Delayed publication of clinical trials in gynecologic oncology.

Autor: Salinaro JR; Program in Women's Oncology, Women & Infant's Hospital, Brown University, Providence, RI, United States of America. Electronic address: Jsalinaro@wihri.org., Rossi EC; Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Health System, Durham, NC, United States of America., Penvose KN; Duke University School of Medicine, Duke University Health System, Durham, NC, United States of America., Zhang Y; Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, TX, United States of America., Darling AJ; Department of Obstetrics and Gynecology, Duke University Health System, Durham, NC, United States of America.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2024 Apr; Vol. 183, pp. 74-77. Date of Electronic Publication: 2024 Mar 30.
DOI: 10.1016/j.ygyno.2024.03.018
Abstrakt: Objectives: Delays in clinical trial publication can hinder timely implementation of evidence-based practices. We sought to determine publication rates and time to publication for clinical trials addressing gynecologic malignancies.
Methods: All clinical trials addressing gynecologic cancers in the ClinicalTrials.gov registry with a primary completion date between 1/1/2018 and 1/1/2020 were identified. The primary outcome was publication rate. All included studies had been completed for at least 3 years. Secondary outcomes were time to publication and associations between publication rate and sponsor, cancer type, and the number and location of primary study sites.
Results: Of the 290 trials included, 161 (55.5%) had a peer-reviewed publication for the primary outcome within at least 3 years after completion. Of these, 123 had positive results (76.4%) and 38 were negative (23.6%). The average duration from primary completion to manuscript publication was 23.6 months (SD 13.9; median 21.4, IQR 15.1-32.4). Only 73 had results posted on the ClinicalTrials.gov registry (25.2%). Studies with positive findings had a significantly faster time to publication than those with negative results (22.0 mo vs 29.0 mo, p = 0.009). There was no significant difference between publication rate and funding source, cancer type, or location and number of primary sites.
Conclusions: Timely publication of clinical trials addressing gynecologic cancers remains an issue. Studies with positive findings were published faster than those with negative results, but the average publication time was still almost 2 years from trial completion. Further efforts should be made to identify and address barriers to clinical trial publication.
Competing Interests: Declaration of competing interest None.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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