Over the last five to 10 years, there have been attempts to standardize data collection and reporting processes across aspects of the clinical trial process. The industry has seen standardization, or attempts at standardization, in areas such as data submission, standards developed by Clinical Data Interchange Standards Consortium (CDISC), key performance indicators (KPIs) and key risk indicators (KRIs) created through various industry groups, and standardization tools for data collection, such as the risk assessment from TransCelerate. Even in the area of contracts, industry groups, such as Society for Clinical Research Sites (SCRS), have tried to influence standard payment and contract terms for investigator sites.
The one area that has had little to no attempt at standardization is the data collected in a clinical trial management system (CTMS). Historically, CTMS systems have been used as a “catch-all” for data that could not easily be collected in other clinical systems. This has varied broadly by customer need, but has included items such as adverse event (AE) notifications, resource management, asset tracking, and the highly configured investigator payments.
While many areas in CTMS may not be possible to standardize, as they are driven by individual company business processes, one could argue that the data collection processes in CTMS could be standardized to some degree. Areas such as terminology for subject and site statuses, milestone tracking, and even protocol deviations come to mind. One key area in which standardization could drive business efficiency, especially for contract research organizations (CROs) that are managing changing requirements for each sponsor, could be a monitoring trip report. While different therapeutic areas may have additional questions that need to be collected, it should be possible to standardize the majority of questions across companies in a trip report without exposing company intellectual property or introducing additional risks to a study.
How would standardization in CTMS help? First, implementation of the CTMS system would be much simpler. Second, data would be consistent across studies and CTMS systems, allowing for simplified sharing across studies, therapeutic areas, or companies, such as a CRO and pharma. Standardized data, also, would provide easier opportunities for its analysis to drive operational efficiencies and process improvements across an organization. Third, clinical research associates (CRAs) and study managers would be able to focus more on the critical safety and risks aspects of a particular study, and not on re-learning a different process for each study or each sponsor need. By considering some of the advances in machine learning and artificial intelligence (AI), there are likely even more areas that the industry could drive toward CTMS standardization.
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