Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials.

Abstract

In order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the conduct, as measured by the number and types of deviations that occurred during the execution phase. Knowledge of these facts and performance of research team would allow to effectively mitigate the occurrence of deviations. Thirty-five research protocols were rated according to a previously established complexity scoring model. Statistical analyses were performed to examine associations between protocol complexity, number of protocol/informed consent amendments vs. number/types of protocol deviations; as well as correlations with phase of the study, type of investigational product, personnel changes/experience level were assessed. Assessment of complexity score in Pearson's correlation test with the number of protocol deviations showed weak correlation, suggesting that other factors can influence protocol adherence. There was no correlation observed between number of deviations and type of study by investigational product category. In examining association between protocol deviations and number of subjects enrolled a trend was observed towards increased number of deviations once more subjects have entered the study. The higher number of protocol deviations was associated with increased number of protocol amendments (p = 0.0396), and there was no statistical significance observed between number of deviations and informed consent amendments (p = 0.5083). There was a moderate correlation detected between increased number of protocol deviations and total number of investigators on the study. Protocol adherence can be improved with effective training and retention of research coordinators, investigators and frequent internal auditing to address discrepancies and effectively implement corrective actions. Upfront training of research personnel, with subsequent monitoring of performance metrics throughout the execution phase can reduce the total number of protocol deviations, ensure data integrity and improve quality of research conducted. Engagement of all stakeholders upfront, including clinical site personnel, can help develop well-designed clinical trial protocol, avoid time consuming and costly protocol and informed consent amendments at execution phase and ensure higher quality of research conducted, while allowing to meet objectives of the trial in a more efficient manner.