The Facilitated Clinical Trial Protocol Review:
Is the theory being put into Good Practice?
Streamlining and optimizing protocols is a key strategy to improving the effectiveness of clinical trials. In early 2013, the Tufts Centre for the Study of Drug Development (CSDD) completed an initial study with 10 major pharmaceutical companies to assess the governance mechanisms in place for managing the protocol streamlining process. That same year, Medidata Solutions collaborated with Tufts CSDD and conducted a follow-up study to better understand the industry-wide adoption of a particular governance mechanism: facilitated clinical trial protocol review (facilitated review) meetings. Results indicated that a large percentage of pharmaceutical and biotechnology companies have implemented this practice and have seen improvements in key clinical trial performance metrics: a decline in the number of amendments and a decrease in protocol complexity. However, the majority of respondents have noted that meetings are somewhat effective, suggesting that although facilitated reviews have positively impacted clinical trial metrics, there is still room for improvement in the facilitated review process to make meetings more effective. Suggestions for more effective meetings include training meeting facilitators and having fewer meetings where more data analyses are conducted and discussed.
Life science companies have actively been researching and developing processes to reduce protocol complexity, increase efficiency and improve feasibility to lower drug development costs. Eisenstein et al established a clinical trial expert panel to identify efficiency-enhancing practices. One recommendation was to “design trials that fit clinical practice workflow…,” (1) i.e., create clinical trial protocols that are not more complex than current standard of care (2). Correa et al corroborated these findings in their study, noting that ICU nurses on average chose a less complex insulin protocol for its efficiency in maintaining blood glucose levels when asked to select between a less complex and a more complex protocol. In the study, a smaller number of patients experienced hypoglycemic episodes following the less complex protocol compared to those following the more complex protocol (3). A growing body of literature across therapeutic areas also suggests that clinical trial complexity is a barrier to both physician and patient participation (4-6). Moreover, increasing study complexity has been associated with a decrease in overall dru ...