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Sponsorship of oncology clinical trials in the United States according to age of eligibility.

ABSTRACT: BACKGROUND:The sponsorship mix of trials relevant to young people with cancer has not been reported. Understanding this sponsorship mix may have implications for policies and regulations related to pediatric cancer drug development. METHODS:We analyzed sponsorship of interventional trials first opened in the United States from 2007 to 2018 using the ClinicalTrials.gov registry. A total of 51 781 trials across non-oncology disciplines and 18 431 oncology trials were classified according to lower age of eligibility (?18 years vs < 18 years). Studies were stratified according to sponsorship (industry vs non-industry). Trial characteristics were compared by sponsorship category. Trends in sponsorship were tracked over time. RESULTS:Within oncology trials for patients ? 18 years, sponsorship was 33% industry and 67% non-industry. Among oncology trials that included patients < 18 years, sponsorship was 16.6% industry and 83.4% non-industry (P < .001). 15.5% of industry-sponsored trials in non-oncology disciplines included patients < 18 years, whereas only 5.2% of industry-sponsored oncology trials were open to patients < 18 years (P < .001). Relative to trials with non-industry sponsors, there was a statistically significant increase in industry sponsorship of oncology trials that included patients < 18 years over time (P < .001). Trial characteristics differed significantly according to sponsor type regardless of age of eligibility. CONCLUSIONS:Interventional oncology trials that include patients < 18 years are less likely to be industry-sponsored compared to oncology trials exclusively in patients ? 18 years. Compared to other medical disciplines, a smaller proportion of industry-sponsored oncology trials included patients < 18 years. Trial sponsorship is associated with differential trial characteristics, such as trial duration and number of patients enrolled, regardless of age.

SUBMITTER: Neel DV

PROVIDER: S-EPMC7333829 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Sponsorship of oncology clinical trials in the United States according to age of eligibility.

Neel Dylan V DV Shulman David S DS Ma Clement C Bourgeois Florence F DuBois Steven G SG

Cancer medicine 20200429 13

<h4>Background</h4>The sponsorship mix of trials relevant to young people with cancer has not been reported. Understanding this sponsorship mix may have implications for policies and regulations related to pediatric cancer drug development.<h4>Methods</h4>We analyzed sponsorship of interventional trials first opened in the United States from 2007 to 2018 using the ClinicalTrials.gov registry. A total of 51 781 trials across non-oncology disciplines and 18 431 oncology trials were classified acco ...[more]

PMID: 32351000

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Project description:To ensure generalizability of clinical research results, it is important to enroll a heterogeneous population that is representative of the target clinical population. Earlier studies have found regional variation in participation in human immunodeficiency virus (HIV) clinical trials, with the lowest rates seen in the southern United States. Rates of new HIV diagnoses are highest in the South, highlighting the need for in-depth understanding of disparities in clinical trial participation. We evaluated whether regional variation in study participation remains, and describe factors that facilitate or prevent HIV clinical trial participation by region.A one-time, anonymous, bilingual, self-administered survey was conducted among HIV-infected adults receiving HIV care at all 47 domestic AIDS Clinical Trials Group clinical research sites, with a goal of completing 50 surveys per site. ?(2) tests were used to evaluate differences in knowledge of and participation in HIV clinical trials by region, including Northeast, Midwest, South, and West regions. Multivariable logistic regression was used to estimate odds ratios and 95% confidence intervals (CIs) for the effect of region on knowledge of and participation in HIV clinical trials.Of 2263 completed surveys, 2125 were included in this analysis. The proportion of respondents in the South who reported knowledge of studies (66%) was significantly lower than in the Northeast (76%), Midwest (77%), and West (73%) (P = 0.001). Respondents in the South also were the least likely group to report ever having tried to or having participated in a research study (51%) compared with respondents in the Northeast (60%), Midwest (57%), and West (69%; P < 0.001). After adjusting for age, sex, education, race/ethnicity, tobacco use, and alcohol use, the odds ratio for knowledge of and participation in clinical trials for the Northeast (1.36; 95% CI 1.07-1.72) and West (1.85; 95% CI 1.39-2.45) remained significant compared with the South. African American respondents in the South were the most likely population group to report not understanding research studies (15%) as a reason for not participating, compared with the Northeast (9%), Midwest (8%), and West (6%; P < 0.001).Significant regional variations in knowledge of and participation in HIV clinical trials exist. Our results suggest that increasing awareness and understanding of research studies, particularly among African Americans in the South, may facilitate HIV clinical trial participation that is more representative of the HIV-infected population across the United States.

Project description:Importance:Transoral endocrine surgery (TES) allows thyroid and parathyroid operations to be performed without leaving any visible scar on the body. Controversy regarding the value of TES remains, in part owing to the common belief that TES is only applicable to a small, select group of patients. Knowledge of the overall applicability of these procedures is essential to understand the operation, as well as to decide the amount of effort and resources that should be allocated to further study the safety, efficacy, and value of these operations. Objective:To determine what percentage of US patients undergoing thyroid and parathyroid surgery are eligible for TES using currently accepted exclusion criteria. Design, Setting, and Participants:Cross-sectional study of 1000 consecutive thyroid and parathyroid operations (with or without neck dissection) performed between July 1, 2015, and July 1, 2018, at 3 high-volume academic US thyroid- and parathyroid-focused surgical practices (2 general surgery, 1 otolaryngology-head and neck endocrine surgery). Eligibility for TES was determined by retrospectively applying previously published exclusion criteria to the cases. Main Outcomes and Measures:The primary outcome was the percentage of thyroid and parathyroid cases eligible for TES. Secondary outcomes were a subgroup analysis of the percentage of specific types of cases eligible and the reasons for ineligibility. Results:The mean (SD) age of the 1000 surgical patients was 53 (15) years, mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 29 (7), and 747 (75.0%) of the patients were women. Five hundred fifty-eight (55.8%) of the patients were eligible for TES. Most patients with thyroid nodules with cytologically indeterminate behavior (165 of 217 [76.0%]), benign thyroid conditions (166 of 240 [69.2%]), and primary hyperparathyroidism (158 of 273 [57.9%]) were eligible for TES, but only 67 of 231 (29.0%) of patients with thyroid cancer were eligible. Among all 1000 cases reviewed, previous neck operation (97 of 441 [22.0%]), nonlocalized primary hyperparathyroidism (78 of 441 [17.7%]), and need for neck dissection (66 of 441 [15.0%]) were the most common reasons for ineligibility. Conclusions and Relevance:More than half of all patients undergoing thyroid and parathyroid surgery in this study were eligible for TES. This broad applicability suggests that a prospective multicenter trial is reasonable to definitively study the safety, outcomes, and cost of TES.

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Sponsorship of oncology clinical trials in the United States according to age of eligibility.

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Sponsorship of oncology clinical trials in the United States according to age of eligibility.

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