Abstract
Conducting randomized controlled trials entails a prolonged, costly study start-up (SSU) process that may create significant delays. Optimizing the operational aspects of multisite trials requires identifying benchmarks in the SSU process and the potential delays associated with them. We engaged in a collaborative effort to identify and describe key SSU intervals that correspond with necessary procedures and processes for activating multisite clinical trials in the US. After developing definitions for SSU benchmarks and obtaining data from research coordinating entities, we identified factors that were significantly associated with reduced cycle times, including the use of central institutional review boards for study approval and status as a private practice or independent research site. However, small sample sizes and large proportions of missing data hamper the interpretability of our results. Future development of standard measures of SSU efficiency will be critical to analyzing and improving study initiation processes at US research sites.
Highlights
Randomized controlled trials (RCTs) are the most reliable means for assessing the balance of benefit and risk associated with medical therapies.1 conducting RCTs entails a prolonged, costly process2 that may delay access to new interventions, hamper research into new uses for existing medical products, and impair critical comparisons among alternative treatment strategies
While we recognize that there could be some duplication of studies in the data, we did not attempt to collect this data because [1] collecting this information would have been onerous since organizations tend to track studies by their own unique identifiers, and [2] we did not anticipate that the volume of duplication would be large and did not attempt to qualify it
We identified factors significantly associated with reduced cycle times, the small sample sizes for many subcategories, large proportions of missing data, and lack of standard data element definitions limit the interpretability of these results
Summary
Randomized controlled trials (RCTs) are the most reliable means for assessing the balance of benefit and risk associated with medical therapies. conducting RCTs entails a prolonged, costly process that may delay access to new interventions, hamper research into new uses for existing medical products, and impair critical comparisons among alternative treatment strategies. Current data suggest that most clinical studies involve a single research site and small numbers of participants, clinical trials capable of generating meaningful evidence that can inform practice are typically large, complex, multisite investigations. One key factor in multisite trials is the time needed to ensure that all sites have completed the administrative activities required to begin enrolling patients. Several critical checkpoints for study start-up (SSU) occur between the time a protocol is submitted to the site for review and the time that the first study participant is enrolled: institutional review board (IRB) submission, time of IRB final approval, and time of contract execution. Abbott and Grady showed that US IRBs differentially apply federal regulations and display large variations in time required to review studies and in the decisions
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