Electronic Data Capture (EDC)
Picture a clinical trial where every data point is meticulously recorded and validated in real-time, with the power of Electronic Data Capture (EDC) solutions at your fingertips. But, as with any advanced technology, the complexity and cost of implementation can be a barrier for some organizations.
On the other hand, imagine a paper-based clinical trial where inconsistencies and errors in data run rampant, causing headaches for data managers who must sift through mountains of pages to resolve them. But what if there was a solution that could make this process not only manageable, but a breeze? Enter EDC systems, which provide a sophisticated and streamlined approach to managing discrepancies and improving the overall process of data cleaning, even for large and complex studies.
An electronic data capture (EDC) system is like a digital wizard for clinical trials, magically transforming the tedious task of data collection into an efficient process. EDC systems allow for the collection of clinical data in electronic format, eliminating the need for paper-based data collection and speeding up the time it takes for drugs and medical devices to hit the market. These systems are widely used by pharmaceutical companies and contract research organizations (CROs) to streamline data collection and analysis.
Think of an EDC system as a one-stop-shop for data collection. It includes a user-friendly interface for data entry, a validation component to ensure accuracy, and a reporting tool for analyzing the collected data. These systems are especially useful for late-phase studies and post-market safety surveillance in the life sciences industry.
While EDC systems can increase data accuracy and decrease data collection time, they do come with a cost. The initial set-up process can be complex and financially demanding, making it challenging for some organizations to adopt EDC. However, with the advancements in technology, EDC solutions have become more user-friendly and require little to no programming. This makes the deployment of EDC more accessible and less expensive, even for early phase studies.
The birth of EDC can be traced back to the late 80s and early 90s, with the emergence of remote data entry (RDE) software in the life sciences market. But its origins might go as far back as 1980, with a contract research organization known as Institute for Biological Research and Development (IBRD), who offered “a controlled system for post-marketing surveillance (PMS) of newly approved (NDA) pharmaceutical products,” with surveillance data being “entered into an electronic data base on site.”
Traditionally, clinical research data, collected by physicians, nurses and research study coordinators, were recorded on paper forms and sent to the research sponsor for data entry and analysis. But this method had its flaws- data were copied multiple times, producing errors, and errors were not caught until weeks later, leading to delayed visibility into the medical status of patients by sponsors.
To fix these issues, RDE systems were created, allowing medical staff to enter data directly at the medical setting. This led to real-time data checks, preventing errors, and providing sponsors with nightly data transmissions, improving their ability to monitor the progress and status of the research study and its patients. However, RDE systems had their own shortcomings, such as the need for expensive hardware and support at every investigational site, leading to dissatisfaction among medical practitioners.
With the rise of the internet in the mid-1990s, web-based software was adopted, leading to the evolution of EDC. This new class of software could be accessed using existing computers at investigational sites, eliminating the need for expensive hardware and support, and providing a more user-friendly experience for medical staff.
The EDC landscape has undergone a metamorphosis since its inception as RDE in the late 1990s. Today, the market is a melting pot of new and established software providers, each offering specialized solutions catering to specific customer demographics and study phases. The cutting-edge features of EDC now include cloud data storage, role-based permissions, and case report form designers. The new era of EDC also includes clinical trials analytics, interactive dashboards, and seamless integration with electronic medical records.
The world of EDC has undergone a transformation since the advent of RDE in the late 90s. Today, the market is teeming with a diverse range of new and established software providers, each offering specialized solutions tailored to specific customer profiles or study phases. Modern EDC now boasts cutting-edge features such as cloud data storage, role-based permissions, and case report form designers, as well as analytics tools, interactive dashboards, and electronic medical record integration.
In 2013, the FDA introduced its eSource guidance, which advocates for the electronic capture of clinical trial data from the get-go and moving it to the cloud, instead of EDC’s traditional method of collecting data on paper and transcribing it into the system. Adoption of eSource was slow at first, but initiatives like the TransCelerate eSource Initiative in 2016 aimed to improve understanding and use of electronic data sources in the industry. A 2017 study by the Tufts Center for the Study of Drug Development revealed that 84% of surveyed clinical information companies planned to incorporate eSource data within the next three years, and 87% of research sites stated that eSource would be helpful or very helpful if integrated with today’s EDC. This shift away from EDC may be possible in the future.
