TY - JOUR
T1 - Factors associated with the successful completion of randomized controlled trials in gynecological oncology
AU - Swailes, Alexa
AU - Gupta, Megha
AU - Chauhan, Suneet P.
AU - Kesterson, Joshua
AU - Kunselman, Allen
AU - Wagner, Stephen
N1 - Publisher Copyright:
© 2019
PY - 2019/11
Y1 - 2019/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85071963868&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071963868&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2019.09.007
DO - 10.1016/j.ygyno.2019.09.007
M3 - Article
C2 - 31519318
AN - SCOPUS:85071963868
SN - 0090-8258
VL - 155
SP - 283
EP - 286
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 2
ER -