If therapeutic decisions in healthcare are to be informed by the results of clinical research, patients and prescribers must be able to trust the research evidence presented to them. In recent decades, the credibility of much of the evidence base for some of the most popular therapeutic and preventive interventions has been undermined by the identification of sponsorship bias.
The combination of sponsored trial bias and unreported results are a major concern for patient safety and clinical practice, as well as for the integrity of clinical trials.
Until recently, the distortions introduced by sponsorship bias were recognised as important but difficult to identify with certainty because of the secrecy surrounding pharmaceutical trials. Recent developments, such as relaxation of access to regulatory material,1 have led to relatively successful efforts to identify and describe sponsorship bias.
The problem of sponsorship bias was recognised a century ago. In 1917, Torald Sollmann warned of the effects of secrecy and closeness between those who manufacture drugs, those who test them and those who publicise them. As a member of the Council on Pharmacy and Chemistry of the American Medical Association (forerunner of the U.S. Food and Drug Administration), Sollmann was able to identify ‘poor quality’ and secrecy (publication bias) as major threats to the credibility of the reports submitted to the Council.
Jefferson, T. (2019). Sponsorship bias in clinical trials – growing menace or dawning realisation? James Lind Library Bulletin: Commentaries on the history of treatment evaluation (https://www.jameslindlibrary.org/articles/sponsorship-bias-in-clinical-trials-growing-menace-or-dawning-realisation/)
Publisher (Open Access): https://www.jameslindlibrary.org/articles/sponsorship-bias-in-clinical-trials-growing-menace-or-dawning-realisation/