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.

Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

“…Experts in gynecology have called for increased transparency in research and for more high-quality clinical trials to improve evidence-based health care. 4,7,8 To advance gynecology research, first a comprehensive understanding of the current state of clinical trials is needed. Our study addresses this need by characterizing the gynecology trial landscape and key features associated with trial completion and dissemination.…”

“…The low frequency of blinding in gynecologic oncology, family planning, and reproductive endocrinology and infertility trials likely reflects the ethical and logistical limitations in surgical, abortion, and fertility trials. The associations of multiple arms, a data safety–monitoring committee, and multiple centers with publication speak to the importance of following CONSORT (Consolidated Standards of Reporting Trials) guidelines 7 and to the potential improvement in clinical trial completion and dissemination with more robust trial design and collaboration. Initiatives across subspecialties to foster collaborations represent one option to transform the gynecology trial landscape.…”

“…45 Leading gynecologic societies could require trialists to submit predesignated outcomes and release all findings regardless of positive results. 7 Comparatively better completion of trials funded by government may model the benefits of regulation and serve as a blueprint for gynecology trial success. As gynecology research progresses, identifying and systematically addressing barriers to trial dissemination could decrease bias and expand the reach of gynecology clinical trials.…”

Challenges in Interpreting Obstetrics and Gynecology Literature

“…Based on review of 36 RCTs that were retracted or were the subjects of ongoing investigation for research misconduct, Li et al67 put forth a checklist to improve assessment of data integrity at time of trial publication. Adapted and added to from other sources, the checklist includes comparisons between the pretrial registry and manuscript, as well as assessment for plausibility (eg, study timeframe, intervention, time from study completion to manuscript, reported participants lost to follow-up) 67,68. The authors emphasize ongoing need for systematic advances in these processes.…”

Red for danger in systematic reviews?

“…[6][7][8] A blog at the journal Science provides a fascinating insight on retractions, 9 and tools are evolving better to detect fraud. 10 The scandal of poor medical research is well known. 11 We are becoming aware of the poor quality of most systematic reviews.…”