Research Waste in Randomized Clinical Trials: a Cross-Sectional Analysis
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Department of Internal Medicine, University of Utah, 571 E Sherman Ave, Salt Lake City, UT, USA; 2Department of Emergency Medicine, The Johns Hopkins School of Medicine, Baltimore, MD, USA; 3Department of Internal Medicine, Division of General Medicine, University of Michigan, Ann Arbor, MI, USA.
J Gen Intern Med DOI: 10.1007/s11606-019-05523-4 © Society of General Internal Medicine 2019
INTRODUCTION
Randomized clinical trials (RCT) require substantial investments from patients, investigators, and funding agencies. RCTs that fail to be completed or to report findings represent research waste, and unnecessary patient harm. Determining RCT viability is critical in allocating funds, and ClinicalTrials. gov provides a platform for investigators to post results from completed RCTs irrespective of “success,” which can influence publication.1 We sought to describe research waste in Phase 3 RCTs as indicated by inability to reach completion and insufficient reporting of results when completed.
METHODS
We examined Phase 3 (defined by ClinicalTrials.gov), interventional (non-observational), parallel, two-arm (≥ three excluded) RCTs conducted entirely in the United States. RCTs abstracted from ClinicalTrials.gov were first registered between January 1, 2013, and December 31, 2014. Dates were chosen to allow for sufficient post-completion publication to the time of abstraction. RCTs were categorized as discontinued before completion (terminated, withdrawn, or suspended), completed without results, and completed with results. Data extracted from each RCT included number of study locations, sponsor type, therapeutic modality, RCT completion status, estimated sample size, actual enrollment, availability of results on the registry, and availability of results in a manuscript. When this data was not provided in ClinicalTrials. gov, we attempted to extract it from the study protocol or published manuscript linked to the registry when possible. We compared completion rates of RCTs using χ2 tests. Statistical analyses were performed using R 3.5.3.
Received October 7, 2019 Revised October 7, 2019 Accepted October 25, 2019
RESULTS
Three hundred seventy-three RCTs in ClinicalTrials.gov met inclusion criteria (Table 1). Overall, 90 RCTs (24.1%) were discontinued before completion; 101 (27.1%) were completed without results in ClinicalTrials.gov; and 182 (48.8%) were completed with results available (Table 1). For discontinued RCTs, there was no difference in intended sample size with RCTs that were completed with results or completed without results (p = 0.37 and p = 0.49, respectively). RCTs that were discontinued had lower rates of meeting enrollment than both RCTs completed with results (p < 0.001) and completed without results (p < 0.001). Completed studies with and without results met enrollment at similar rates (p = 0.79). No discontinued RCTs were published. 108 (59.3%) of the RCTs completed with results reported in the registry were published in the peer-reviewed literature, while 22 of the 101 (21.78%) RCTs completed with
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