Comparison of activation effort for hematology/oncology studies versus non-hematology/oncology studies using the investigational drug services complexity scoring tool

PURPOSE: As clinical trials become increasingly complex, investigational drug services (IDS) pharmacies face growing demands in study management. The purpose of this prospective time study was to evaluate the utility of the Vizient IDS Complexity Scoring Tool (CST) in predicting the effort required by IDS pharmacists for study activation based on the assigned CST score. By quantifying the time spent on activation activities, this study aimed to determine whether actual effort aligns with the CST-assigned score. SUMMARY: Time data were collected for the following types of study activation activities: (1) preparation of site-specific pharmacy documents and (2) computerized provider order entry setup and integration into the electronic health record. Nine pharmacists contributed to data collection between September 2024 and February 2025 for 45 new studies with activation activities during this period. For both non-hematology/oncology and hematology/oncology studies, the effort required (time spent) generally increased as study complexity increased. The task-based effort was not comparable for non-hematology/oncology studies and hematology/oncology studies of the same complexity level, with specific activities identified that distinguished the effort needed for a non-hematology/oncology vs hematology/oncology study. CONCLUSION: While the CST can estimate effort based on study complexity, it does not differentiate complexity by therapeutic area. Using real-world data based on IDS practice experience, this study confirmed that hematology/oncology studies require greater effort for certain study activation activities than non-hematology/oncology studies. There is an opportunity to continue refining the CST as a valuable tool for assessing study complexity.