Clinical trials not yet paperless
Typically, when a major shift occurs in how things are managed, there is an adjustment period during which users embrace the new change but are reluctant to let go of some long-standing parts of the old way.
For example, take online banking. When banking first migrated online, many customers embraced paying their bills online, yet found themselves clinging to the manual process of writing everything into their checkbook registers. Today, we are seeing a similar adjustment regarding clinical trials.
Portals are transforming clinical trials just as online bill paying did for banking. It’s a new mindset—and with major shifts in the process, there is a natural tendency to dip one toe in the new process and keep the others in the security of “how it’s always been done.” A study team might consider its study to be progressive because it is utilizing an online portal for parts of the clinical trial management. However, this same team still might be uploading paper source documents and collecting wet signatures without understanding it has not realized the full capabilities of a true electronic/paperless system.
In order to go truly paperless with clinical trials, we must first realize printing, scanning and uploading paper files into a system do NOT make it paperless. With electronic distribution and collection of documents, the routing of paper can be a thing of the past. Although some systems such as electronic data capture (EDC) systems, electronic patient reported outcomes (ePRO) and interactive voice response systems (IVRS) already have been successfully digitized, many others have yet to advance.
Several areas are in the process of transitioning to paperless, meaning one or two companies offer the service One of these transition areas is study start-up, which traditionally has been a long, paper-laden and arduous process. The efficiencies in this area are enormous when electronic or digital signatures are used and integrated with an electronic trial master file (eTMF). Routing wet signatures electronically is not the same as electronic or digital signatures.
Although some areas have made the transition and are well established, others clearly still are identifying needs. The human effort involved in keeping up with some of these processes is enormous. Realistically, study start-up times can be reduced by 30% to 60% by eliminating paper. Site productivity, not surprisingly, elevates when the amount of time pushing papers decreases.
The old paper processes simply cannot keep up with scientific innovation. The FDA’s Critical Path Initiative (CPI) recognized 10 years ago the gap between scientific discovery and innovative medical treatments is too wide. With administratively burdensome processes, it takes too long for a new treatment to reach the person who needs it. Evolving technologies that streamline processes can be a big part of closing that gap. Paperless clinical trials are part of the solution.
Ashley Tointon directs patient engagement programs at ePharma Solutions, combining traditional methods with innovative, data-driven techniques to provide sponsors high-impact, cost-effective recruitment and retention programs. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry.
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