detailed electronic audit trail follows this. There is no scope for data transfer from a paper by manual means.
EDC is a software product employed by Life Sciences Organizations conducting research studies in a controlled environment. These have data forms that can be used for any study, workflow rules to facilitate data entry, logic checks for conducting quality checks of data, and reporting metrics for the rate of progress. These record specific data about the patients participating in the research studies. We find that both e-source and EDC capture patient data. So what is the difference? EDC is used when sites record data on paper source forms and then transfer the data into a database. E-source is used when the site records source data electronically without any paperwork intervention. This eliminates any risk of submission errors.
Electronic Consent is also known as electronic informed consent (eIC). The volunteer patient/subject gives informed consent to participating in the research study or clinical trial using electronic-based processes and systems. The information reaches the issue via computers, tablets, websites, or smartphones, i.e., any electronic device rather than paper. The digital format of the data for educating the subject uses a variety of media such as text, graphics, audio, video, podcasts, and passive and interactive sites. Enumerating the advantages and benefits of eConsent, it was evident that the latter won over a paper consent form. It keeps participants engaged while individual progress is tracked and recorded, and a comprehension check is carried out simultaneously. From the staff's perspective, detailed analytics and remote access have been made possible, and real-time alerts have improved consenting efficiency and data quality. And if eConsent is integrated with EDC, then data immediately becomes to the trial managers, who can map which participants have begun or completed the eConsent process. By consenting, the patient gives access to his medical and EHR (Electronic Health Records) as source data.
Interoperability in healthcare has become imperative for information exchange to happen smoothly. This can happen only with the help of technology integration. EHR plays a vital role in achieving healthcare interoperability. EHR is a system healthcare providers use to store and manage patients’ medical reports/records and generate data while the trial/research/treatment progresses. It is a system of keeping medical data within quick reach that helps medical practitioners access information and make quick decisions about the course of action. However, patient files are often stored in multiple systems in different formats. To achieve an enhanced workflow and data sharing, integration of EHR is an absolute must. The nurses and practitioners have to be able to access their patient’s medical records without any time lags, and for that to be possible, data has to be seamlessly integrated. Integration of the EHR system connects it to other application systems that the healthcare provider is using.
EHR integration also addresses communication issues with the patient/subject. They can not comprehend their medical condition. Patients can interact with their clinicians if this integration is patched into patient websites and applications.
Electronic Clinical Outcome Assessment is the digital face of clinical outcome assessment. This exercise assesses and calibrates a patient’s/subject’s response, functioning, or feeling to the treatment administered to him. It is used as a part of a clinical trial to measure the effectiveness of the medical intervention adopted by the practitioner. The software system is deployed through devices like computers, tablets, and smartphones to allow patients, caregivers, or practitioners to record the outcomes of clinical trials directly. This prevents any misrepresentation or loss of data while maintaining continuity. This system is used in conjunction with ePRO.
Electronic patient-reported outcomes facilitate patients to report on their health status and answer questions directly through a computer, tablet, or smartphone. Clinical trials today are patient-centric, and the outcomes are primarily based on patient responses. So, having an e-PRO system is having an e-COA for seamless healthcare interoperability. It also ensures quality data as the recording of responses is mainly real-time. Patients, too, are more comfortable answering questions than writing down their feelings. Both work together to help clinical trial patients communicate their symptoms and experience directly with the staff and sites. These systems are a significant technological breakthrough for the healthcare industry. E-PRO connects the practitioner and the patient to clearly understand the trial outcomes and the subsequent way forward. Here e-CRF or electronic case report forms are critical for effective clinical research. An e-CRF is a digital, web-based questionnaire to collect data from the patient/subject. A clinical research coordinator might manually enter the answers to the questions, or they might have been answered directly by the participant. The information from these forms is then analyzed and collated to conclude the route to action.
We are living in an age where everybody is connected, even senior citizens, who are known for their technophobia. Handheld devices and wearable devices which transmit the health parameters of the wearer/owner in real time to the physician/practitioner are freely available today. It is the healthcare industry. Therefore, health devices and remote patient monitoring (RPM) technologies are growing by leaps and bounds. RPM technologies are a close cousin of telemedicine technologies since they are the software-powered device that observes the patient and reports it back to the provider/practitioner - as the case might be. This facilitates patients with chronic illnesses to be in constant touch with their caregivers. Any emergency can thus be addressed safely without losing time, which can turn it into a casualty.
This has been particularly useful during the corona pandemic, where connected health and RPM became more critical than ever. It enabled physicians to monitor patients remotely without having to check their parameters physically, thus arresting the contagion effectively. This technology also helped to keep less severe patients out of the hospital and preserved bed space for cases that needed round-the-clock monitoring. Hospitals globally use connected health and RPM technologies to diagnose or dispense treatment.
Examples of patient monitoring devices include Fitbits, wearable heart monitors, Bluetooth-enabled scales, glucose monitors, skin patches, shoes, belts, and maternity care trackers. These non-invasive devices acquire, transmit, process and even store a patient’s health data allowing the clinician access whenever required.
These apps are purposefully built to connect the patient, carer, and family, giving all three parties the necessary tools for connected care. They can interact with each other within the circle of care that has been established. With a simple touch, the app enables the patient/subject to call, chat, or share images with relatives or carers. More comprehensive vital data is collected via the apps in the smart devices, which are immediately accessed and processed. Types of apps that are available include IoT apps, Questionnaire apps, and video conference apps.
Clinical trials are crucial to drug and clinical intervention development. A trial has multiple phases to ensure the ultimate product/outcome is safe for human consumption. Researchers designing a trial face several challenges. This includes recruitment and retention of participants, multi-layered compliances and regulations, data management, and lack of participant diversity, improving patient experience, patient data capture, access to non-traditional data sets, and remote patient monitoring. The answer to these roadblocks is the Decentralization of Clinical trials, which might be the future of architectural research design. A decentralized, patient-centric approach met with technological breakthroughs can address and mitigate the challenges of the new standard corona times.
