Article type
Abstract
Background: There is an increasing number of clinical trials sponsored by the pharmaceutical industry and researchers may tend to publish conclusions with results favourable to the sponsor when summarising the results of RCTs.
Objective: to describe and critically evaluate the conclusions of RCTs evaluating monoclonal antibodies sponsored by the pharmaceutical industry.
Methods: meta-research on the characteristics of the findings of RCTs with monoclonal antibodies as an intervention sponsored by the pharmaceutical industry. Two researchers selected and extracted the general characteristics and outcomes of interest for this study.
Results: 82 publications were considered. 79.3% (65/82) were fully funded by the pharmaceutical industry, and the sponsors held the data and publication rights in 70.7% (58/82). Among the fully sponsored RCTs, 78.5% (51/65) concluded favourably to the drug, and 30.8% (20/65) made recommendations for clinical practice, 95% (19/20) of which were favouring the drug. For partially funded RCTs, 68.8% (11/16) concluded favourably to the drug and 18.8% (3/16) recommended the drug for practice, of which 66.7% (2/3) favouring the drug. Positive direction of the effect was more present in RCTs in which the sponsor held the data and publication rights (81.0%; 47/58), compared to RCTs in which the sponsor did not (63.3%; 14/22). Only 13.4% (11/82) of the RCTs recognised the uncertainty of the estimates in the conclusions and 37.4% the need for future studies.
Conclusions: Most of the included randomised clinical trials on industry-funded monoclonal antibodies concluded in a direction of effect favourable to the drug. Practice recommendations were common, while acknowledgement of uncertainty and statements regarding the need for future studies were less frequent in the conclusions. In general, the characteristics of the conclusions were similar between fully and partially funded studies and between studies in which the industry did or did not declare the right to publish or share the data.
Relevance to patients: to properly support health care, we need systematic reviews with trustworthy results, so they need to adopt transparent reporting, funding statements and conflicts of interest declarations.
Objective: to describe and critically evaluate the conclusions of RCTs evaluating monoclonal antibodies sponsored by the pharmaceutical industry.
Methods: meta-research on the characteristics of the findings of RCTs with monoclonal antibodies as an intervention sponsored by the pharmaceutical industry. Two researchers selected and extracted the general characteristics and outcomes of interest for this study.
Results: 82 publications were considered. 79.3% (65/82) were fully funded by the pharmaceutical industry, and the sponsors held the data and publication rights in 70.7% (58/82). Among the fully sponsored RCTs, 78.5% (51/65) concluded favourably to the drug, and 30.8% (20/65) made recommendations for clinical practice, 95% (19/20) of which were favouring the drug. For partially funded RCTs, 68.8% (11/16) concluded favourably to the drug and 18.8% (3/16) recommended the drug for practice, of which 66.7% (2/3) favouring the drug. Positive direction of the effect was more present in RCTs in which the sponsor held the data and publication rights (81.0%; 47/58), compared to RCTs in which the sponsor did not (63.3%; 14/22). Only 13.4% (11/82) of the RCTs recognised the uncertainty of the estimates in the conclusions and 37.4% the need for future studies.
Conclusions: Most of the included randomised clinical trials on industry-funded monoclonal antibodies concluded in a direction of effect favourable to the drug. Practice recommendations were common, while acknowledgement of uncertainty and statements regarding the need for future studies were less frequent in the conclusions. In general, the characteristics of the conclusions were similar between fully and partially funded studies and between studies in which the industry did or did not declare the right to publish or share the data.
Relevance to patients: to properly support health care, we need systematic reviews with trustworthy results, so they need to adopt transparent reporting, funding statements and conflicts of interest declarations.