EDC vs. Paper
EDC vs. Paper Clinical Trials
Many organizations are faced with the challenges of transitioning their clinical trial programs to Electronic Data Capture (EDC). There is a certain amount of fear and uncertainty associated with this step as it represents a different way of doing business. It also represents the struggle between the devil you know (paper trials) and the devil you don't know (EDC trials). War stories of the early EDC technologies still linger even though the technologies and processes have improved significantly in recent years.
The main benefits of EDC over paper include reduced TIME, improved QUALITY and decreased COST. These benefits are illustrated at different points throughout the study lifecycle. The challenges of traditional paper trials lie in the management of resource intensive processes that are designed to ensure data quality but offer no transparency or flexibility in accessing “real-time” data, reports, or metrics. EDC, however, offers those benefits and more.
The Challenges of Paper Trials
TIME
Traditional paper studies require a significant amount of time dedicated to managing paper documents. This includes actual case report forms as well as managing the associated query processes, which require serial distribution of queries and their resolutions. The document management challenges require tracking of originals and copies at various site locations as well as in the sponsor's trial master file. Time lags are also associated with CRA source document verification that require multiple site visits over time.
QUALITY
Paper trials are cumbersome from a data perspective. Data entry errors are identified and corrected late in the lifecycle. This impacts the availability of clean data for review or interim analysis. Handwritten notes or comments often result in transcription errors that are carried throughout the study. Inconsistencies such as these can result in significant delays in data validation.
COST
The cost of paper trials includes management of the paper lifecycle as well as the resources to support it. Photocopying, tracking, indexing and storage are costly and require resources to conduct these activities. Double data entry, the method to ensure that data from paper CRFs are correctly entered into the database, requires time and money. CRAs can become rate-limiting steps (costing time and money) because CRF forms are not sent into the sponsor or CRO until the CRA performs a monitoring visit.
The Benefits of EDC Trials
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Edit checks at the point of data entry reduce the number of queries and the amount of time spent resolving them. This also means that clean data is available more quickly for trend reporting, analysis and risk assessment. Coding of adverse events can also be done as soon as data is entered instead of waiting until the forms are received and have gone through the processing step.. Clean data leads in faster database lock, which is a key milestone for most trials.
QUALITY
Data validation early in the process reduces likelihood of errors being carried forward in the data management process. Since all data is captured electronically, no transcription errors occur due to interpretation of handwriting or inaccurately keyed data. Quality data early in the process also enables adaptive clinical trials and enable early decisions making.
COST
EDC trials alleviate the need for double data entry as well as the need to send paper around the world to support query resolution processes. CRAs can minimize the amount of time spent on site for monitoring visits because they have tools within the EDC system to prepare for their visits. Query reports and tracking reports within EDC are available prior to the visit, providing visibility into potential issues. Monitoring visits may not be less frequent, however, time on site will be shorter and can be devoted to more clinical issues, such as Drug Accountability.
EDC also links to other systems and may provide additional advantages based on integrations that are not possible in a paper trial. Benefits may also be expanded by implementing EDC across entire clinical programs where efficiencies are leveraged across similarly designed clinical studies.
It is also important to realize that much of the output of an EDC system is destined for a regulatory submission. The US FDA accepts electronic submissions and has recommended that electronic data be submitted in CDISC SDTM format. Using an EDC system that collects data electronically and provides SDTM friendly output can save significant time and money by alleviating the need for costly and time consuming data conversions.
The EDC market is mature, technologies have evolved, industry's understanding of global clinical trials has expanded and processes have improved. This evolution enables organizations to rapidly realize the many benefits that EDC provides throughout the clinical data lifecycle.
