Essential information in protocols and pharmacy manuals for investigational drug services

PURPOSE: Investigational drug services (IDS) rely on trial documentation to manage investigational products (IPs). Trial start-up can be delayed when essential information is missing. The objective of this study was to assess the completeness of information provided in protocols and pharmacy manuals for IDS. METHODS: This retrospective descriptive study was conducted in the IDS of a 500-bed mother-child university health center. Clinical trials open for recruitment as of April 14, 2023, were included. The latest versions of protocols and pharmacy manuals were evaluated for information on prohibited medications, dosage, storage, concentration, packaging, and preparation. The frequency of pharmacy manual availability was compared by sponsor type using a bilateral χ2 test. RESULTS: Sixty trials and 83 IPs were included in the study. Most trials were phase 3 trials (33/60, 55%) and targeted pediatric populations (56/60, 93%). Trials with a commercial sponsor (33/36, 92%) were significantly more likely to supply a pharmacy manual than those with institutional sponsors (13/24, 54%) (P < 0.001). Important elements that were not always present included a list of specific prohibited medications (26/76 IPs, 34%), the maximum dose (14/19, 74%), storage requirements (60/83, 72%), the concentration (69/83, 83%), and the beyond-use date after preparation (26/38, 38%). Documents seldom included elements such as rounding rules (3/23, 13%) and packaging dimensions (4/83, 5%). CONCLUSION: This study highlighted a lack in clinical trial documentation of some elements required by IDS. Comprehensive documents may expedite pharmacy start-up of clinical trials. Thorough information is needed to support participant safety and data integrity. These documentation gaps underscore the need for improved collaboration between industry sponsors and IDS.