Alexa Swailes1, Megha Gupta2, Suneet P Chauhan2, Joshua Kesterson1, Allen Kunselman1, Stephen Wagner3. 1. Department of Obstetrics and Gynecology, The Milton S Hershey School of Medicine, The Pennsylvania State University College of Medicine, Hershey, PA, United States of America. 2. Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, United States of America. 3. Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, United States of America. Electronic address: stephen.m.wagner@uth.tmc.edu.
Abstract
PURPOSE: The aim of our review was to ascertain factors associated with the successful completion of a randomized controlled trial in gynecological oncology. MATERIALS AND METHODS: This retrospective cohort study utilized data collected from the National Institutes of Health's US National Library of Medicine database on ClinicalTrials.gov. Data was collected over a five year period (2009-2013). Utilizing the search terms under the National Institutes of Health recommended "Studies by Topics" gynecological oncology studies were identified. Randomized controlled trials were selected for based on intervention and randomization criteria. Elements were then compared with statistical analysis performed using SASS. RESULTS: As of September 1st 2018, 149 of the 318 identified randomized controlled trials were successfully completed over a median length of 44 months (IQR 30.0-55.0). Completed randomized controlled trials were more likely to be performed at single centers (p < 0.005). Interventional, drug and device trials were not significantly more likely to be completed. There was no difference in funding sources for completed or not completed randomized controlled trials. CONCLUSIONS: Prospective randomized trials are essential for establishing the standard of care in clinical medicine. They are, however, time and resource intensive. Herein we have attempted to identify factors associated with successful and timely completion of gynecologic oncology randomized controlled trials including site of origin, number of participating sites, funding source, intervention type, enrollment size, and study length; however, none of these factors were observed to have an association with increased rates of trial publication.
PURPOSE: The aim of our review was to ascertain factors associated with the successful completion of a randomized controlled trial in gynecological oncology. MATERIALS AND METHODS: This retrospective cohort study utilized data collected from the National Institutes of Health's US National Library of Medicine database on ClinicalTrials.gov. Data was collected over a five year period (2009-2013). Utilizing the search terms under the National Institutes of Health recommended "Studies by Topics" gynecological oncology studies were identified. Randomized controlled trials were selected for based on intervention and randomization criteria. Elements were then compared with statistical analysis performed using SASS. RESULTS: As of September 1st 2018, 149 of the 318 identified randomized controlled trials were successfully completed over a median length of 44 months (IQR 30.0-55.0). Completed randomized controlled trials were more likely to be performed at single centers (p < 0.005). Interventional, drug and device trials were not significantly more likely to be completed. There was no difference in funding sources for completed or not completed randomized controlled trials. CONCLUSIONS: Prospective randomized trials are essential for establishing the standard of care in clinical medicine. They are, however, time and resource intensive. Herein we have attempted to identify factors associated with successful and timely completion of gynecologic oncology randomized controlled trials including site of origin, number of participating sites, funding source, intervention type, enrollment size, and study length; however, none of these factors were observed to have an association with increased rates of trial publication.