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As clinical trials have become more complex and costly, traditional paper-based data management systems have increasingly proved impractical and ineffective. Cloud-based technologies fit the bill, and industry professionals have begun to recognize this reality and reap the benefits at an ever-increasing rate.
Cloud-based technologies have permeated clinical research at virtually every level. As clinical trials have become more complex and costly, traditional paper-based data management systems have increasingly proved impractical and ineffective. Paper-based systems complicate some aspects of clinical trial management more than others (e.g. monitoring, document archiving and communication between study entities)1. These challenges, along with the omnipresent need to improve efficiency and decrease the duration of trials, created the ideal environment for a novel solution to emerge. Cloud-based technologies fit the bill, and industry professionals have begun to recognize this reality and reap the benefits at an ever-increasing rate.
The swelling tide of cloud platform implementation has primarily whelmed sponsors and contract research organizations (CROs). An annual survey conducted in 2016 by Veeva Systems found that 72% of sponsors reported using some type of cloud-based technology to manage their Trial Master File (TMF) compared to 61% in 20142,3. Sponsor use of local file systems also decreased from 26% to 8% in that time span. Moreover, a separate Veeva survey reported a rise in CRO utilization of some cloud-based systems. CRO use of clinical trial management systems (CTMS) increased from 33% in 2014 to 37% in 2016 and use of purpose-built eTMF applications increased from 21% to 30% in that timeframe 4.
The evidence of this trend with sponsors and CROs has been interpreted as a burgeoning revolution across clinical trial management as an industry. However, very little research has focused on how cloud-based systems are being implemented and used in other contexts. There is evidence to suggest that these systems can actually increase workload and inefficiency at investigative sites. A 2016 study conducted by CenterWatch reported that less than 10% of investigative sites believe that clinical trial technology solutions provided by sponsors and CROs are meeting their operating needs well5. The sites gave the lowest quality, ease-of-use, and reliability ratings to clinical trial management systems and eTMF systems. These revelations pose a fundamental question: why do cloud-based data management systems benefit sponsors and CROs while simultaneously disadvantaging sites?
To answer this question, it is important to consider how cloud-based technologies are designed-or rather, who they are designed for. Many platforms, especially eTMF systems, are intended to accommodate a handful of large-scale projects. Providers tailor their platforms to facilitate every aspect of trial management, focusing on depth over breadth. These types of cloud-based systems are well-suited to the needs of sponsors and CROs but not investigative sites. This “top-down” approach to implementing cloud-based technologies creates a reflexive dynamic between sponsors and CROs at the “top” and investigative sites at the “bottom.” As sponsors and CROs continue to implement new cloud-based data management platforms, sites must consequently adapt to a growing number of novel systems. This incidental complexity on the site level represents an oft-cited source of inefficiency; the same CenterWatch study reported that on average, investigative sites work with 12 different systems to collect clinical research data5.
If paperless clinical trials are a puzzle to be solved, the industry is missing a vital puzzle piece. In the current paradigm, investigative sites are a casualty of the cloud computing revolution, not a beneficiary. The movement may require a “second wave” that focuses on ground-level solutions for those that coordinate clinical trials. On that front, useful resources may already exist. Virtual data rooms (VDRs) first emerged in the financial transactions sector in the late 1990s as part of the cloud storage industry. As early as the mid-2000s, VDR providers began developing life science platforms to address the challenges faced by healthcare entities managing and sharing protected health information (PHI) electronically. These platforms function as secure online repositories to store and share documents. VDRs can mitigate some of the most significant challenges that investigative sites face-communication, data security, file organization, document archiving, and preparedness for regulatory audits.
Cloud-based technologies can help solve some of the most important and endemic problems that exist in clinical trial management. However, the current application model does not function effectively in many contexts. More research should be conducted to understand how these systems affect processes at the ground level, particularly with investigative sites, institutional review boards (IRBs) and university-affiliated clinical research professionals (CRPs). These insights must be included in the conversation about how to design and apply cloud-based technologies going forward. The industry needs to develop a new approach in order to empower CRPs at every level to experience the benefits of these systems, and in so doing, help solve the puzzle of paperless trials.
Colton Castle is a Certified Clinical Research Coordinator in Fort Worth, TX.
1“Intralinks Studyspace Electronic Investigator-Controlled Site File (eISF).” White Paper. Intralinks. Web.
2Veeva Systems. “Veeva 2016 Paperless TMF Survey”. Survey. 2016.
3Veeva Systems. “Veeva 2014 Paperless TMF Survey: An Industry Benchmark”. Survey. 2014.
4Veeva Systems. “Veeva 2016 Paperless TMF Survey: CRO Report”. Survey. 2016.
5“New CenterWatch Study Finds That E-clinical Technologies Are Increasing Investigative Site Work Burden and Performance Inefficiencies”. The CenterWatch Monthly. CenterWatch, May 2016. Web.