Economics and industry do not mean ethical conduct in clinical trials.

Joel Lexchin

doi:10.1186/2052-3211-6-11

Abstract

Clinical trials present an ethical dilemma for pharmaceutical companies. While companies may want to undertake and report these trials in an ethical manner, negative results can significantly affect product sales. There is accumulating evidence that company-financed trials are biased in favor of the product that the company makes. Ethical conduct in this article is defined as whether the trials are conducted in the best interests of the participants and/or reported in the best interests of patients. Nine examples of how clinical trials are violating multiple articles in the Declaration of Helsinki are discussed using concrete case reports from the literature. The recognition of ethical problems in company run trials is not something new, but to date no meaningful action has been taken to resolve this issue. What is necessary is to separate the financing of clinical trials from their conduct.

Highlights

Declaration of Helsinki – articles 17, 18 and 24: “Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community...”; “Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research ...”; “...After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must seek the potential subject’s freely-given informed consent, preferably in writing
Two separate groups have looked at clinical trials submitted to the Food and Drug Administration (FDA) and whether they were subsequently published and how closely the results in the FDA submissions matched those in the published versions
Main text Declaration of Helsinki – articles 17, 18 and 24: “Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community...”; “Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research ...”; “...After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must seek the potential subject’s freely-given informed consent, preferably in writing

Summary

Background

Clinical trials form the basis for medical practice. Regulators such as the Food and Drug Administration (FDA) use them to decide whether or not to approve a new drug. Two separate groups have looked at clinical trials submitted to the FDA and whether they were subsequently published and how closely the results in the FDA submissions matched those in the published versions. In both cases, positive trials were much more likely to be published and trials that had negative results when they were reviewed by the FDA had positive results in journal publications [4,5]. Even more importantly, is the violation of multiple articles about the ethical conduct of clinical trials that are enunciated in the Declaration of Helsinki [6]

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Findings

Discussion and conclusion