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October 2, 2020updated 21 Jun 2021 9:13am

How paper protocols may be harming your clinical trial’s success

By Sarah Williams

Convenient, timely access to clinical trial protocols has long been a problem in the pharmaceutical industry as these critical study documents are still largely distributed as paper documents. It’s not surprising then, that protocol violations and deviations are among the most common issues with trial performance and among the top FDA observations each year. Yet despite this problem in clinical trial management, it has yet to be addressed wholesale in the industry.

Not having instant access to the protocol at the point of care can lead to mistakes when doctors and study coordinators rely on memory or follow the wrong version of the protocol if there are amendments. But it’s not easy as they need to physically go to the protocol, which is most likely stored on a desktop computer or paper binder – often not at all where participants are treated.

Mistakes slow down drug development, leave vulnerable patients without access to potentially life-saving treatments, and can jeopardize patient safety. Simply put: the old way of managing clinical trial instruction via paper or desktop computers doesn’t support the execution of trials – it makes them slower, less efficient and overall, from a regulatory point of view, less compliant and successful.

No more paper protocols

And, while incredible advancements have been made with modern medicine, more can be done. A lot more. So, what is needed to make clinical research more simple, transparent and accessible? The answer, suggests Irish software firm Teckro, is to move to digital engagement.

“We manage the rest of our lives through our digital devices,” comments Brendan Buckley, Teckro’s chief medical officer. “Information is always easily at our fingertips and it makes life better. So why do we still rely on paper protocols for clinical trials?”

And Buckley makes an excellent point: in the cutting edge of modern medicine, why has access to the main trial interface– the protocol – not kept pace with modern technology? There certainly is no regulatory barrier, meaning the problem may simply be an age-old one of, “We’ve always done it this way.”

The challenges the industry faces do indeed seem to be compounded by reliance on paper protocols.

“By issuing sites with paper protocols or PDFs hosted in a web portal somewhere,” Buckley expounds, “we’re indirectly asking our clinical investigators to do the impossible. We’re asking them to freeze time during patient consultations to manually search through dozens of pages to query eligibility criteria, remember investigational product calculations and/or titrations, or check for appropriate management of adverse events. Either that, or to memorise the exact correct version of the entire protocol. Bear in mind that many investigators and site staff work simultaneously on multiple trials.”

In a world where it’s not uncommon for investigators to manage multiple studies simultaneously and see between 20 and 30 patients a day, the existing process simply creates the conditions for a perfect storm.

So what can be done?

By digitising the protocol and other study documents (by using software and a digital engagement platform such as those Teckro provides) vital information is instantly available 24/7 to all authorised study stakeholders simultaneously – anytime, anyplace. Teckro provides clients with the ability to rapidly and intelligently give instant and accurate answers to those who need it and to provide suggested next best actions.

“Think of it as a virtual coach on your shoulder that can help guide decisions and actions at each stage of the trial,” says Buckley. “What’s more, it’ll always be the current and approved version for each site. Teckro is compliant, audit-ready, and provides actionable intelligence on usage and adoption to study teams so they can maximise their investment.”

It’s easy to use and available on any digital device. Research staff simply type in a question into Teckro’s dedicated search engine and the right answer is returned in seconds. Monitors and sponsors gain the added benefit from analysing search trends to see which sites are engaged with the protocol and also to catch potential issues early on.

Number crunch

And the numbers speak for themselves: the technology is currently used by more than 16,700 research sites globally across six continents. Sites using Teckro recruit more patients and have fewer deviations compared to those sites not on Teckro.

“The benefits are so outstanding that it’s almost a no-brainer,” Buckley concludes. “By transforming the protocol into actionable data for everyone, the right patients are recruited faster, protocol adherence improves, and safety issues are rapidly and effectively managed.”

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