engleski

Are pharmacological interventions completely described in clinical trials on drug-drug interaction from ClinicalTrials.gov?

Introduction: Complete and transparent description of interventions is a prerequisite to enable the adequate interpretation of drug- drug interactions (DDIs). The aim was to evaluate the completeness of drug intervention data for trials on DDIs registered in ClinicalTrials.gov and published in journal articles. Materials and methods: In this cross- sectional study, trials were included if they 1) primarily investigated DDIs, 2) had a National Clinical Trial (NCT) identifier, 3) were completed interventional trials by October 2015, and 4) had up to two drugs within the Intervention registration element in ClinicalTrials.gov. The quality of intervention description in the registry and matching publications was assessed using 12 items from the Template for Intervention Description and Replication (TIDieR) checklist. Results: A total of 642 eligible trials with 1180 drug interventions were analyzed. Most poorly described TIDieR items in ClinicalTrials.gov were intervention provider (0.3%), adherence strategies (0.8%), manufacturer (1.8%), location (12.1%), procedure (16.2%), brand name (28.3%) and dosage form (38.4%). Regarding 51 trials with protocol reported both in ClinicalTrials.gov and publication, less than half of interventions had clear and congruent description of procedure, dosage form and route of administration in both sources. Conclusions: Despite DDIs being an important cause of morbidity and mortality related to drug use, DDI trials did not sufficiently report important elements of interventions. To ensure patient safety in clinical practice regarding concomitant medication use, registration and publishing requirements for essential data on drug interventions should be expanded and based on the TIDieR checklist.

Clinical trials ; Data ; Transparency ; Drug interactions ; Drug interventions

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