Dataset Information

Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners.

ABSTRACT: Background and Aims:There are currently several recruitment challenges in randomized controlled trials (RCTs) for inflammatory bowel disease (IBD), which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors that could influence future recruitment strategies. Methods:We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an RCT of medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated in an RCT during each calendar year from 2011 to 2018 and accessed Clinicaltrials.gov to determine the number of active RCTs for IBD therapies per year during that same period. Results:A total of 14,747 patients with IBD were included in the analysis and 1116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation included following at an academic institution [odds ratio (OR) = 1.8; 95% confidence interval (CI) 1.51-2.04) and age 36-75 (OR = 1.7; 95% CI 1.46-1.92). Patients with Crohn's disease were more likely to participate than those with ulcerative colitis (OR = 1.5; 95% CI 1.35-1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR = 2.6; 95% CI 2.19-2.99), IBD-related surgery (OR = 2.5; 95% CI 2.24-2.87), biologic exposure (OR = 3.2; 95% CI 2.76-3.65), and "Poor" or worse quality of life (OR = 1.7; 95% CI 1.45-1.93). Steroid-free remission was associated with a lower likelihood of RCT participation (OR = 0.6; 95% CI 0.53-0.70). Although the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort. Conclusions:RCT participation declined within this cohort. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean disease activity scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-tumor necrosis factor (TNF) exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

SUBMITTER: Johnson C

PROVIDER: S-EPMC7207803 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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:High summer temperatures in extratropical areas have an impact on the public's health, mainly through heat stress, high air pollution concentrations, and the transmission of tropical diseases. The purpose of this study is to examine the current characteristics of heat events and future projections of summer apparent temperature (AT)-and associated health concerns-throughout the southeastern United States. Synoptic climatology was used to assess the atmospheric characteristics of extreme heat days (EHDs) from 1979-2015. Ozone concentrations also were examined during EHDs. Trends in summer-season AT over the 37-year period and correlations between AT and atmospheric circulation were determined. Mid-century estimates of summer AT were calculated using downscaled data from an ensemble of global climate models. EHDs throughout the Southeast were characterized by ridging and anticyclones over the Southeast and the presence of moist tropical air masses. Exceedingly high ozone concentrations occurred on EHDs in the Atlanta area and throughout central North Carolina. While summer ATs did not increase significantly from 1979-2015, summer ATs are projected to increase substantially by mid-century, with most the Southeast having ATs similar to that of present-day southern Florida (i.e., a tropical climate). High ozone concentrations should continue to occur during future heat events. Large urban areas are expected to be the most affected by the future warming, resulting from intensifying and expanding urban heat islands, a large increase in heat-vulnerable populations, and climate conditions that will be highly suitable for tropical-disease transmission by the Aedes aegypti mosquito. This nexus of vulnerability creates the potential for heat-related morbidity and mortality, as well as the appearance of disease not previously seen in the region. These effects can be attenuated by policies that reduce urban heat (e.g., cool roofs and green roofs) and that improve infrastructure (e.g. emergency services, conditioned space).

Dataset Information

Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets