Industry funded clinical trials: bias and quality

Abstract

The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

Keywords::

• Clinical trials
• Conflict of interest
• Industry sponsorship
• Misconduct
• Quality

Transparency

Declaration of funding

A.D.P. has written this article in his free time. No funding was provided by Pfizer Inc. or other for-profit or non-for-profit entities. This article expresses the author’s views and does not necessarily reflect the position of Pfizer Inc. or of any other institution with which he is affiliated.

Declaration of financial/other relationships

The author is employed by Pfizer, in the Clinical Development and Medical Affairs Department of the Specialty Care Business Unit; he also is adjunct professor at Columbia University and visiting professor at Drexel University.