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Paper in Clinical Trials: No Trivial Problem

When it comes to data management in clinical trials, paper is not just an inconvenience – it’s a liability. The advent of eClinical technology is not driven solely by the discomfort of working in an office full of stacks of paper. Rather, the eClinical revolution is about data security, timelines, and budgets. The ability of CROs to meet their sponsors’ demands can hinge upon how big, or small, of a role paper plays in their clinical trials. EDC, which the clinical research industry is adopting at higher and higher rates, has constituted a major step toward neutralizing the danger of paper-based data capture. Now, with the development of eSource, researchers can access the tools necessary to finish the job.

The paper threat

To be clear: Paper is, in fact, inconvenient. It’s heavy, takes up space, and is prone to disorganization. But these drawbacks don’t even account for the threat it poses to data security. Experts have noted that the vast majority of non-compliance cases in the realm of data integrity stem from human error rather than intentional falsification, with reliance on paper as a leading contributor.1 After data is transferred from its paper source to an EDC, it’s safe – but until then, it’s vulnerable to all manner of error and accident. Between the capture of data at the site and its storage in an EDC, the fate of that data depends on the sheet of paper on which it’s entered. That sheet, especially in a trial with hundreds of thousands or even millions of data points, can be lost, misplaced, or accidentally destroyed.

Study timelines are another major consideration. Aside from its vulnerability to errors, paper can slow study operations to a crawl. Data can be accessed much more quickly in an EDC than it can by flipping through file cabinets and folders. And of course, in clinical research, time is money – the longer a study drags on, the higher the price tag.

A prime example of this is the time and cost associated with source data verification (SDV). This process, which entails comparing every data point in an EDC to its corresponding entry on a paper source, is extremely counterproductive to the efficiency that clinical researchers need today. Beyond the slowing effect on study timelines, SDV carries major expenses, such as travel costs for the monitors who perform the verification. When all is said and done, SDV can comprise a whopping 40% of a trial’s total budget.2 Not even risk-based monitoring, the flagship tool for mitigating the impact of SDV today, cuts paper completely out of the equation.

The eSource solution

EDC has become an invaluable resource in improving data security, reducing timelines, and keeping budgets in check. However, with the exception of the study configuration process, its benefits don’t kick in until clinical data is entered into the system. Until then, paper, in the form of source data, is still very much involved with data collection. eSource terminates that involvement. By enabling researchers to enter clinical data directly into an electronic system at the site level, it represents a breakthrough in making clinical data capture truly paper-free.

Suddenly, the problems outlined above are neutralized. While paper is easily lost or destroyed, data entered into an eSource application can sync immediately with the associated EDC and be stored in the cloud, thus ensuring superior data integrity. Moreover, as this process entails no manual transcription from source to EDC – a step vulnerable to human error – SDV is rendered irrelevant. And yes, simple convenience does play a role – site staff and data managers alike enjoy working in clinics and offices free from the clutter of folders, clipboards, and filing cabinets.

Recognizing the value of all this, Medrio has been an early leader in the advent of eSource technology, developing cloud-based eSource delivered through a suite of tablet applications and equipped with additional functionalities like offline data capture. And as the elimination of paper can relieve major burdens from the site level all the way up to the sponsor, these eSource applications are designed for the benefit of all invested parties.

Resistance to the adoption of eClinical tools persists in pockets of the clinical research industry, driven largely by complacency with paper-based data capture. But the elimination of paper is much more of a necessity than a mere luxury. At Medrio, we’ve noticed that when sponsors and CROs come to understand this, timelines and budgets tend to improve.

1 McDowall, Bob and Ratcliff, Joanne; How Important is Data Integrity to Regulatory Bodies?; PharmTech; 2 March 2016
2 Mealer, Meredith; Kittelson, John; Thompson, B. Taylor; Wheeler, Arthur P.; Magee, John C.; Sokol, Ronald J.; Moss, Mark; Kahn, Michael G.; Remote Source Document Verification in Two National Clinical Trials Networks: A Pilot Study; PLOS ONE; 5 December, 2013

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