The obstetrical research landscape: a cross-sectional analysis of clinical trials from 2007-2020
| Autor: | Irogue Igbinosa, Jecca R. Steinberg, Wendy Y. Zhang, Brannon T. Weeks, Christopher J. Magnani, Michael Richardson, Jill N. Anderson, Brandon E. Turner, Yasser Y. El-Sayed, Anna I. Girsen, Alison Conway Fitzgerald, Deirdre J. Lyell, Katelyn Chan, Sarah E. Lindsay, Griselda Reyes |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Databases Factual Obstetric studies Cross-sectional study Obstetric investigations Logistic regression Maternal-Fetal Medicine Odds Ratio Obstetric morbidity National Institutes of Health medicine Humans Industry Maternal health Registries Clinicaltrails.gov Proportional hazards model business.industry Original Research: Obstetrics Hazard ratio General Medicine United States Confidence interval Obstetrics Clinical trial Cross-Sectional Studies Research funding Clinical research Obstetric complications Emergency medicine business |
| Zdroj: | American Journal of Obstetrics & Gynecology Mfm |
| ISSN: | 2589-9333 |
| DOI: | 10.1016/j.ajogmf.2020.100253 |
| Popis: | Background Obstetric complications impact over a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetric clinical trial landscape, how it compares to other fields, or factors associated with the successful completion of obstetric trials. Objectives To characterize obstetric clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting. Study Design This is a cross-sectional study with descriptive, logistic regression and cox regression analyses of clinical trials registered on ClinicalTrials.gov. Our primary exposure variables were trial focus (obstetric or non-obstetric) and trial funding (industry, United States government or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with two primary outcomes: early discontinuation and results reporting. Results We downloaded data for all studies (n=332,417) registered on ClinicalTrials.gov from October 1, 2007 to March 9, 2020 from the Aggregate Analysis of the ClinicalTrials.gov database. We excluded studies with a non-interventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). 4,276 (1.9%) obstetric trials (i.e. interventional studies), and 219,235 (98.1%) non-obstetric trials were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government-funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetric trials increased over time (10.8% annual growth rate). Compared to non-obstetric trials, obstetric trials had a greater risk of early discontinuation (adjusted hazard ratio 1.40, 95% confidence interval: 1.21 to 1.62, p |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect