An electronic data capture (EDC) system is a computerised system designed to collect clinical data in an electronic format for use mainly in human clinical studies. EDC replaces the traditional paper-based data collection procedure to streamline data collection and reduce the time it takes for medicines and medical devices to reach the market. EDC solutions are often used by pharmaceutical companies and contract research organisations (CRO).
EDC systems often provide:
- a data entry component with a graphical user interface, a data validation component that checks user input, and a deidentification element to make data less recognisable
- a reporting tool for analysing the data that has been collected
Life sciences organisations, which include the pharmaceutical, medical device, and biotechnology sectors, utilise EDC systems in all aspects of clinical research. However, they are particularly useful in late-phase (phase III-IV) investigations, pharmacovigilance, and post-market safety monitoring.
EDC can save data collection time and increase the accuracy of data utilised in drug and medical device studies. The trade-off that many pharmaceutical firms face when installing an EDC system to aid in drug development is a highly costly start-up period followed by significant benefits throughout the trial. As a result, in order for an EDC to be cost-effective, the savings throughout the length of the trial must surpass the setup costs. This is typically exacerbated by two factors: first, initial set-up expenses are more than expected due to the study’s original design in EDC, which is a consequence of poor planning or lack of expertise with EDC implementation. Second, the original design of the research in EDC does not permit cost reduction during the course of the investigation.
The overall consequence is an increase in the cost and risk of the research, with modest improvements. Many of the previous limits for study design and setup have been eased with the development of today’s EDC solutions, owing to technology that enables point-and-click and drag-and-drop design modules. Deploying EDC may now compete with paper methods in terms of study start-up time due to little to no programming needs, reusability via global libraries, and standardised forms like as CDISC’s CDASH. As a result, EDC technology is already being deployed in early stage research.
EDC is sometimes attributed to remote data entry (RDE) software, which first debuted in the life sciences industry in the late 1980s and early 1990s. Nonetheless, the Institute for Biological Research and Development (IBRD), a contract research company, might be the source. Drs. Nichol, Pickering, and Bollert established “a controlled system for post-marketing surveillance (PMS) of newly approved (NDA) pharmaceutical products,” with surveillance data “entered into an electronic data base on site” as early as 1980.
Doctors, nurses, and research study coordinators acquire clinical research data—patient data—during the investigation of a new drug or medical equipment in medical settings (offices, hospitals, universities) all over the world. Historically, this information was collected on paper forms and provided to the research sponsor (such as a pharmaceutical company) to be recorded into a database and then statistically analysed. However, there are some downsides to this procedure:
- Multiple copies of the same data result in errors.
- Errors occur but are not found for many weeks, delaying sponsors’ access to information on patients’ medical conditions.
RDE systems were designed so that physicians, nurses, and study coordinators could enter data immediately in the medical setting to tackle these and other problems. Transferring data from the sponsor site to the clinic or other institution may have many benefits, including:
- Data checks might be conducted in real-time as data is submitted, totally eliminating some errors and advocating immediate rectification of others.
- Sponsors may get data every night, making it simpler for them to keep track of the study project’s progress and the participants.
These early RDE systems collected patient data using “thick client” software that was locally installed on the hardware of a laptop computer. The gadget could then broadcast the data back to the sponsor on a regular basis and collect inquiries from the sponsor for medical specialists to react to through a modem connection via an analogue phone line.
RDE, although efficient, has a number of downsides. The most significant disadvantage was the need for equipment (such as a laptop computer) to be transported, installed, and maintained at each investigational (medical) site. It became pricey for sponsors, and it was difficult for medical workers. Due to space and usability concerns, medical practitioners were very dissatisfied. With the emergence of the internet in the mid-1990s, the adoption of web-based software that could be accessed using the existing computers at the investigational sites was the natural solution to some of these challenges. EDC represents this new kind of software.
The market has changed significantly since the late 1990s, when EDC started to emerge from RDE. Right today, the market is flooded with both new and veteran software providers. Many of these service providers provide personalised solutions to certain consumer profiles or phases of education. Modern aspects of EDC include cloud data storage, permissions based on roles, and designers for case report forms, in addition to analytics for clinical trials, interactive dashboards, and interaction with electronic medical records.
In contrast to EDC’s more traditional technique of collecting data on paper and then transcribing it into the EDC system, the FDA published its eSource recommendation in 2013. This advice provides strategies for gathering clinical trial data electronically from the start and storing it in the cloud. Despite the FDA’s webinar in July 2015 to further publicise the recommendations, eSource acceptance was initially slow. Initiatives such as the TransCelerate eSource Initiative (founded in 2016) were formed “to facilitate the understanding of the eSource landscape and the optimal use of electronic data sources in the industry to improve global clinical science and global clinical trial execution for stakeholders.” According to a 2017 study by the Tufts Centre for Drug Development Research, a “majority of [surveyed clinical information] companies” (up from 38% to 84%) planned to integrate eSource data over the following three years. According to 87 percent of research sites (2017), a transition away from EDC (or EDC playing a more complementary role) may be achievable since eSource would be “helpful” or “very helpful” if paired with today’s EDC.