Clinical trials play a key role in the pharmaceutical, biotechnology and medical device industry. With a large number of drugs coming off patent, companies are under pressure to develop and test new drugs as swiftly and efficiently as possible. This requires an increase in clinical trials and a reduction in the time cycle of those trials.
Electronic Data Capture or EDC is the gathering of data collected by humans into computer systems without the need for manual data re-entry. EDC systems can speed time-to-market, reduce data entry errors, provide for early analysis and trend monitoring.
Data entry can be achieved using a number of mechanisms. Users can enter data directly into an electronic device such as a laptop PC, handheld device, tablet PC, and touch screen or tone dialing system such as IVRS.
EDC has been around for more than 10 years and still only about a third of all studies use it – the rest using paper-based data collection process.
While EDC has many advantages, a barrier to success is the expectation that the system is ready at the time of the enrollment of the first subject (patient). In order to achieve this target, one must have agreement on the data to be collected during the trial. I have found that this requirement frequently changes between the finalization of the protocol and first subject in. When paper case report forms are used, these changes to data can be more easily accommodated.
For EDC to become increasingly used in the pharmaceutical industry, they need to address the challenges prior to implementation. However, while pilot studies have been successful, pharmaceutical companies have not yet implemented EDC across the majority of their clinical trials. They are constrained by a lack of strategic planning, the varying requirements of each trial, the relative immaturity and fragmentation of the EDC software market and the need to address both process and change management.
- What data are you gathering?
- Is the site and clinical personal fully trained? What hardware do they have available?
- Validation – Is validation of input data required?
- Workflow – Do the data need validating, reviewing, approving and releasing for general consumption locally and centrally?
- Integration – Does the system need integrating with other computer systems? Regulations. Does the system have to conform to any externally imposed regulations, such as 21 CFR Part 11, Good Manufacturing Practice, or Good Laboratory Practice?
EDC eliminate the transcription error (paper-based errors) and therefore transcription errors.
- Double-Data Entry – The manual re-entry of data recorded on paper is expensive and unreliable
- Validation – Immediate validation of data entry
- User Friendly Web Forms – Data entry is quick and efficient
- Access to real time data – quick executive level decision and information
EDC helps reduce invalid data entries and speed up the availability of drug trial information.
While the EDC technology still faces some challenges, benefits will drive acceptance. A leading stimulation to growth will be the reduction in price and increased sophistication and power of small handheld devices. These developments are only useful if accepted by the users. Not all EDC systems are created equally, and one must carefully pick a system that best meets your need.
If a company changes from paper-based system to EDC system, this ‘innovation’ will have a human side. Successful implementation is not just a matter of installing the software and announcing the change. Stakeholders, who are responsible for collecting, processing and communicating clinical trial data must adopt and adapt to the new systems – ensuring that a technical innovation is actually successfully adopted.
With current standards CDISC initiatives, it is inevitable that the FDA will eventually demand all information be provided in this format — although no date has yet been set.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.
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