Assessing Research Misconduct in Randomized Controlled Trials

Abstract

Randomized controlled trials (RCTs) serve as the pillar of evidence-based medicine and guide medical practice. Compromised data integrity in RCTs undermines the authority of this valuable tool for science and puts patients at risk. Although a large number of retractions due to data issues in obstetrics and gynecology have occurred in the past few years, many problematic RCTs could still go uncovered because in general there is insufficient willingness to envisage and confront research misconduct. In this article, we discuss the necessity of assessing research misconduct, summarize methods that have been applied in detecting previous cases of misconduct, and propose potential solutions. There is no established mechanism to monitor feedback on published articles and the current system that handles potential research misconduct is unsatisfactory. Fortunately, there are methods to assess data integrity in RCTs both with and without individual participant data. Investigations into research misconduct can be facilitated by assessing all publications from a leading author or author group to identify duplication and patterns of ongoing misconduct. There is a pressing need to improve the mechanism that investigates data manipulation. The mechanism that handles misconduct should prioritize the interests of patients and readers rather than trial authors and their institutions. An equally urgent issue is to establish mechanisms that prevent compromised trials from polluting evidence synthesis or misguiding practice.