The data gathered during a clinical trial is unquestionably every trial's purpose and also its legacy. Weeks, months, or even years after patients finish the study, equipment is boxed up, and clinical trial groups move on to new challenges and investigations, the data remains— playing a central role in future research.
Electronic data capture (EDC) systems have been around for decades and evolve and improve as new technologies advance. Now, sophisticated EDC systems can accommodate and facilitate activities to maximize data integrity and quality. Octalsoft's EDC integrates best-in-class usability and flexibility with strong security mechanisms and necessary data analysis features.
The Data Integrity Landscape for Clinical Trials
Clinical trials continue to face several challenges, including issues related to data collection and analysis.
Today, clinical trial teams are dealing with more data, collected from disparate sources using a variety of means. This brings a multitude of challenges in terms of how they manage and analyze this data.
Availability of additional data presents possibilities, like the possibility to gain a solid image of the safety of a drug in early-stage clinical trials and to predict more accurately about dosing in phase II and beyond trials. More data, however, also produces more challenges. As data grows, so does the requirement to deal with it, avoid mistakes, and process that data more efficiently to obtain useful information.
Embracing the issues posed by data overload, the United States Food and Drug Administration (FDA) put out draft guidance in 2023. Such guidance targets upholding data integrity in clinical trials.
Amongst other suggestions, the FDA offers the increased implementation of decentralized clinical trials, alongside the utilization of digital health technologies (DHTs) such as wearable sensors. DHTs provide potential for the capture of patient-reported data directly.
Yet another approach to facing the challenges posed by multitudes of clinical trial data is employing an EDC to automate the collection of data. An EDC system can assist clinical trial teams to minimize errors while keeping real-time tabs on how trials are advancing. A sophisticated EDC even has the capacity to collect decentralized data directly, minimizing the risk of errors or omissions occurring through manual input.
How EDC Systems Keep Data Integrity
Because EDCs provide an adaptable method for data capture and management, clinical trial teams can access patient data points specific to the immediate trial and phase.
Although every clinical trial will have unique data capture requirements, most clinical trials need — and EDCs enable — capturing information such as:
- Demographic data regarding study participants.
- Medical histories for all study participants, including previous conditions and treatments, allergies, current medications, surgical histories, and so on.
- Clinical assessment data, such as laboratory results, vital signs, and physical examination notes.
- Patient-reported outcomes (PROs), such as both qualitative and quantitative data.
Leading EDCs achieve a critical equilibrium between data security and data integrity. Such EDCs streamline data capture and analysis for the clinical trial team while making use of features like role-based access and audit tracking to make sure that data is securely stored and even the smallest changes can always be traced back to the source.
EDCs are also very important in the collection of clinical trial data and storing it in one secure place. When utilized properly, EDCs can also assist clinical trial teams in streamlining processes, enhancing clinical trial speeds, and decreasing costs.
Features to Look for in an Advanced EDC System
EDC systems have been around for decades, and they've evolved just like other computing has evolved over the past decades. The latest EDC systems available today include:
- Simple, intuitive formats. A sophisticated EDC is straightforward to use, with layouts and access to data in a format that is easy to comprehend. Seek an EDC with embedded tools to walk users through data entry, minimizing omissions and errors, and simple-to-use tools to filter and organize information. Guided prompts also ensure data is complete and accurate.
- Convenient access with strong security. The best EDCs today are available from any internet-enabled device, making it possible for clinical trial teams to work on a desktop, laptop, or mobile device whenever they need. Convenient access is offset with strong security measures, like role-based access, that keep data secure.
- Simple study-building tools. Clinical trial teams in a state-of-the-art EDC can construct simple or complicated studies tailored to their requirements for phase I through IV trials. Easy reuse of forms and tools and automated edit checks make the study build process faster.
- Integrated ePRO. Electronically collected data on patient-reported outcomes (ePRO) ensures that data from patients is kept in its original state, not lost or accidentally altered through manual entry.
Octalsoft's EDC is a high-end, user-friendly system that provides greater usability and flexibility. Customers are able to streamline the collection, processing, and submission of clinical trial data, accelerating the development and approval of new treatments and therapies. Want to know more about how Octalsoft’s EDC can enhance your clinical trial’s data integrity while expediting findings?
