Participation In Clinical Trials Research Articles

Disparities in clinical drug trial participation in endometrial cancer: a real-world analysis

Racial disparities in clinical trial participation for uterine cancer have been reported. We sought to examine disparities of endometrial cancer patient participation in clinical drug trials in a contemporary, real-world population in the United States. We conducted a retrospective cohort study of patients with advanced or recurrent patients with endometrial cancer diagnosed from 2013 to 2021 using a real-world electronic health record-derived database representing approximately 800 academic and community practice sites across the United States. We used multilevel Poisson regression modeling to analyze the association of clinical drug trial participation with patient, sociodemographic, health system, and cancer factors. Of 4423 patients with endometrial cancer, 2807 (63.5%) identified as white, 649 (14.7%) Black, 78 (1.8%) Asian, and 964 (21.8%) some other race. Overall, 3.8% of patients with endometrial cancer ever participated in a clinical drug trial. High-risk histology and residence in the Southeast were associated with increased clinical trial participation (risk ratio (RR) 2.28, 95% confidence interval (CI) 1.12-4.62 and RR 2.59, 95% CI 1.26-5.3 respectively). By race, trial participants included 123 (72.4%) White, 18 (10.6%) Black, 1 (0.59%) Asian, and 28 (16.4%) some other race. While Black patients had the greatest proportion of high-risk histology, they were 50.0% less likely than white patients to participate in a clinical trial (RR 0.50, 95% CI 0.30-0.83). Black patients with endometrial cancer were disproportionately underrepresented in clinical drug trials, despite having higher rates of aggressive cancer histologies. Efforts to increase diversity in endometrial cancer clinical trial participants are needed.

Advancing Neurosurgery Through Translational Medicine: The Modern Surgeon's Role

In the dynamic field of neurosurgery, the concept of translational medicine plays a pivotal role in bridging the gap between scientific discoveries and clinical applications. This editorial delves into the evolving landscape of neurosurgery, highlighting the integral role of modern neurosurgeons in research, learning, and patient care. Translational Medicine: Connecting Bench to Bedside Translational medicine refers to the process of applying findings from basic science research to enhance human health and well-being. In neurosurgery, this often involves integrating insights from disciplines like neuroscience, genetics, and biomedical engineering into clinical practice. For example, discoveries in neuroimaging techniques or molecular biology can lead to novel treatments for neurological disorders. The Modern Neurosurgeon: A Scientist and Clinician Today’s neurosurgeon is not merely a technician but a scientist at heart. Engaging in research is not just an academic pursuit but a fundamental aspect of enhancing patient care. By actively participating in or leading research initiatives, neurosurgeons contribute to expanding the boundaries of knowledge and improving treatment outcomes. They collaborate with basic scientists, engineers, and other medical specialists to innovate and develop new therapies. Learning and Innovation Continuous learning is ingrained in the ethos of neurosurgery. Advances in technology and surgical techniques require neurosurgeons to stay abreast of the latest developments through conferences, workshops, and lifelong learning. Moreover, the feedback loop between research and clinical practice fosters an environment of continuous improvement. Lessons learned from patient outcomes inform future research directions, creating a virtuous cycle of innovation. Patient-Centric Care At its core, neurosurgery is about alleviating suffering and restoring function. Translational research allows neurosurgeons to offer more personalized treatments based on genetic, molecular, and imaging data. Tailoring therapies to individual patient profiles enhances efficacy and minimizes risks. Furthermore, participation in clinical trials enables neurosurgeons to offer cutting-edge treatments to patients who may have exhausted conventional options. Challenges and Opportunities While the integration of translational medicine into neurosurgery holds immense promise, it also presents challenges. Research endeavors require substantial resources, collaboration across disciplines, and rigorous ethical considerations. Moreover, translating laboratory findings into clinical applications demands patience and persistence. Conclusion The modern neurosurgeon’s role in translational medicine is multifaceted and indispensable. By embracing research, continuous learning, and patient-centered care, neurosurgeons not only advance the field but also improve the lives of their patients. As technology and knowledge continue to evolve, the collaboration between basic scientists and clinicians will be pivotal in shaping the future of neurosurgery, ultimately leading to better outcomes and enhanced quality of life for patients worldwide.

Gender, race, and ethnicity in lung cancer clinical trial participation: Analysis of 253,845 patients from 2002 to 2021

BackgroundLung cancer remains the greatest cause of cancer-related death, and multiple large studies have identified persistent racial disparities in lung cancer outcomes. In this study, we used public recording of lung cancer data on clinicaltrials.gov to sample age, gender, racial, and ethnic characteristics of participants in lung cancer clinical trials. MethodsClinicalTrials.gov, a US federal government repository of clinical trials, was queried for the term “lung cancer” and several related terms. A list of all studies matching these criteria was generated, and information regarding age, gender, ethnicity, and racial breakdown of participants was analyzed. Studies that did not report results to ClinicalTrials.gov or had at least one non-US site were excluded. Hypothesis testing was performed with the Student t test and χ2 test. Trends were analyzed using Spearman testing in Python (VSCode). ResultsRates of minority (ie, nonwhite) and female participation in US lung cancer clinical trials have increased significantly (P < .01) over the 20-year period from 2002 to 2021 but still do not represent parity with lung cancer incidence. Subset analysis by intervention offered did not show any significant differences in race, gender, or ethnic participation between studies that offered surgical intervention and those involving noninvasive interventions. National Institutes of Health–funded studies do not appear to have recruited any Hispanic participants, as assessed by reporting on ClinicalTrials.gov. The rates of race and ethnicity reporting also increased significantly over the study period. ConclusionsOur data demonstrate that there are persistent but improving racial and ethnic disparities in lung cancer clinical trials. Limitations of this study include poor reporting of results on clinicaltrials.gov. These findings demonstrate significant progress in the recruitment of minority participation, but also identify a significant role for policy changes to align participation with lung cancer incidence.

Implications of Global Lung Function Initiative Spirometry Reference Equations in Northeast Asian Patients With COPD

Accurate spirometry interpretation is critical in the diagnosis and management of chronic obstructive pulmonary disease (COPD). With increasing efforts for a unified approach by the Global Lung Function Initiative (GLI), this study evaluated the application of race-specific 2012-GLI and race-neutral 2022-GLI reference equations compared to Choi's reference equations, which is derived and widely used in South Korea, for spirometry interpretation in Northeast Asian patients with COPD. What are the effects of applying race-specific 2012-GLI, race-neutral 2022-GLI, and Choi's reference equations on the diagnosis, severity grade, and clinical outcome associations of COPD STUDY DESIGN AND METHODS: Serial spirometry data from the Korea COPD Subgroup Study (KOCOSS) consisting of 3,477 patients were utilized for re-analyses using 2012-GLI, 2022-GLI, and Choi's reference equations. The COPD diagnosis and severity categorization, associations with disease manifestations and health outcomes, and longitudinal trajectories of lung function were determined. Although there was strong concordance in COPD diagnosis comparing 2012-GLI, and 2022-GLI reference equations to Choi's reference equations, a notable portion of patients were reclassified to milder disease severity (17.0% and 23.4% for 2012-GLI and 2022-GLI reference equations, respectively). Relationships between FEV1 percent-predicted values calculated using 2012-GLI, 2022-GLI, and Choi's equations with clinical outcomes including dyspnea severity, exercise capacity, health-related quality of life, and frequency of exacerbations remain consistently significant. Similar annual decline rates of FEV1 and FVC percent-predicted were observed among the reference equations used, except for slower annual decline rate of FEV1 in Choi's equation compared to 2022-GLI race-neutral equation. Application of GLI reference equations for spirometry interpretation in Northeast Asian patients with COPD has potential implications on disease severity grade for clinical management and trial participation, and maintains consistent significant relationships with key disease outcomes.

53006 A Cross-Sectional Survey of Clinical Trials Knowledge, Participation, and Perspectives in an Underserved Community of Washington, DC

53006 A Cross-Sectional Survey of Clinical Trials Knowledge, Participation, and Perspectives in an Underserved Community of Washington, DC

Virus-like particles as robust tools for functional assessment: Deciphering the pathogenicity of ABCA4 genetic variants of uncertain significance

The retina-specific ABCA transporter, ABCA4, is essential for vision, and its genetic variants are associated with a wide range of inherited retinal degenerative diseases (IRDs) leading to blindness. Of the 1,630 identified missense variants in ABCA4, ∼50% are of unknown pathogenicity (variants of unknown significance, VUS). This genetic uncertainty presents three main challenges: (i) inability to predict disease-causing variants in relatives of IRD patients with multiple ABCA4 mutations; (ii) limitations in developing variant-specific treatments; and (iii) difficulty in using these variants for future disease prediction, affecting patients' life-planning and clinical trial participation. To unravel the clinical significance of ABCA4 genetic variants at the level of protein function, we have developed a virus-like particle (VLP)-based system that expresses the ABCA4 protein and its variants. We validated the efficacy of this system in the enzymatic characterization (ATPase activity) of VLPs harboring ABCA4 and two variants of established pathogenicity: p.N965S and p.C1488R. Our results were consistent with previous reports and clinical phenotypes. We also applied this platform to characterize the VUS p.Y1779F and observed a functional impairment, suggesting a potential pathogenic impact. This approach offers an efficient, high-throughput method for ABCA4 VUS characterization. Our research points to the significant promise of the VLP-based system in the functional analysis of membrane proteins, offering important perspectives on the disease-causing potential of genetic variants and shedding light on genetic conditions involving such proteins.

Association of Community-Level Social Vulnerability With Clinical Trial Discussion and Participation Among Cancer Survivors.

Community factors and structural barriers may contribute to disparities and underrepresentation in cancer clinical trials. We evaluate the influence of community-level social determinants of health, as measured by the Centers for Disease Control and Prevention Social Vulnerability Index (SVI), on disparities in cancer clinical trial discussion and participation. We performed a cross-sectional analysis of the 2021 Health Information National Trends Survey-SEER, a representative survey of cancer survivors sampled from three SEER registries. The primary outcomes included patient-reported clinical trial discussion and participation. The primary exposure was county-level SVI, linked to each survey respondent by ZIP code of residence and categorized into quintiles. Survey-weighted bivariate comparisons and multivariable logistic regression were performed to evaluate the association between SVI and clinical trial discussion and participation, adjusting for age, sex, race and ethnicity, education, income, and cancer stage. We identified 1,220 respondents residing in 153 counties with a median SVI of 0.41 (IQR, 0.27-0.62), representing a population of over 400,000 cancer survivors on weighted analysis. Of the cohort, 15.1% reported clinical trial discussion and 7.7% reported clinical trial participation. Patients who are most socially vulnerable (fifth quintile of SVI) had significantly lower odds of clinical trial discussion (odds ratio [OR], 0.36 [95% CI, 0.15 to 0.87]; P = .02) and clinical trial participation (OR, 0.15 [95% CI, 0.03 to 0.75]; P = .02) compared with patients who are least socially vulnerable (first quintile of SVI). These findings suggest interventions to identify socially vulnerable communities for expansion of clinical trial opportunities and infrastructure may be an impactful strategy toward improving diversity and representation in cancer clinical trials.

Technical factors associated with the benefit of prophylactic pancreatic stent placement during high-risk ERCP: a secondary analysis of the SVI trial dataset.

Prophylactic pancreatic stent placement (PSP) is effective for preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk cases, but the optimal technical approach to this intervention remains uncertain. In this secondary analysis of 787 clinical trial participants who underwent successful stent placement, we studied the impact of: 1) whether pancreatic wire access was achieved for the sole purpose of PSP or naturally during the conduct of the case; 2) the amount of effort expended on PSP; 3) stent length; 4) stent diameter; and 5) guidewire caliber. We used logistic regression models to examine the adjusted association between each technical factor and post-ERCP pancreatitis (PEP). Ninety-one of the 787 patients experienced PEP. There was no clear association between PEP and whether pancreatic wire access was achieved for the sole purpose of PSP (vs. occurring naturally; OR 0.82, 95%CI 0.37-1.84), whether substantial effort expended on stent placement (vs. non-substantial effort; OR 1.58, 95%CI 0.73-3.45), stent length (>5 cm vs. ≤5 cm; OR 1.01, 95%CI 0.63-1.61), stent diameter (≥5 Fr vs. <5 Fr; OR 1.13, 95%CI 0.65-1.96), or guidewire caliber (0.035 inch vs. 0.025 inch; 0.83, 95%CI 0.49-1.41). The 5 modifiable technical factors studied in this secondary analysis of large-scale randomized trial data did not appear to have a strong impact on the benefit of prophylactic pancreatic stent placement in preventing PEP after high-risk ERCP. Within the limitations of post hoc subgroup analysis, these findings may have important implications in procedural decision-making and suggest that the benefit of PSP is robust to variations in technical approach.

Gesture encoding in human left precentral gyrus neuronal ensembles.

Understanding the cortical activity patterns driving dexterous upper limb motion has the potential to benefit a broad clinical population living with limited mobility through the development of novel brain-computer interface (BCI) technology. The present study examines the activity of ensembles of motor cortical neurons recorded using microelectrode arrays in the dominant hemisphere of two BrainGate clinical trial participants with cervical spinal cord injury as they attempted to perform a set of 48 different hand gestures. Although each participant displayed a unique organization of their respective neural latent spaces, it was possible to achieve classification accuracies of ~70% for all 48 gestures (and ~90% for sets of 10). Our results show that single unit ensemble activity recorded in a single hemisphere of human precentral gyrus has the potential to generate a wide range of gesture-related signals across both hands, providing an intuitive and diverse set of potential command signals for intracortical BCI use.

Under-Representation and Under-Reporting of Minoritized Racial and Ethnic Groups in Clinical Trials on Immune Checkpoint Inhibitors.

Minoritized racial/ethnic groups are historically under-represented in cancer clinical trials, which may be exacerbated in recent trials on immune checkpoint inhibitors (ICIs). We examined the representation and reporting of the racial/ethnic composition of participants in clinical trials on ICIs. We examined English full-text trials on ICIs published from 2007 to 2022. Information on trial characteristics and racial/ethnic composition of participants was extracted from published papers or ClinicalTrials.gov. Differences in participation by publication year, ICI agent, and cancer site were analyzed. Enrollment-incidence ratio (EIR) was calculated to compare the proportion of minoritized racial/ethnic group patients in US-based trials against age-adjusted cancer incidence data available for the US population. An EIR > 1 signified over-representation, whereas an EIR <1 signified under-representation. Of the 471 trials examined, racial composition was unreported in 146 (31%), whereas Hispanic/Latinx ethnicity was unreported in 278 (59%). Only 30 (6%) trials reported race/ethnicity-specific results. In US-only trials (n = 174), White patients were over-represented (EIR, 1.20 [95% CI, 1.17 to 1.22]), whereas Hispanic/Latinx patients were the most under-represented (EIR, 0.35 [95% CI, 0.24 to 0.48]), followed by Black/African American patients (EIR, 0.66 [95% CI, 0.54 to 0.79]). Subgroup analyses consistently indicated over-representation of White patients across publication years (EIR, 1.19-1.24), ICI classes (EIR, 1.16-1.23), and cancer sites (EIR, 1.11-1.31), whereas Hispanic/Latinx patients were consistently under-represented. An upward trend of trial representation and reporting was observed for all minoritized racial/ethnic groups over time (trend P values ≤.05). Disparities in the representation and reporting of minoritized racial/ethnic groups persist in recent trials on ICIs, necessitating collaborative efforts for improved diversity and equitable cancer treatment access.

Participation in Clinical Trials Doesn't Have to Be a Lousy Experience.

Participation in Clinical Trials Doesn't Have to Be a Lousy Experience.

Introduction of a New Satellite Model for Participation in Clinical Trials in a Consortial Comprehensive Cancer Center with Four University Hospitals in Germany

Introduction: The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model. Methods: In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law). Conclusion: Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. The satellite model developed is intended to give patients broader access to medical innovations in cancer therapy.

Perspectives on Neoadjuvant Clinical Trial Participation for Patients with Kidney Cancer: A Survey-Based Examination

Background: Kidney cancer is amongst the deadliest genitourinary malignancies. Neoadjuvant systemic therapy has the potential to improve survival and overall outcomes in select patients. Enrolling patients in trials of neoadjuvant treatment for kidney cancer is challenging, which limits neoadjuvant treatment development. Objective: This study aims to develop a better understanding of the barriers patients face in kidney cancer clinical trial participation, with a particular focus on neoadjuvant trials for renal cell carcinoma. Methods: From 2022–2023, we recruited participants with a history of kidney cancer through a Qualtrics survey that was sent to the Kidney Cancer Association (KCA) and Kidney Cancer Cure (KCCure) mailing lists and social media pages. Patient responses on demographics, clinical information, and perspectives were evaluated. Results: Ninety-four individuals completed the survey. Eighty-one percent of respondents reported not participating in clinical trials due to not being informed about potential applicable trials. Importantly, many (76%) respondents reported that prevention of cancer return was a highly important reason to participate in clinical trials. Most respondents reported a willingness to undergo a kidney biopsy (59%), and/or additional appointments (58%) and surgery delays. Conclusions: Increased patient awareness about clinical trials with the potential to delay cancer recurrence may increase patient participation in clinical trials. Clinical trial design, including additional appointments or interventions and/or minor surgery delays are not major barriers to trial participation.

Early antiviral CD4 and CD8 T cell responses and antibodies are associated with upper respiratory tract clearance of SARS-CoV-2.

T cells are involved in protective immunity against numerous viral infections. Data regarding functional roles of human T cells in SARS-CoV-2 (SARS2) viral clearance in primary COVID-19 are limited. To address this knowledge gap, samples were assessed for associations between SARS2 upper respiratory tract viral RNA levels and early virus-specific adaptive immune responses for 95 unvaccinated clinical trial participants with acute primary COVID-19 aged 18-86 years old, approximately half of whom were considered high risk for progression to severe COVID-19. Functionality and magnitude of acute SARS2-specific CD4 and CD8 T cell responses were evaluated, in addition to antibody responses. Most individuals with acute COVID-19 developed SARS2-specific T cell responses within 6 days of COVID-19 symptom onset. Early CD4 T cell and CD8 T cell responses were polyfunctional, and both strongly associated with reduced upper respiratory tract SARS2 viral RNA, independent of neutralizing antibody titers. Overall, these findings provide evidence for protective roles for circulating SARS2-specific CD4 and CD8 T cells during acute COVID-19.

Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language

BackgroundTo explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English. MethodsThis retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English. ResultsCrude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001). ConclusionsOverall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.

Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide

In drug development, the use of real-world data (RWD) has augmented our understanding of patients’ health care experiences and the effects of treatments beyond clinical trials. Although electronic health record (EHR) data integration at clinical trial sites is a widely adopted practice, primarily for recruitment and data capture, a challenge to data utility is the fragmentation of health data across different sources.Linking RWD sources to each other and to trial data -- while preserving patient privacy through tokenization -- aids in filling evidence gaps with outcome data and facilitates the generalization of effects from controlled trial environments to real-world settings. This paper describes the applications of RWD linkage and how they benefit both clinical development and real-world decision-making. Trial benefits include improving interpretability and generalizability (e.g., by remediating missing data or losses to follow-up), extending follow-up beyond trial closeout, and characterizing the applicability of trial results to under-represented groups.The operational aspects of linking trial data to RWD are addressed, emphasizing the importance of using privacy-preserving record linking systems with established metrics of accuracy and precision, managing consent, and providing the necessary training and resources at trial sites to inform participants about providing access to their RWD through data linkage.

Preclinical Evidence for the Protective Capacity of Antibodies Induced by Lyme Vaccine Candidate VLA15 in People.

Vaccine candidate VLA15 is designed to protect against the dominant Borrelia genospecies-causing Lyme disease in North America and Europe. Active immunization with VLA15 has protected in the mouse model of tick challenge. VLA15 is currently under evaluation in clinical studies for the prevention of Lyme borreliosis. Mice were passively administered sera from clinical trial participants vaccinated with VLA15, or normal human serum from unvaccinated individuals as control. Posttransfer serum anti-outer surface protein A (OspA) immunoglobulin G titers were assessed by enzyme-linked immunosorbent assay. Following passive transfer, mice were challenged with Ixodes ticks colonized with Borrelia burgdorferi (OspA serotype 1) or Borrelia afzelii (OspA serotype 2) and infection was determined by serology for VlsE C6 or by polymerase chain reaction and culture to assess the presence of Borrelia bacteria. Passive transfer of immune sera prevented transmission of Borrelia from the tick vector and protected mice against challenge. Posttransfer protective threshold immunoglobulin G antibody titers were observed in this animal model of 131 U/mL for B burgdorferi (OspA serotype 1) and 352 U/mL for B afzelii (serotype 2). Passive transfer of sera from trial participants immunized with VLA15 protected mice from borreliosis in a tick challenge model. This indicates that VLA15 induces functional immune responses in people that can be linked to efficacy in a stringent preclinical model.

Using Short-Form Videos to Get Clinical Trial Newcomers to Sign Up: Message-Testing Experiment.

Recruiting participants for clinical trials poses challenges. Major barriers to participation include psychological factors (eg, fear and mistrust) and logistical constraints (eg, transportation, cost, and scheduling). The strategic design of clinical trial messaging can help overcome these barriers. While strategic communication can be done through various channels (eg, recruitment advertisements), health care providers on the internet have been found to be key sources for communicating clinical trial information to US adults in the social media era. This study aims to examine how communication source (ie, medical doctors and peers) and message framing of TikTok videos (ie, psychological and logistical framing) influence clinical trial-related attitudes, perceptions, and sign-up behaviors under the guidance of the integrated behavioral model. This study used a 2 (source: doctor vs peer) × 2 (framing: psychological vs logistical) between-participant factorial design web-based experiment targeting adults in the United States who had never participated in clinical trials (ie, newcomers). A Qualtrics panel was used to recruit and compensate the study respondents (n=561). Participants viewed short-form videos with doctors or peers, using psychological or logistical framing. The main outcome measures included perceived source credibility, self-efficacy, attitude toward clinical trial participation, behavioral intention, and sign-up behavior. Structural equation modeling was used to analyze the direct and indirect effects of message factors on the outcome variables. Source (doctor=1; peer=0) and framing (psychological=1; logistical=0) were dummy-coded. Doctor-featured messages led to greater perceived source credibility (β=.31, P<.001), leading to greater self-efficacy (95% CI 0.13-0.30), which in turn enhanced behavioral intention (95% CI 0.12-0.29) and clinical trial sign-up behavior (95% CI 0.02-0.04). Logistical barrier-framed messages led to greater self-efficacy (β=-.09, P=.02), resulting in higher intention to participate in clinical trials (95% CI -0.38 to -0.03) and improved sign-up behavior (95% CI -0.06 to -0.004). Logistical barrier-framed messages were also directly associated with an increased likelihood of signing up for a clinical trial (β=-.08, P=.03). The model accounted for 21% of the variance in clinical trial sign-up behavior. Attitude did not significantly affect behavioral intention in this study (β=.08, P=.14), and psychological and logistical barrier-framed messages did not significantly differ in attitudes toward clinical trial participation (β=-.04, P=.09). These findings advance our understanding of how people process popular message characteristics in short-form videos and lend practical guidance for communicators. We encourage medical professionals to consider short-form video sites (eg, TikTok and Instagram Reels) as effective tools for discussing clinical trials and participation opportunities. Specifically, featuring doctors discussing efforts to reduce logistical barriers is recommended. Our measuring of actual behavior as an outcome is a rare and noteworthy contribution to this research.

Real-life experience of canadian patients with homozygous familial hypercholesterolemia following nine years of participation in evinacumab clinical trials: The Canada ELIPSE-OLE study

Real-life experience of canadian patients with homozygous familial hypercholesterolemia following nine years of participation in evinacumab clinical trials: The Canada ELIPSE-OLE study

Acceptance of a third COVID-19 vaccine dose, vaccine interchangeability, and clinical trial enrolment among parents of children 12-17 years in Lima, Perú.

To characterize factors associated with parental willingness for their children participation in a COVID-19 vaccine trial, use of different COVID-19 vaccines and acceptance of a third vaccine dose. Parents of children aged 12-17 years in Lima, Perú were asked to complete an online questionnaire via social networks, from November 9, 2021, to April 23, 2022. We calculated crude and adjusted prevalence ratios with 95% confidence intervals to compare factors with the mentioned outcomes. From 523 parents responding, 374 completed the survey. 90.4% would give their children a third vaccine dose, 36.6% would allow their children participation in a COVID-19 vaccine clinical trial, and 33.2% would accept different vaccine brands between doses. Parental belief that COVID-19 vaccine studies met quality standards was associated with acceptance of a third booster dose (adjusted PR 3.25; 95% CI1.57-6.74; p = 0.002), enrolment in a COVID-19 clinical trial (adjusted PR 4.49; 95% CI1.25-16.06; p = 0.02), and acceptance of different COVID-19 vaccine brands between doses (adjusted PR 10.02; 95% CI1.40-71.95; p = 0.02). Most parents would accept a third vaccine booster dose, approximately a third would participate in COVID-19 vaccine trials. Believing COVID-19 vaccines studies fulfilled quality standards was associated with the study outcomes. It is necessary to inform about the rigorous processes for the development of COVID-19 vaccines to generate confidence in parents to accept these vaccine-related outcomes.