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Characteristics of clinical trials identified with the search term drug-drug interaction and registered in the ClinicalTrials.gov from 2005 to 2015

Background: Drug-drug interactions (DDIs) are one of the leading causes for market withdrawals and underlie 15-20% of adverse drug reactions requiring hospitalisation. Increasing numbers of chemical entities and more prevalent polypharmacy in ageing population emphasize the need for clinical studies of DDIs. Objectives: To review the characteristics of clinical trials on DDIs in a publicly available trial register. Methods: We performed a descriptive pilot study of clinical trials retrieved from the ClinicalTrials.gov by using the search term “drug-drug interaction” (search performed on October 16, 2005). Trials were included if they were 1) investigating the DDIs ; 2) having a ClinicalTrials.gov registration number ; 3) closed and completed in October 2015 ; 4) registered between June 23, 2005 and October 16, 2015. Data on 8 items from the World Health Organization Minimum Dataset1 and on adverse events (AEs) were abstracted by one author and verified by another. Results: Among 244 eligible trials, most were industry-sponsored (73%), started before registration (71%), and primarily interventional studies (97%). The majority of trials compared two interacting drugs (62%) and applied to healthy volunteers (78%). Pharmacokinetic parameters were primary outcome measures in 74% of trials. AEs were mostly included as secondary outcome measures (39 % vs. 5% as primary outcomes). Only a few studies (8%) had registered results, among which 16% reported serious and other AEs. Conclusion: We found a remarkably low rate of reporting of study results and AEs, as well as inadequate time of registration. Further efforts to improve transparency are needed, such as enforcing regulatory requirements for timely and complete registration, and promoting it in existing regulatory guidance on drug interaction for industry.

Characteristics ; Drug-drug interaction ; ClinicalTrials.gov

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