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 drug-favorable 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.