DSRCT has significant IHC expression of AR and c-Kit in heavily pre-treated patients. The presence of significant AR expression in 37% suggests that these patients could possibly respond to CAB. The significance of c-Kit expression in 35% of DSRCT patients is unknown and warrants further investigation.

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<0.0001) and similar odds of results reporting (adjusted odds ratio 0.89, 95% confidence interval: 0.72 to 1.10, p=0.19). Among obstetric trials funders after controlling for confounding variables, United States government-funded trials were at lowest risk of early discontinuation (US government adjusted hazard ratio 0.23, 95% confidence interval 0.07 to 0.69, p=0.009, industry reference; academic adjusted hazard ratio 1.04, 95% confidence interval 0.62 to 1.74, p=0.88). Academic-funded trials had the lowest odds of results reporting after controlling for confounding variables (academic institutions adjusted odds ratio 0.39, 95% confidence interval 0.22 to 0.68, p=0.0009; industry reference; US government adjusted odds ratio 1.06 95% confidence interval 0.53 to 2.09, p=0.87). Conclusions Obstetric trials represent only 1.9% of all clinical trials in ClinicalTrials.gov and have ...

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Introduction Erectile dysfunction (ED) is a common medical condition that requires high-quality evidence to guide clinical practice; however, systematic reviews (SRs) and meta-analyses (MAs) often vary in quality, raising concerns regarding the validity of their results. Aim To perform an objective analysis of SRs and MAs in ED treatment and management and to report on the quality of published literature. Methods A comprehensive search in PubMed/MEDLINE and EMBASE of 12 high-impact urology journals was used to identify relevant publications. 2 authors independently performed searches, screened citations for eligibility, extracted data for analysis, and graded methodologic quality using A Measurement Tool to Assess Systematic Reviews (AMSTAR) criteria. Main Outcome Measures The main outcome was AMSTAR score, which is a validated tool to evaluate the quality of SRs and MAs. Results 31 publications met inclusion criteria and were included in the analysis. The mean AMSTAR score (± SD) among all publications was 6.5 (±2.2) of 11, reflecting “fair to good” quality. 74.2% of systematic reviews and meta-analyses focused on pharmaceutical therapy for ED, with 51.6% studying the effect of phosphodiesterase-5 inhibitors. Only 1 SR/MA studied intracavernosal injection therapy and vacuum erection devices. No publications studied intraurethral injection therapy or implantable penile prostheses. Although not statistically significant, there has been a trend of increasing quality of SRs/MAs over time (P = .072). Clinical Implication The methodologic quality of SRs/MAs should be assessed to ensure high-quality evidence for clinical practice guidelines in ED treatment and management. Strength & Limitation The data showed that methodologic quality of SRs/MAs in the treatment and management of ED is increasing over time. 12 high-impact urology journals were included in our search, which may introduce selection bias in our results. Conclusions This review highlights a need for increased effort to study second- and third-line treatments for patients who fail oral therapy.