Date Published: November 25, 2008
Publisher: Public Library of Science
Author(s): An-Wen Chan
Abstract: An-Wen Chan discusses the implications of a new study inPLoS Medicine that suggests that the randomized trial literature is skewed towards reporting favorable results.
Partial Text: Although randomized trials provide key guidance for how we practice medicine, trust in their published results has been eroded in recent years due to several high-profile cases of alleged data suppression, misrepresentation, and manipulation [1–5, 39]. While most publicized cases have involved pharmaceutical industry trials, accumulating empiric evidence has shown that selective reporting of results is a systemic problem afflicting all types of trials, including those with no commercial input . These examples highlight the harmful potential impact of biased reporting on patient care, and the violation of ethical responsibilities of researchers and sponsors to disseminate results accurately and comprehensively.
In a new study published in PLoS Medicine, Lisa Bero and colleagues make an important contribution to the growing body of evidence that the randomized trial literature is skewed towards reporting favorable results . The researchers identified trials from 33 new drug applications (NDAs) for new molecular entities approved by the United States Food and Drug Administration (FDA) in 2001–2002, and compared information from FDA reviews with journal articles. By including all NDAs from a variety of specialty fields, their findings have broad generalizability to pharmaceutical trials.
Since the interests of patients are of utmost importance, it is difficult to justify why health care providers and policy makers should have access to only a biased subset of information that is substantially different from that which regulatory agencies have at their disposal. Bero and colleagues’ study highlights the importance of public access to key documents that have traditionally been deemed confidential—regulatory agency submissions and trial protocols. Both types of documents have unique properties that complement each other.
It is clear that the trial literature is biased, facilitated in part by limited oversight and difficulty in accessing detailed trial documents. Ongoing progress in trial registration and results disclosure represents a key initial step towards ensuring public access to basic information on trial methods and results [28–33]. Several journals have also acted by publishing protocols and requiring their submission with manuscripts [34–36].