Conclusions of clinical trials assessing monoclonal antibodies and sponsored by pharmaceutical industry: a meta-research study

OBJECTIVE: The objective of this study was to describe and critically appraise the conclusions of randomized clinical trials assessing monoclonal antibodies sponsored by the pharmaceutical industry. METHODS: This is a meta-research study on conclusions' characteristics of randomized clinical trials with monoclonal antibodies as interventions sponsored by the pharmaceutical industry. RESULTS: A total of 82 publications were considered. Notably, 79.3% (65/82) of the trials were fully funded by the pharmaceutical industry, and sponsors had data and publishing rights in 70.7% (58/82). Among the fully sponsored studies, 78.5% (51/65) presented conclusions with a drugfavorable direction of the effect, and 30.8% (20/65) made some recommendations for clinical practice, of which 95% (19/20) were favorable to the drug. In relation to the partially funded studies, drug-favorable direction of effect was present in 68.8% (11/16) of conclusions, and 18.8% (3/16) recommended the drug for the practice, in which 66.7% (2/3) favored the drug. Positive direction of effect was more present in trials in which the sponsor owned data and publication (81.0%; 47/58), compared to trials where the funder did not (63.3%; 14/22). Only 13.4% (11/82) of included studies recognize the uncertainty in the estimates in the conclusions, and 37.4% (31/82) had a statement regarding the need for future studies. CONCLUSIONS: Most of the included randomized clinical trials on monoclonal antibodies funded by the industry concluded a drug-favorable direction of effect. Recommendations for practice were common, while recognition of uncertainty and statements regarding the need for future studies were less frequently present in the conclusion.