A call for more transparency of registered clinical trials on endometriosis.
In response to the pressing need for more efficacious and safer therapeutics for endometriosis, there have been numerous reports in the last decade of positive results from animal and in vitro studies of various compounds as potential therapeutics for endometriosis. A handful of these have undergone phase II/III clinical trials. Since the announcement of the International Committee of Medical Journal Editors that mandated registration as a prerequisite for publication, 57 endometriosis-related clinical trials have been registered at ClinicalTrials.gov, an Internet-based public depository for information on drug studies. Among them, 25 are listed as completed, and 2 as suspended. There are 15 completed phase II/III trials, which evaluated the efficacy of various promising compounds. Yet only three of the 15 trials (20%) have published their results. The remaining 12 (80%) studies so far have not published their findings. We argue that this apparent lack of transparency will actually not benefit the trial sponsors or the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis. Thus we call for more transparency of clinical trials on endometriosis.
Guo
Sun-Wei
SW
Renji Hospital, and the Institute of Obstetric and Gynecologic Research, Shanghai Jiao-Tong University School of Medicine, Shanghai 200001, China. hoxa10@gmail.com
Hummelshoj
Lone
L
Olive
David L
DL
Bulun
Serdar E
SE
D'Hooghe
Thomas M
TM
Evers
Johannes L H
JL
D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D004715:Endometriosis / Q000628:therapy*; D005260:Female; D006801:Humans; D011643:Publishing