Use of a secure mobile application to inform clinicians on adverse event management and drug-drug interactions for ribociclib: Experiences with CT scholar in ribociclib clinical trials.

Abstract

134 Background: Understanding and gaining familiarity with the adverse event (AE) and drug-drug interaction (DDI) potential of novel agents can be challenging, cumbersome, and time consuming for clinicians. A comprehensive and secure AE management/DDI mobile application (CT Scholar [Novartis Pharmaceuticals Corp]) was developed to ease the management of clinical trial participants with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer receiving ribociclib. Methods: CT Scholar was designed specifically for the ribociclib clinical program to provide easy access to information on AE and DDI management. The AE management module characterizes and quickly informs drug-specific AE management based on protocol guidelines and supportive care guidance. The DDI module includes a database of > 100 drugs searchable by both trade and generic name. Number of application visits, unique users, and screen views were monitored from Jan to Sept 2016. Results: There were 1055 visits to CT Scholar (117/month) by 145 unique users (28/month), with 5764 screen views (640/month) and 5.5 screens viewed/visit. Among the most-viewed modules were hematologic AE management (1132 views), gastrointestinal AE management (771), and DDI (734). Diarrhea, neutropenia, and nausea were the most viewed submodules (308, 230, and 205 views, respectively). The information on CT Scholar was consistently shown to be accessed more quickly than information obtained from printed clinical protocols. No patients discontinued from the ribociclib studies due to AEs following the introduction of CT Scholar. Conclusions: CT Scholar was widely used by clinicians, and it responded to their needs by providing essential information, especially on prevalent AEs, which could be easily updated and rapidly accessed. Additionally, CT Scholar provides a platform showing how technology can assist clinicians and patients in managing care during a trial, which can inform the development of future supportive materials.

Improvement Initiative to Develop and Implement a Tool for Detecting Drug-Drug Interactions During Oncology Clinical Trial Enrollment Eligibility Screening

“…A tool optimized for clinical trial enrollment screening would use language familiar to clinical research staff and could screen only for interactions involving the trial drug. However, DDI screening tools designed specifically for clinical trial enrollment are not readily available (15). The purpose of this quality improvement study was to utilize a multi-stage approach to develop a DDI screening tool specifically designed for multi-site oncology clinical trial enrollment screening and determine usability of the tool at diverse sites within an NCTN group.…”