Factors affecting the non-publication of clinical trials of prevalent urological cancer.

OBJECTIVES: Clinical trials (CTs) are critical in understanding and managing cancer. However, despite being completed, CT results are often unpublished, compromising the ability to glean useful information from them. This study aimed to evaluate factors influencing the non-publication of urological oncology clinical trials. METHODOLOGY: We conducted a comprehensive search of ClinicalTrials.gov to identify CTs focused on urological cancers completed between 2000 and 2020. We used the National Clinical Trial (NCT) identifier number to check whether the trial was published. RESULTS: 9,145 oncology CTs were conducted between 2000 and 2020, of which 8.39% (n = 767) focused on urological cancers, and 47.2% (n = 362) of these trials remained unpublished. Univariable analysis revealed that trials with a sample size of less than 50 and phase 4 were significantly associated with non-publication p < 0.001. In contrast, trials involving triple masking, a higher number of agents, and those conducted in High-Income Countries were associated with a higher likelihood of publication p < 0.05. Multivariable analysis demonstrated that trials enrolling more than 50 patients and employing three or more agents, along with triple and quadruple masking, had higher odds of being published (OR = 1.62; 95%CI (1.22-2.16), 1.89; 95%CI (1.10-3.27), 3.04; 95%CI (1.44-6.44), 5.62; 95%CI (1.72-18.37), and 5.41; 95%CI (1.76-16.67), p < 0.05, respectively). However, trials conducted in low-middle-income Countries had lower odds of publication (OR = 0.26; 95%CI (0.08-0.87), p = 0.02). CONCLUSION: We found that almost one-half (47.2%) of all completed urologic oncology clinical trials are not published in a PubMed-indexed journal. This non-publication rate represents a significant loss of scientific knowledge and progress. We identified several key variables including sample size.

Gender inequality in genitourinary malignancies clinical trials leadership.

BACKGROUND: Over the past 2 decades, there has been a growing interest in the significance of gender roles in healthcare and several efforts and initiatives have focused on increasing female representation in the medical field. Clinical trials play a very important role in shaping medical practice; moreover, the leaders of clinical trials often represent the upper echelon of researchers in any designated field. Presently, there is no data regarding women's representation in urological oncology clinical trials leadership. Therefore, the aim of this study is to examine the extent of female representation in leading urological clinical trials. METHODOLOGY: To thoroughly examine the representation of females as principal investigators (PIs) in urological cancer clinical trials between 2000 and 2020, we conducted a comprehensive search of completed trials focused on kidney, prostate, and bladder cancer on ClinicalTrials.gov. We extracted relevant information regarding the PIs and analyzed the data using univariate analyses to identify any significant differences between male and female PIs. RESULTS: A total of 9145 cancer clinical trials were conducted over the last 2 decades, and 11.3% (n = 1033) of them were urological cancer clinical trials. We were able to obtain detailed information about the principal investigators (PI) in 79.0% (n = 816) of the clinical trials, and we found that 16.8% (n = 137) of them were led by female investigators. Upon evaluating the characteristics of the PIs, female PIs had a significantly lower median age and median total citations as compared to male PIs (55.0 vs 59.0 and 5333 vs 7902; p-value < 0.001 and 0.006, respectively). However, there was no statistically significant difference between the termination rate, publication rate, funding source, cancer type, and the subject of conducting the clinical trials between male and female PIs. CONCLUSION: Between 2000 and 2020, only 16.8% of urological cancer clinical trials were led by a female PI, perhaps reflective of a low percentage of senior female researchers in the fields of urology, oncology and radiation oncology. Universities, research institutes and funding agencies should work to improve mentorship, representation and opportunities for female investigators to encourage more involvement for female researchers in these clinical trials.

Understanding the Termination of Urologic Cancer Clinical Trials: Insights and Challenges.

PURPOSE: Clinical trials are valuable evidence for managing urologic malignancies. Early termination of clinical trials is associated with a waste of resources and may substantially affect patient care. We sought to study the termination rate of urologic cancer clinical trials and identify factors associated with trial termination. METHODS: A cross-sectional search of ClinicalTrials.gov identified completed and terminated kidney, prostate, and bladder cancer clinical trials started. Trials were assessed for reasons for termination. Multivariable analyses were conducted to determine the significant factors associated with the termination. RESULTS: Between 2000 and 2020, 9,145 oncology clinical trials were conducted, of which 11.30% (n = 1,033) were urologic cancer clinical trials. Of the urologic cancer clinical trials, 25.38% (n = 265) were terminated, with low patient accrual being the most common reason for termination, 52.9% (n = 127). Multivariable analysis showed that only the university funding source odds ratio (OR) of 2.20 (95% CI, 1.45 to 3.32), single-center studies OR of 2.11 (95% CI, 1.59 to 2.81), and sample size of <50 were significant predictors of clinical trial termination OR of 5.26 (95% CI, 3.85 to 7.69); all P values are <.001. CONCLUSION: The termination rate of urologic cancer clinical trials was 25%, with low accrual being the most frequently reported reason. Trials funded by a university, single-center trials, and small trials (sample size <50) were associated with early termination. A better understanding of these factors might help researchers, funding agencies, and other stakeholders prioritize resource allocations for multicenter trials that aim to recruit a sufficient number of patients.