Information Technology hailed as tool to streamline trials
competitive, paper-based trials are not the way forward. Instead,
electronic data capture (EDC) and management technology solutions
are now readily available and becoming more broadly adopted.
The view comes from an eminent professor, who is considered a leader in the field of electronic data management systems for clinical research. He believes the new generation of EDC tools has advanced to such a degree that the reduction of research study costs, improved quality of data collected and speed of study completion are now entirely possible.
Speaking at the Pabord conference in London, Dr Khaled El Emam, Chief Scientist at TrialStat spoke of how exactly EDC could prove to be the most effective and how best to facilitate its adoption.
TrialStat has been tapping into the growing cost of conducting clinical research studies. In the current climate many small biotech firms and academic research groups do not have the budgets to put in place the large IT infrastructures required to support EDC.
Emam explained that a typical model would compose of a service provider that hosted the IT infrastructure. The client would access the functionality through their web browser.
In addition to reducing the capital investment by the research organisation, the latter does not have to possess any sophisticated IT knowledge nor capability in order to use a sophisticated IT solution. This means that the time required to move to EDC is reduced.
"We are now seeing that the interval between an organisation deciding to use an EDC service, and the time of actually starting the study, is often less than a week," he explained.
EDC has been applied to many different aspects of randomised control trials (RCTs) with a view to accelerate and streamline the complex process.
Emam said that EDC had already been applied to the design and startup of an RCT, in which it could be used to decide which sites to include in the study as well as deciding on the workflow.
"EDC can make entering data in an electronic data capture system more time efficient as well as monitoring all activities related to the validation of data, from edit checks at the point of data entry, in batch mode, and monitoring visits," he added.
Emam outlined security as a technical solution in which he expected would have an impact on some of the RCT activities and contribute to speeding them up.
He identified security as essential to the success of EDC, explaining that data would be digitally signed at the site before it is sent to the central database. In addition, audit trails are digitally signed and selected fields are encrypted at the site.
Emam said: "The advantage here is that any risk of any stakeholder (sponser, site) manipulating data is minimal. This is important for meeting the requirements of 21 CFR Part 11."
"Other advantages include highly sensitive data can still be hosted, but it is visible only to each of the sites. In addition, the security makes the case for direct data entry into an electronic system rather than onto paper first and then from paper to electronic."
He concluded by illustrating the potential of EDCs, pointing out that the evidence of its effectiveness was accumulating, ranging from cost reductions to improved recruitment.
"An integrated set of EDC technologies and features will facilitate global participation in trials since the infrastructure requirements at the sites are minimal and they can deal with complex data management requirements," he said.
