Sponsorship bias in clinical research

Abstract

Background: Pharmaceutical companies fund the vast majority of the clinical research that is undertaken on medications but face a conflict of interest between producing good science and results that will enhance the sales of their products.

Objectives: To document concrete examples of bias in clinical research induced by pharmaceutical industry sponsorship.

Methods: This paper uses a thematic approach to documenting the extent of these biases in the following areas: research question/topic, choice of doses and comparator agents, control over trial design and changes in protocols, early termination of clinical trials, reporting to regulatory authorities, reinterpretation of data, restrictions on publication rights, use of fake journals, journal supplements and symposia, ghostwriting, publication and reporting of results and outcomes.

Results: Bias in favour of industry is apparent in every one of the themes examined with the result that research funded by industry undermines confidence in medical knowledge.

Conclusions: Bias induced by commercial concerns can be countered in one of two ways. The first is to erect a firewall between the money and the people doing the research and the data analysis. The other approach is to develop an entirely separate funding source that is independent of the pharmaceutical industry.