Empty desk in a lab; data integrity concept

Data Integrity in Clinical Trials: The Role of Advanced EDC Systems

The data collected during a clinical trial is the trial’s goal and its legacy. Long after patients have completed the study, equipment is packed up, and clinical trial teams move on to new challenges and investigations, the data lives on — playing an essential role in future research. 

Electronic data capture (EDC) tools have existed for decades, and they continue to develop and refine as new technologies emerge. Today, advanced EDC systems can support and enhance efforts to optimize data integrity and quality. Anju’s TrialMaster combines superior usability and flexibility with robust security tools and essential data analysis capabilities. 

The Data Integrity Landscape for Clinical Trials

Clinical trials continue to face several challenges, including issues related to data collection and analysis. 

“Increasingly we are dealing with more data, collected from disparate sources using a variety of means. This brings a multitude of challenges in terms of how we manage and analyse this data,” says Iris Loew-Friedrich, Chief Medical Officer at UCB. 

Access to more data opens up opportunities, such as the opportunity to develop a clear picture of a drug’s safety in early phase clinical trials and to make better predictions about dosing for phase II and later trials. Yet more data also creates more challenges. As data expands, so does the need to manage it, prevent errors, and analyze that data more effectively to glean usable insights. 

Recognizing the challenges posed by data proliferation, the U.S. Food and Drug Administration (FDA) released draft guidance in 2023. This guidance focuses on maintaining data integrity in clinical trials. 

Among other recommendations, the FDA proposes the expanded use of decentralized clinical trials, as well as the use of digital health technologies (DHTs) like wearable sensors. DHTs offer the opportunity to gather patient-reported information directly. 

Another way to address the challenges posed by multitudes of clinical trial data is to use an EDC to streamline data collection, says Loew-Friedrich. EDCs can help clinical trial teams reduce errors and maintain real-time tracking of trial progress. An advanced EDC can even collect decentralized data or DHT information directly, further reducing the risk of errors or omissions from manual data entry.

Medical team in conference; data integrity concept 

How EDC Systems Maintain Data Integrity

Because EDCs offer a customizable approach to data collection and management, within an EDC clinical trial teams can capture patient data points relevant to the current trial and phase. 

While each clinical trial will have specific data collection needs, most clinical trials require — and EDCs support — the collection of information including:

  • Basic demographic information about study participants.
  • Medical histories for each study participant, including past conditions and treatments, allergies, current medications, surgical histories, and more.
  • Clinical assessment data, including lab results, vital signs, and notes from physical examinations.
  • Patient-reported outcomes (PROs), including both qualitative and quantitative information. 

Top EDCs maintain an essential “balance between data security and data integrity,” writes Saad Abbas of the University of Cambridge. These EDCs simplify the capture and analysis of data for clinical trial teams and also use tools such as role-based access and audit tracking to ensure that data is maintained and that changes can always be tracked back to their source. 

EDCs play a crucial role in collecting clinical trial data and maintaining it in a single secure location. When used effectively, EDCs can also help clinical trial teams streamline other aspects of their work, writes Jocelyn Reynolds in an article in Clinical Leader. For instance, clinical trial teams can identify ways to use their EDC to streamline clinical trial speeds and reduce costs.

Two scientists working together in lab; data integrity concept 

Features to Look for in an Advanced EDC System

EDC systems have existed for decades, and they’ve advanced just as other forms of computing have advanced during that time. Today’s most advanced EDC systems offer:

  • Intuitive, user-friendly formats. An advanced EDC is easy to navigate, offering layouts and data access that make sense. Look for an EDC with built-in tools for guiding users through data entry, reducing omissions and errors, as well as intuitive tools for filtering and organizing information. Guided prompts also help ensure data is accurate and complete.
  • Easy access balanced with robust security. Today’s top EDCs are accessible from any device with an internet connection, allowing clinical trial teams to work on a desktop, laptop, or mobile device as needed. This ease of access is balanced with robust security features, such as role-based access, that help ensure data stays protected. 
  • Straightforward study build tools. In a cutting-edge EDC, clinical trial teams can build simple or complex studies adapted to their needs for phase I through IV trials. Automated edit checks and easy re-use of forms and tools speed the study build process. 
  • Built-in ePRO. Electronically captured information on patient-reported outcomes (ePRO) helps ensure that data from patients is maintained in its original form, rather than lost or inadvertently changed through manual data entry. 

Anju’s TrialMaster is an advanced, intuitive EDC suite that offers superior usability and flexibility. Users can streamline the collection, processing and submission of clinical trial data, expediting the development and approval of new treatments and therapies. 

Images used under license by Shutterstock.com.

 Authored by Laura Acosta, VP of Product Management, eClinical Division

Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.

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