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Establishment of an Experimental Mouse Model of Endometrioma to Study its Related Infertility
Published on: April 5, 2024
A call for more transparency of registered clinical trials on endometriosis
Sun-Wei Guo1, Lone Hummelshoj, David L Olive
1Renji Hospital, and the Institute of Obstetric and Gynecologic Research, Shanghai Jiao-Tong University School of Medicine, Shanghai 200001, China. hoxa10@gmail.com
Abstract:
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.
Insights
Developing new endometriosis treatments requires transparency. Many clinical trials show poor publication rates, hindering progress for safer and more effective endometriosis therapies.
Area of Science:
- Reproductive medicine
- Clinical trial transparency
- Endometriosis therapeutics
Background:
- Numerous preclinical studies suggest potential endometriosis therapeutics.
- A significant number of endometriosis-related clinical trials are registered.
- There is a critical need for improved endometriosis treatments.
Purpose of the Study:
- To assess the publication rates of completed phase II/III clinical trials for endometriosis.
- To highlight the impact of low publication transparency on endometriosis research.
Main Methods:
- Analysis of endometriosis clinical trials registered on ClinicalTrials.gov.
- Examination of publication status for completed phase II/III trials.
Main Results:
- 57 endometriosis trials registered; 15 completed phase II/III trials.
- Only 3 (20%) of 15 completed phase II/III trials have published results.
- 12 (80%) completed phase II/III trials remain unpublished.
Conclusions:
- Low publication rates for endometriosis clinical trials represent a significant transparency issue.
- This lack of transparency may impede the development of novel endometriosis therapies.
- Increased transparency in endometriosis clinical trial reporting is urgently needed.
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