Effectiveness of a short video-based educational intervention on factors related to clinical trial participation in adolescents and young adults: a pre-test/post-test design

Abstract Background Poor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities. Efforts to address barriers to enrollment have been predominantly focused on adult diseased populations. Because older adults may already have established attitudes, it is imperative to identify strategies that target adolescents and young adults. The purpose of this study was to test the effectiveness of an educational video on factors related to clinical trial participation among a healthy adolescent and young adult population. Methods Participants completed a 49-item pre-test, viewed a 10-min video, and completed a 45-item post-test to assess changes in attitudes, knowledge, self-efficacy, receptivity to, and intention to participate (primary outcome) in clinical trials. Descriptive statistics, paired samples t-tests, and Wilcoxon signed-rank tests were conducted. Results The final analyses included 935 participants. The mean age was 20.7 years, with almost 70% aged 18 to 20 years. The majority were female (73%), non-Hispanic (92.2%), white (70%), or African American (20%). Participants indicated a higher intention to participate in a clinical trial (p < 0.0001) and receptivity to hearing more about a clinical trial (p < 0.0001) after seeing the video. Intention to participate (definitely yes and probably yes) increased by an absolute 18% (95% confidence interval 15–22%). There were significant improvements in attitudes, knowledge, and self-efficacy scores for all participants (p < 0.0001). Conclusions The results of this study showed strong evidence for the effectiveness of a brief intervention on factors related to participation in clinical trials. This supports the use of a brief intervention, in a traditional educational setting, to impact the immediate attitudes, knowledge, self-efficacy, and intention to participate in clinical trial research among diverse, healthy adolescents and young adults.https://deepblue.lib.umich.edu/bitstream/2027.42/146769/1/13063_2018_Article_3097.pd

Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial

PURPOSE Immunotherapy and chemotherapy combinations have shown activity in endometrial cancer, with greater benefit in mismatch repair (MMR)-deficient (dMMR) than MMR-proficient (pMMR) disease. Adding a poly(ADP-ribose) polymerase inhibitor may improve outcomes, especially in pMMR disease. METHODS This phase III, global, double-blind, placebo-controlled trial randomly assigned eligible patients with newly diagnosed advanced or recurrent endometrial cancer 1:1:1 to: carboplatin/paclitaxel plus durvalumab placebo followed by placebo maintenance (control arm); carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib placebo (durvalumab arm); or carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib (durvalumab + olaparib arm). The primary end points were progression-free survival (PFS) in the durvalumab arm versus control and the durvalumab + olaparib arm versus control. RESULTS Seven hundred eighteen patients were randomly assigned. In the intention-to-treat population, statistically significant PFS benefit was observed in the durvalumab (hazard ratio [HR], 0.71 [95% CI, 0.57 to 0.89]; P = .003) and durvalumab + olaparib arms (HR, 0.55 [95% CI, 0.43 to 0.69]; P < .0001) versus control. Prespecified, exploratory subgroup analyses showed PFS benefit in dMMR (HR [durvalumab v control], 0.42 [95% CI, 0.22 to 0.80]; HR [durvalumab + olaparib v control], 0.41 [95% CI, 0.21 to 0.75]) and pMMR subgroups (HR [durvalumab v control], 0.77 [95% CI, 0.60 to 0.97]; HR [durvalumab + olaparib v control] 0.57; [95% CI, 0.44 to 0.73]); and in PD-L1-positive subgroups (HR [durvalumab v control], 0.63 [95% CI, 0.48 to 0.83]; HR [durvalumab + olaparib v control], 0.42 [95% CI, 0.31 to 0.57]). Interim overall survival results (maturity approximately 28%) were supportive of the primary outcomes (durvalumab v control: HR, 0.77 [95% CI, 0.56 to 1.07]; P = .120; durvalumab + olaparib v control: HR, 0.59 [95% CI, 0.42 to 0.83]; P = .003). The safety profiles of the experimental arms were generally consistent with individual agents. CONCLUSION Carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab with or without olaparib demonstrated a statistically significant and clinically meaningful PFS benefit in patients with advanced or recurrent endometrial cancer

Climate Absolute Radiance and Refractivity Observatory (CLARREO) Pathfinder Mission: Status Overview

The Climate Absolute Radiance and Refractivity Observatory (CLARREO) is a Tier 1 mission recommended by the NRC Decadal Survey 2007. The foundation of CLARREO is the ability to produce highly accurate climate records to test climate projections in order to improve models and enable sound policy decisions. The CLARREO mission accomplishes this critical objective through accurate SI-traceable decadal observations that are sensitive to many of the key climate parameters such as radiative forcings, climate responses, and feedbacks. Uncertainties in these parameters drives uncertainty in current climate model projections. In 2016, the CLARREO project received funding for a Pathfinder mission to demonstrate essential measurement technologies required for the full mission. The appropriated funds support the flight of one instruments -- a Reflected Solar (RS) spectrometer, hosted on the International Space Station (ISS) in the 2020 time frame. The CLARREO Pathfinder (CPF) payload will be integrated with the ExPA with location on the ISS, slotted on the ExPRESS logistics carrier (ELC-1). The CPF provides high accuracy spectral reflectance measurements using an RS spectrometer operating between 350 and 2300 nm with continuous spectral coverage (\u3e 95% of reflected solar energy) with uncertainty \u3c 1% (k=2). The reflected solar spectrometer will be capable of pointing to the moon and sun for calibration, as well as tracking time/angle/space-matched observations for reference inter-calibration of other on-orbit radiometers and surface sites. The CPF will provide Earth nadir observations between 52 N and 52 S latitude with full diurnal cycle sampling in approximately 1 month. The CPF will reduce risks of the full CLARREO mission by demonstrating higher accuracy, SI-traceablity, on-orbit calibration approaches and demonstrating that high-accuracy reference inter-calibration with other on-orbit sensors (CERES, VIIRS, CrIS) is achievable

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials:Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.</p

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials:Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.</p