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In order to manage critical clinical trial information, sponsors and CROs typically implement a strict data management structure...
In order to manage critical clinical trial information, sponsors and CROs typically implement a strict data management structure that allows them to input data while maintaining administrative control over the trial. Historically, the industry has turned to Clinical Trial Management Systems (CTMS) at an enterprise level allowing sponsors to maintain all relevant information in one central database. The benefits include allowing sponsors to see all of their information centrally without having to seek answers from outside sources. While these systems quickly became ubiquitous in clinical research, the rapidly advancing technical world has threatened the backbone of how CTMS systems are utilized.
For most companies, installing a CTMS comes at a heavy cost. A sponsor can spend anywhere from $2-$10 million depending on the size of the company, the number of users, and which vendor/modules are selected. Included in that cost is an invasive process analysis, installation, and configuration effort that often takes several months to years to complete. The CTMS may provide tools the Sponsor desires at the moment, but as technology develops, the approach to capturing clinical trial data needs to change as well. Maintaining and upgrading an enterprise CTMS becomes prohibitive as sponsors are hesitant to invest the time and money in new technology and become trapped using a low functioning system that doesn’t provide the functionality they need. Users of enterprise type CTMSs are either dependent upon a vendor’s enhancement/upgrade schedule or are forced to go down a difficult software/database integration effort. This cycle of struggling with stale technology continues and sponsors end up suffering through it because it’s too expensive to change.
One simple example of this evolution is tracking subject enrollment. Historically, sponsors and CROs would request periodic (frequent) enrollment updates from sites and summarize manually and with spreadsheets. Of course, the advent of CTMSs provided a tool to facilitate this and to allow tabulation and analysis of data across sites, studies, programs, etc. Monitoring tools and Electronic Data Capture (EDC) systems further improved enrollment tracking, but the receipt and integration of the data was not always timely. Interactive Response Technology (IRT) systems came along with the primary goal of managing subject and drug randomization and drug supply and expiry management. A fortunate consequence of IRT systems is that they typically are the first that are “aware” of subject randomization actions and are usually the most accurate for enrollment counts. Companies that use multiple technologies have to deal with significant confusion as different parts of the organization use different systems to account for subject enrollment. That is, data management and statistics would typically use the EDC system, clinical operations management might use the CTMS, and study managers would likely rely on the IRT system. Comprehensive accounting of subjective enrollment is further complicated by the fact that different studies utilize different combinations of technology over time, so having a single, reliable source of subject enrollment across all studies is difficult, at best.
Extending this example across multiple processes and applications, it is easy to see just how complicated clinical operations management has become. Too often, sponsors and CROs are forced choose between process disruption, software upgrading and validation, system functionality, and advanced data capture. With the ever growing discontinuity between enterprise CTMSs and newer software and technologies, there needs to be a different approach for how data is being collected and managed. A new approach to clinical operations software integration is needed that allows use of best-in-class modules that are easily integrated and seamlessly share relevant data. The concept of a central CTMS shouldn’t change, but the development approach must accommodate for the advances in technology in a phased approach to integrating new technologies. It appears as though the days of a single, enterprise CTMS are rapidly coming to an end.
This article was originally published on Inside Y Prime