The obstetrical research landscape: a cross-sectional analysis of clinical trials from 2007-2020.

作者: Jecca R. Steinberg , Brannon T. Weeks , Griselda A. Reyes , Alison Conway Fitzgerald , Wendy Y. Zhang

DOI: 10.1016/J.AJOGMF.2020.100253

关键词:

摘要: Background Obstetrical complications affect more than a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetrical trial landscape, how it compares with other fields, or factors associated successful completion trials. Objective This study aimed to characterize trials registered on ClinicalTrials.gov primary objective identifying features early discontinuation and results reporting. Study Design cross-sectional descriptive, logistic regression Cox analyses ClinicalTrials.gov. Our exposure variables were focus (obstetrical nonobstetrical) funding (industry, United States government, academic). We conducted additional exploratory including design, enrollment, therapeutic focus. examined associations 2 outcomes: Results downloaded data for all studies (N=332,417) from October 1, 2007, March 9, 2020, Aggregate Analysis database. excluded noninterventional design (n=63,697) those before 2007 (n=45,209). A total 4276 (1.9%) (ie, interventional studies) 219,235 nonobstetric (98.1%) compared. Among trials, 2.8% academic-funded 1.9% government-funded 0.4% industry-funded focused obstetrics. The quantity increased over time (10.8% annual growth rate). Compared nonobstetrical had greater risk (adjusted hazard ratio, 1.40; 95% confidence interval, 1.21-1.62; P<.0001) similar odds reporting 0.89; 0.72-1.10; P=.19). funders after controlling confounding variables, at lowest (United adjusted 0.23; 0.07-0.69; P=.009; industry reference; academic, 1.04; 0.62-1.74; P=.88). Academic-funded (academic institutions, 0.39; 0.22-0.68; P=.0009; 1.06; 0.53-2.09; P=.87). Conclusion represent only have comparatively poor completion. All stakeholders should commit increasing number improving their dissemination ensure research reflects burden disease advances maternal health.

参考文章(34)
David Moher, Kenneth F Schulz, Douglas G Altman, The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials BMC Medical Research Methodology. ,vol. 1, pp. 2- 2 ,(2001) , 10.1186/1471-2288-1-2
Monique L. Anderson, Karen Chiswell, Eric D. Peterson, Asba Tasneem, James Topping, Robert M. Califf, Compliance with Results Reporting at ClinicalTrials.gov New England Journal of Medicine. ,vol. 372, pp. 1031- 1039 ,(2015) , 10.1056/NEJMSA1409364
Nicholas M Fisk, Rifat Atun, Market failure and the poverty of new drugs in maternal health. PLOS Medicine. ,vol. 5, pp. 22- 28 ,(2008) , 10.1371/JOURNAL.PMED.0050022
Chris Stockmann, Catherine M.T. Sherwin, Gideon Koren, Sarah C. Campbell, Jonathan E. Constance, Matthew Linakis, Alfred Balch, Michael W. Varner, Michael G. Spigarelli, Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov The Journal of Clinical Pharmacology. ,vol. 54, pp. 432- 437 ,(2014) , 10.1002/JCPH.212
Françoise Baylis, Pregnant women deserve better Nature. ,vol. 465, pp. 689- 690 ,(2010) , 10.1038/465689A
Deborah A. Zarin, Tony Tse, Rebecca J. Williams, Robert M. Califf, Nicholas C. Ide, The ClinicalTrials.gov Results Database — Update and Key Issues New England Journal of Medicine. ,vol. 364, pp. 852- 860 ,(2011) , 10.1056/NEJMSA1012065
Jeanne S. Sheffield, David Siegel, Mark Mirochnick, R. Phillips Heine, Christine Nguyen, Kimberly L. Bergman, Rada M. Savic, Jill Long, Kelly E. Dooley, Mirjana Nesin, Designing Drug Trials: Considerations for Pregnant Women Clinical Infectious Diseases. ,vol. 59, ,(2014) , 10.1093/CID/CIU709
Robert M Califf, Deborah A Zarin, Judith M Kramer, Rachel E Sherman, Laura H Aberle, Asba Tasneem, Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 JAMA. ,vol. 307, pp. 1838- 1847 ,(2012) , 10.1001/JAMA.2012.3424