Contemporary Clinical Trials Communications最新文献_第5页

Frontier sites in clinical trials: Opportunities, challenges, and models 临床试验的前沿地点：机遇、挑战和模式

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-11-25 DOI: 10.1016/j.conctc.2025.101581

Andrea Bastek , Amanda Zenere , Heather Manley , Camille Finkle , Chad Jaeger , Janet Matthews , Kristie Moffett , Megan Solomon , Paula Underhill

Background

The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was established to explore the potential of non-traditional research sites—termed "frontier sites"—to address these issues by expanding access to underserved populations and embedding clinical research in community settings.

Methods

The task force defined frontier sites and conducted a survey to gather perspectives on their benefits, challenges, and support needs. Twenty-nine valid survey responses were collected. Respondents self-identified as having direct experience with frontier sites (“experienced respondents”) or answered based on their perception of working with frontier sites (“perception respondents”). Free-text responses were coded into categories and analyzed qualitatively and quantitatively.

Results

Access to new participant populations was the most cited benefit, and experienced respondents noted additional gains in site engagement and education. Operational infrastructure deficiencies were the primary challenge identified by both experienced and perception respondents. Experienced respondents highlighted greater concerns about compliance and community resistance. The primary support need identified was enhanced operational support and quality oversight. Differences between experienced and perception respondent groups suggested the need for broader industry education.

Conclusion

Frontier sites offer significant promise for increasing research capacity and diversity, but require substantial operational, educational, and community engagement support. These survey findings provide a foundation for shared understanding across the industry. From that foundation the industry can work to develop a playbook to guide the successful integration of frontier sites into clinical trial operations.

临床试验行业面临着越来越大的能力缺口，原因是研究数量不断增加，加上场地和人员短缺。前沿站点启用联盟（SEL）工作组的成立是为了探索非传统研究站点（称为“前沿站点”）的潜力，通过扩大对服务不足人群的访问和在社区环境中嵌入临床研究来解决这些问题。方法工作组确定了前沿站点，并进行了一项调查，以收集对其利益、挑战和支持需求的看法。收集了29份有效的调查回复。受访者自我认定有直接的边境工作经验（“有经验的受访者”），或根据他们对边境工作的感知来回答（“感知受访者”）。对自由文本回复进行分类，并进行定性和定量分析。结果获得新的参与者群体是被引用最多的好处，有经验的受访者注意到在现场参与和教育方面的额外收益。运营基础设施不足是经验丰富的受访者和有经验的受访者都认为的主要挑战。经验丰富的受访者强调了对合规性和社区阻力的更大担忧。确定的主要支助需要是加强业务支助和质量监督。有经验的受访者和有经验的受访者之间的差异表明，需要进行更广泛的行业教育。前沿站点为提高研究能力和多样性提供了巨大的希望，但需要大量的运营、教育和社区参与支持。这些调查结果为整个行业的共识提供了基础。在此基础上，该行业可以制定一份指南，指导将前沿站点成功整合到临床试验操作中。

{"title":"Frontier sites in clinical trials: Opportunities, challenges, and models","authors":"Andrea Bastek , Amanda Zenere , Heather Manley , Camille Finkle , Chad Jaeger , Janet Matthews , Kristie Moffett , Megan Solomon , Paula Underhill","doi":"10.1016/j.conctc.2025.101581","DOIUrl":"10.1016/j.conctc.2025.101581","url":null,"abstract":"<div><h3>Background</h3><div>The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was established to explore the potential of non-traditional research sites—termed \"frontier sites\"—to address these issues by expanding access to underserved populations and embedding clinical research in community settings.</div></div><div><h3>Methods</h3><div>The task force defined frontier sites and conducted a survey to gather perspectives on their benefits, challenges, and support needs. Twenty-nine valid survey responses were collected. Respondents self-identified as having direct experience with frontier sites (“experienced respondents”) or answered based on their perception of working with frontier sites (“perception respondents”). Free-text responses were coded into categories and analyzed qualitatively and quantitatively.</div></div><div><h3>Results</h3><div>Access to new participant populations was the most cited benefit, and experienced respondents noted additional gains in site engagement and education. Operational infrastructure deficiencies were the primary challenge identified by both experienced and perception respondents. Experienced respondents highlighted greater concerns about compliance and community resistance. The primary support need identified was enhanced operational support and quality oversight. Differences between experienced and perception respondent groups suggested the need for broader industry education.</div></div><div><h3>Conclusion</h3><div>Frontier sites offer significant promise for increasing research capacity and diversity, but require substantial operational, educational, and community engagement support. These survey findings provide a foundation for shared understanding across the industry. From that foundation the industry can work to develop a playbook to guide the successful integration of frontier sites into clinical trial operations.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101581"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Establishing a clinical trial site: A primer for aspiring principal investigators 建立临床试验地点：有抱负的主要研究者的入门书

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-10-12 DOI: 10.1016/j.conctc.2025.101561

John J. Sramek, Modesto S. Carrillo, Neal R. Cutler

Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching and operating a successful site.

The topics covered include regulatory responsibilities, financial considerations, infrastructure needs, staffing roles, investigational product handling, standard operating procedures, IRB oversight, informed consent, and patient recruitment and retention strategies. Special emphasis is placed on compliance with FDA regulations and Good Clinical Practice (GCP) standards, ensuring data integrity and the protection of study participants.

The paper highlights the importance of robust infrastructure—from calibrated laboratory equipment and secure drug storage to electronic data capture systems—and the need for well-trained support staff, including clinical research coordinators and sub-investigators. The recruitment and retention of diverse participants is explored through ethical, patient-centered engagement strategies. Additionally, guidance is provided on navigating site feasibility assessments, sponsor negotiations, and the startup study process.

Drawing from the authors’ experience establishing clinical trial sites and contract research organizations, this guide offers strategic insights on building sponsor relationships, evaluating protocol feasibility, and enhancing site performance metrics. The evolving clinical trial landscape—driven by new therapeutic developments and digital technologies—demands that PIs not only meet regulatory standards but also demonstrate leadership, operational excellence, and a commitment to scientific integrity.

对于有兴趣成为fda监管研究的首席研究员（pi）的医生来说，建立一个私人临床试验地点是一个越来越有吸引力但复杂的机会。本文为有抱负的pi提供了全面的概述，详细介绍了启动和运营成功站点的关键需求和最佳实践。涵盖的主题包括监管责任、财务考虑、基础设施需求、人员角色、研究产品处理、标准操作程序、内部审查委员会监督、知情同意以及患者招募和保留策略。特别强调遵守FDA法规和良好临床实践（GCP）标准，确保数据完整性和对研究参与者的保护。该论文强调了强大的基础设施的重要性——从校准的实验室设备和安全的药物储存到电子数据捕获系统——以及对训练有素的支持人员的需求，包括临床研究协调员和副研究员。通过道德的、以患者为中心的参与策略来探索不同参与者的招募和保留。此外，还提供了导航站点可行性评估，赞助商谈判和启动研究过程的指导。根据作者建立临床试验点和合同研究组织的经验，本指南提供了建立赞助商关系、评估方案可行性和增强站点性能指标的战略见解。在新的治疗发展和数字技术的推动下，不断发展的临床试验领域要求pi不仅要满足监管标准，还要表现出领导力、卓越的运营能力和对科学诚信的承诺。

{"title":"Establishing a clinical trial site: A primer for aspiring principal investigators","authors":"John J. Sramek, Modesto S. Carrillo, Neal R. Cutler","doi":"10.1016/j.conctc.2025.101561","DOIUrl":"10.1016/j.conctc.2025.101561","url":null,"abstract":"<div><div>Establishing a private clinical trial site is an increasingly appealing but complex opportunity for physicians interested in becoming Principal Investigators (PIs) in FDA-regulated research. This article provides a comprehensive overview for aspiring PIs, detailing the critical requirements and best practices for launching and operating a successful site.</div><div>The topics covered include regulatory responsibilities, financial considerations, infrastructure needs, staffing roles, investigational product handling, standard operating procedures, IRB oversight, informed consent, and patient recruitment and retention strategies. Special emphasis is placed on compliance with FDA regulations and Good Clinical Practice (GCP) standards, ensuring data integrity and the protection of study participants.</div><div>The paper highlights the importance of robust infrastructure—from calibrated laboratory equipment and secure drug storage to electronic data capture systems—and the need for well-trained support staff, including clinical research coordinators and sub-investigators. The recruitment and retention of diverse participants is explored through ethical, patient-centered engagement strategies. Additionally, guidance is provided on navigating site feasibility assessments, sponsor negotiations, and the startup study process.</div><div>Drawing from the authors’ experience establishing clinical trial sites and contract research organizations, this guide offers strategic insights on building sponsor relationships, evaluating protocol feasibility, and enhancing site performance metrics. The evolving clinical trial landscape—driven by new therapeutic developments and digital technologies—demands that PIs not only meet regulatory standards but also demonstrate leadership, operational excellence, and a commitment to scientific integrity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101561"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial 前瞻性临床试验入组改善试验内混合研究的基本原理和方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-09-20 DOI: 10.1016/j.conctc.2025.101548

Patrick Lewicki , Sabrina Clark , Elaina Shoemaker , Bingkai Wang , Jerison Ross , Stephanie Daignault-Newton , Noelle Carlozzi , Adam Martin-Schwarze , William Meurer , Anne Sales , Khurshid Ghani , Casey Dauw , Kristian Stensland

Introduction

Enrollment to clinical trials is challenging, and few evidence-based interventions to improve enrollment exist. Provider-facing advertising campaigns could help increase enrollment, but this type of intervention has not been prospectively evaluated in a clinical trial.

Methods

We designed a randomized clinical trial to evaluate the effect of a month-long email advertising campaign on enrollment to a clinical trial. This hybrid implementation-effectiveness Study Within a Trial tested the effect of precision audit and feedback techniques enrollment effectiveness outcomes (enrollment) and measured implementation outcomes (email opens, link clicks). This design is an application of a Study Within a Trial (SWAT) to evaluate an intervention intended to improve enrollment. The goal of this study was to inform both this advertising campaign and refine SWAT methods for evaluating future trial improvement interventions.

Discussion

This Study Within a Trial provides preliminary data on the effectiveness of email advertising campaigns for improving clinical trial enrollment. Additionally, the infrastructure built through this SWAT will inform future studies of clinical trial enrollment improvement. This protocol can serve as a template for other investigators seeking to evaluate enrollment improvement interventions.

临床试验的入组具有挑战性，并且很少有基于证据的干预措施来改善入组。面向医疗服务提供者的广告活动可能有助于增加注册人数，但这种类型的干预尚未在临床试验中进行前瞻性评估。方法：我们设计了一项随机临床试验来评估为期一个月的电子邮件广告活动对临床试验报名的影响。这项混合实施-有效性的试验研究测试了精确审计和反馈技术的效果，登记有效性结果（登记）和测量实施结果（电子邮件打开，链接点击）。本设计是一项试验中研究（SWAT）的应用，旨在评估旨在提高入组率的干预措施。本研究的目的是为广告宣传和改进SWAT方法提供信息，以评估未来的试验改进干预措施。本试验研究为电子邮件广告活动对提高临床试验入组率的有效性提供了初步数据。此外，通过SWAT建立的基础设施将为临床试验注册改进的未来研究提供信息。该方案可以作为其他研究者寻求评估入组改善干预措施的模板。

{"title":"Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial","authors":"Patrick Lewicki , Sabrina Clark , Elaina Shoemaker , Bingkai Wang , Jerison Ross , Stephanie Daignault-Newton , Noelle Carlozzi , Adam Martin-Schwarze , William Meurer , Anne Sales , Khurshid Ghani , Casey Dauw , Kristian Stensland","doi":"10.1016/j.conctc.2025.101548","DOIUrl":"10.1016/j.conctc.2025.101548","url":null,"abstract":"<div><h3>Introduction</h3><div>Enrollment to clinical trials is challenging, and few evidence-based interventions to improve enrollment exist. Provider-facing advertising campaigns could help increase enrollment, but this type of intervention has not been prospectively evaluated in a clinical trial.</div></div><div><h3>Methods</h3><div>We designed a randomized clinical trial to evaluate the effect of a month-long email advertising campaign on enrollment to a clinical trial. This hybrid implementation-effectiveness Study Within a Trial tested the effect of precision audit and feedback techniques enrollment effectiveness outcomes (enrollment) and measured implementation outcomes (email opens, link clicks). This design is an application of a Study Within a Trial (SWAT) to evaluate an intervention intended to improve enrollment. The goal of this study was to inform both this advertising campaign and refine SWAT methods for evaluating future trial improvement interventions.</div></div><div><h3>Discussion</h3><div>This Study Within a Trial provides preliminary data on the effectiveness of email advertising campaigns for improving clinical trial enrollment. Additionally, the infrastructure built through this SWAT will inform future studies of clinical trial enrollment improvement. This protocol can serve as a template for other investigators seeking to evaluate enrollment improvement interventions.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101548"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145119444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial) 细菌性阴道病抗生素治疗后多菌种crispr乳杆菌阴道活生物治疗产品的随机试验：研究方案（阴道活生物治疗随机试验）

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-09-16 DOI: 10.1016/j.conctc.2025.101554

Callin Chetty , Nomfuneko Mafunda , Anna-Ursula Happel , Anam Khan , Briah Cooley Demidkina , Nonhlanhla Yende-Zuma , Yusra Saidi , Asthu Mahabeer Polliah , Lara Lewis , Farzana Osman , Precious Radebe , Jo-Ann S. Passmore , Doug Kwon , Jacques Ravel , Sinaye Ngcapu , Lenine Liebenberg , Laura Symul , Susan Holmes , Caroline M. Mitchell , Disebo Potloane

Background

Globally, approximately 30 % of women have bacterial vaginosis (BV). Antibiotic treatment is frequently followed by recurrence, likely due to lack of colonization with beneficial lactobacilli.

Methods

This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish Lactobacillus colonization. The LBP are vaginal tablets containing 6 L. crispatus strains (LC106) or 15 L. crispatus strains (LC115), at 2 x 10⁹ colony forming units (CFU) per dose. Participants with BV in the United States and South Africa will receive seven days of oral metronidazole twice daily and will be randomized 1:1:1:1:1 to: seven days placebo; seven days LC106; three days LC106/four days placebo; seven days LC106 starting day 3 of the metronidazole course; or seven days LC115. Safety will be assessed by the number and percentage of ≥ Grade 2 related adverse events during or after product use. The primary outcome is LBP colonization defined as relative abundance ≥5 % of any LBP strain or ≥10 % of a combination of LBP strains by metagenomic sequencing any time in the 5 weeks after randomization. A generalized linear model will measure the association between treatment group and colonization, adjusting for site.

Conclusions

This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal L. crispatus colonization in two geographically distinct populations.

Trial registration

South African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 11, 2023).

Protocol version

2.0 dated October 03, 2023.

在全球范围内，大约30%的女性患有细菌性阴道病（BV）。抗生素治疗后经常复发，可能是由于缺乏有益的乳酸菌定植。方法：这是一项随机、安慰剂对照的i期临床试验，研究阴道活生物治疗产品（LBP）在抗生素治疗细菌性阴道炎后建立乳杆菌定植。LBP是阴道片剂，含有6株葡萄球菌（LC106）或15株葡萄球菌（LC115），每剂量2 × 109菌落形成单位（CFU）。美国和南非的BV患者将接受为期7天的甲硝唑口服治疗，每日两次，并将按1:1:1:1:1随机分配至：7天安慰剂；7天LC106；3天LC106/ 4天安慰剂；7天LC106，甲硝唑疗程第3天开始；或7天LC115。安全性将通过产品使用期间或使用后≥2级相关不良事件的数量和百分比进行评估。主要终点是LBP定殖，定义为随机分组后5周内任何时间任何LBP菌株的相对丰度≥5%或LBP菌株组合的相对丰度≥10%。一个广义的线性模型将测量治疗组和定植之间的关系，调整地点。结论本研究旨在建立多菌株LBP在两个地理上不同的人群中促进阴道crispatus定植的概念证明。试验注册：南非国家临床试验注册中心（SANCTR DOH-27-102023-8342； 2023年10月27日）和ClinicalTrials.gov （NCT06135974； 2023年11月11日）。协议版本2.0，日期为2023年10月3日。

{"title":"Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial)","authors":"Callin Chetty , Nomfuneko Mafunda , Anna-Ursula Happel , Anam Khan , Briah Cooley Demidkina , Nonhlanhla Yende-Zuma , Yusra Saidi , Asthu Mahabeer Polliah , Lara Lewis , Farzana Osman , Precious Radebe , Jo-Ann S. Passmore , Doug Kwon , Jacques Ravel , Sinaye Ngcapu , Lenine Liebenberg , Laura Symul , Susan Holmes , Caroline M. Mitchell , Disebo Potloane","doi":"10.1016/j.conctc.2025.101554","DOIUrl":"10.1016/j.conctc.2025.101554","url":null,"abstract":"<div><h3>Background</h3><div>Globally, approximately 30 % of women have bacterial vaginosis (BV). Antibiotic treatment is frequently followed by recurrence, likely due to lack of colonization with beneficial lactobacilli.</div></div><div><h3>Methods</h3><div>This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish <em>Lactobacillus</em> colonization. The LBP are vaginal tablets containing 6 <em>L. crispatus</em> strains (LC106) or 15 <em>L. crispatus</em> strains (LC115), at 2 x 10<sup>9</sup> colony forming units (CFU) per dose. Participants with BV in the United States and South Africa will receive seven days of oral metronidazole twice daily and will be randomized 1:1:1:1:1 to: seven days placebo; seven days LC106; three days LC106/four days placebo; seven days LC106 starting day 3 of the metronidazole course; or seven days LC115. Safety will be assessed by the number and percentage of ≥ Grade 2 related adverse events during or after product use. The primary outcome is LBP colonization defined as relative abundance ≥5 % of any LBP strain or ≥10 % of a combination of LBP strains by metagenomic sequencing any time in the 5 weeks after randomization. A generalized linear model will measure the association between treatment group and colonization, adjusting for site.</div></div><div><h3>Conclusions</h3><div>This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal <em>L. crispatus</em> colonization in two geographically distinct populations.</div></div><div><h3>Trial registration</h3><div>South African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 11, 2023).</div></div><div><h3>Protocol version</h3><div>2.0 dated October 03, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101554"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults 光生物调节治疗成人颞下颌紊乱性疼痛的随机对照试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-11-24 DOI: 10.1016/j.conctc.2025.101571

Selenia Rubio , Patricia Cabrera , Rory Reever , Cesar Migliorati , Richard Ohrbach , Frank C. Gibson III , Zhigang Li , Angela Mickle , Rosalynn R.Z. Conic , Roger B. Fillingim , Margarete Ribeiro Dasilva

Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response.

Clinicaltrials.gov identifier

NCT05916235

目前缺乏针对疼痛性颞下颌疾病（TMD）的循证治疗方法。对于疼痛的颞下颌关节痛，最常见的治疗方法，口腔内矫治器和止痛药，提供了次优的疼痛控制，往往导致治疗限制的不良反应。光生物调节疗法（PBM）显示出治疗TMD患者疼痛的巨大潜力；然而，其减轻TMD疼痛的功效尚未经过严格的测试。我们将进行一项双盲、随机、安慰剂对照的多模式PBM治疗TMD疼痛的临床试验。这项单点试验将随机抽取130名18岁及以上的慢性疼痛性TMD患者。个人将完成详细的病史以确认资格标准，然后根据TMD诊断标准（DC/TMD）进行临床检查以确认TMD病例状态。符合条件的参与者将随机接受积极或假PBM治疗。参与者将完成8次治疗访问，间隔2-5天。随后将进行干预后随访，包括症状问卷调查、TMD检查、压痛阈值（PPT）测量和抽血。6个月的随访将包括TMD检查、问卷调查和压力痛阈测量。分析将确定干预对主要结局（疼痛强度）和多个次要结局的影响，并将检查炎症和疼痛敏感性的变化是否与干预反应相关

{"title":"A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults","authors":"Selenia Rubio , Patricia Cabrera , Rory Reever , Cesar Migliorati , Richard Ohrbach , Frank C. Gibson III , Zhigang Li , Angela Mickle , Rosalynn R.Z. Conic , Roger B. Fillingim , Margarete Ribeiro Dasilva","doi":"10.1016/j.conctc.2025.101571","DOIUrl":"10.1016/j.conctc.2025.101571","url":null,"abstract":"<div><div>Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response.</div></div><div><h3>Clinicaltrials.gov identifier</h3><div>NCT05916235</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101571"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults SHINE项目（促进公平睡眠健康倡议）的研究方案：一项以社区为基础的试验随机对照试验，旨在促进黑人/非裔美国成年人的睡眠和体育活动

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-08-29 DOI: 10.1016/j.conctc.2025.101541

Ivan HC. Wu , Lorna McNeill , Kristen Knutson , Yisheng Li , Diwakar Balachandran , Rhonda Jones-Webb , Pamela L. Lutsey , Darin Erikson , Shikha Bista , Rachel Price , Vanessa Anyanso , Taylor Smith , Rev Melvin Miller

Background

Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.

Methods

This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.

Discussion

This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, Project SHINE aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.

背景：与白人相比，黑人/非裔美国人（AA）成年人的睡眠时间更短，睡眠质量更差，这导致他们患慢性病的风险更高。SHINE项目（Sleep Health INitiative for Equity，睡眠健康公平倡议）旨在通过评估一种文化量身定制的睡眠干预的可行性、满意度和合理性（即初步疗效）来解决这些睡眠差异，该干预旨在改善体重指数(BMI)≥25的AA级成人的睡眠时间和身体活动，这些成年人不符合身体活动和睡眠指南的建议。方法以社区为基础的随机对照试验（RCT）分为两个阶段。第一阶段包括对AA成人进行定性访谈，以探索与睡眠相关的社会背景因素，以完善干预措施。第二阶段是一项随机对照试验（n = 80），分配参与者进行为期四周的睡眠延长干预或接触控制。睡眠延长干预旨在改善睡眠时间和身体活动。会议通过Zoom进行，包括面对面的基线和后续访问。主要结局包括干预的可行性和满意度。次要结果包括自我报告和客观的睡眠和身体活动测量，以及癌症和心血管风险的探索性生物标志物。额外的自我报告评估睡眠相关的心理社会因素和健康行为。本研究将评估一种针对嗜酒者的虚拟睡眠干预的可行性和实施。通过整合行为改变理论、文化适应框架和社区参与原则，SHINE项目旨在为更大规模的试验提供信息，并支持可扩展的行为干预措施，以改善睡眠健康并减少差异。

{"title":"Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults","authors":"Ivan HC. Wu , Lorna McNeill , Kristen Knutson , Yisheng Li , Diwakar Balachandran , Rhonda Jones-Webb , Pamela L. Lutsey , Darin Erikson , Shikha Bista , Rachel Price , Vanessa Anyanso , Taylor Smith , Rev Melvin Miller","doi":"10.1016/j.conctc.2025.101541","DOIUrl":"10.1016/j.conctc.2025.101541","url":null,"abstract":"<div><h3>Background</h3><div>Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.</div></div><div><h3>Methods</h3><div>This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.</div></div><div><h3>Discussion</h3><div>This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, <em>Project SHINE</em> aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101541"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3 更新的监管指南对当代无并发症尿路感染临床试验研究结果的影响以及对试验进行和药物开发的影响：EAGLE-2和EAGLE-3的比较分析

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-11-18 DOI: 10.1016/j.conctc.2025.101572

Florian Wagenlehner , Keith S. Kaye , David A. Talan , Amanda J. Sheets , Nicole E. Scangarella-Oman , Emily Jarvis , Jeremy Dennison , Salim Janmohamed , Matthew Helgeson , Caroline Perry

Aim

To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.

Methods

EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥10⁵ colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.

Results

Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).

Conclusion

Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.

The trials are registered at Clinicaltrials.gov (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).

目的了解现行非劣效性随机对照试验（RCTs）对非复杂性尿路感染（uUTI）疗效结局的影响。方法seagle -2和EAGLE-3为临床3期非劣效性随机对照试验，对uUTI女性患者口服吉波替达素（1500mg，每日2次，连用5天）与呋喃妥因（100mg BID，连用5天）进行对照。复合（临床和微生物学）主要终点，治疗反应（成功或失败），在治愈试验（10-13天）对呋喃妥英敏感尿路病原体（≥105菌落形成单位/mL）的参与者进行评估。成功需要症状的解决和微生物的根除；缺少数据或额外使用抗菌药物被认为是失败的。EAGLE-2/ 3结果与历史呋喃妥因随机对照试验进行比较，探索性终点-症状“缓解或接近缓解”（仅剩下一种轻微症状）和研究者评估的临床反应(IACR) -被用作临床成功的替代指标。结果在不同终点的EAGLE-2/ 3组中，硝基呋喃妥英治疗成功率（47% / 44%）明显低于历史研究（61% - 94%）。基于症状“缓解或接近缓解”的临床成功率，吉波替达星/呋喃妥英分别为78.3% / 77.2% （EAGLE-2）和75.7% / 75.3% （EAGLE-3）。IACR率分别为84.5% / 82.6% （EAGLE-2）和75.5% / 76.4% (EAGLE-3)（事后分析）。结论：在比较当代和历史uUTI随机对照试验时，需要考虑主要终点成功标准的差异。这些试验已在Clinicaltrials.gov上注册（EAGLE-2, NCT04020341; EAGLE-3, NCT04187144）。

{"title":"Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3","authors":"Florian Wagenlehner , Keith S. Kaye , David A. Talan , Amanda J. Sheets , Nicole E. Scangarella-Oman , Emily Jarvis , Jeremy Dennison , Salim Janmohamed , Matthew Helgeson , Caroline Perry","doi":"10.1016/j.conctc.2025.101572","DOIUrl":"10.1016/j.conctc.2025.101572","url":null,"abstract":"<div><h3>Aim</h3><div>To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.</div></div><div><h3>Methods</h3><div>EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥10<sup>5</sup> colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.</div></div><div><h3>Results</h3><div>Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).</div></div><div><h3>Conclusion</h3><div>Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.</div><div>The trials are registered at <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101572"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Unmasking three blinding indices for randomized controlled trials: comparison and application 随机对照试验中三个盲指标的揭示：比较与应用

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-09-16 DOI: 10.1016/j.conctc.2025.101553

Javier Muñoz Laguna , Jafar Kolahi , Heejung Bang

Blinding is an important methodological aspect of randomized controlled trials. Although three blinding indices are available for the estimation of blinding in clinical trials, little guidance is available regarding their comparison and application. Here, we compared three blinding indices and applied them to hypothetical and real-world clinical trial data. Through this comparison and application tutorial, we identified strengths and limitations of each blinding index. Our findings provide insights into the assessment, estimation and reporting of blinding in randomized controlled trials.

盲法是随机对照试验的一个重要方法学方面。在临床试验中，虽然有三个盲化指标可用于盲化的估计，但在它们的比较和应用方面却缺乏指导。在这里，我们比较了三个盲法指标，并将它们应用于假设的和现实世界的临床试验数据。通过这个比较和应用教程，我们确定了每个盲化指标的优势和局限性。我们的研究结果为随机对照试验中盲法的评估、估计和报告提供了见解。

引用次数: 0

Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease VICTRIVA研究的设计和基本原理：vedolizumab联合upadacitinib治疗克罗恩病的随机、双盲、3b期研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-11-24 DOI: 10.1016/j.conctc.2025.101574

Silvio Danese , Bruce E. Sands , Brian G. Feagan , Vipul Jairath , Remo Panaccione , Laurent Peyrin-Biroulet , Peter M. Irving , Stefan Schreiber , Iris Dotan , Marc Ferrante , Geert R. D'Haens , Stephen Jones , Marcelo Freire , Dirk Lindner , Shashi Adsul , Pooja Oberai , Jean-Frédéric Colombel

Introduction

Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.

Methods

The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.

Conclusion

VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.

Clinical trials registration

ClinicalTrials.gov, NCT06227910.

克罗恩病（CD）患者的缓解率表明一种高级靶向治疗的治疗上限，这代表了一种未满足的需求。双重靶向治疗可能提供更有效的治疗方法。VICTRIVA （NCT06227910）是一项随机、双盲、3b期临床试验，在有生物学经验的biologic-naïve成年CD患者中进行，主要目的是评估vedolizumab联合upadacitinib诱导是否在第12周(W)时比单独使用vedolizumab提高临床缓解率和内镜下反应率。患者将以1:1的比例随机分配至维多单抗（300 mg, W0, W2， W6和W10）和更新他替尼45 mg或安慰剂每日。W12应答者将进入维持组直至W52 （vedolizumab单药治疗每8周[Q8W]从W14至W52；如果需要Q4W升级）。尽管剂量增加，但在维持治疗期间失去反应的患者将进入拯救亚研究（vedolizumab Q4W + upadacitinib 45mg，持续12周，然后对恢复反应的患者进行vedolizumab单药治疗）。评估包括患者报告的结果（PROs）、CD活动指数（CDAI）和简单内镜下CD评分（SES-CD）。在全球范围内，将招募396名患者（每组198名）。其中，最少50%和最多50%将是biologic-naïve。共同主要终点是W12时CDAI临床缓解和SES-CD内镜下反应。关键次要终点包括W12时PRO2临床缓解、CDAI临床缓解、SES-CD内窥镜反应和W52时PRO2临床缓解。安全性终点包括治疗中出现的不良事件的发生率。结论victriva将评估vedolizumab联合upadacitinib诱导治疗相对于vedolizumab单药治疗的有效性和安全性，旨在打破目前的治疗天花板。临床试验注册：clinicaltrials .gov, NCT06227910。

{"title":"Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease","authors":"Silvio Danese , Bruce E. Sands , Brian G. Feagan , Vipul Jairath , Remo Panaccione , Laurent Peyrin-Biroulet , Peter M. Irving , Stefan Schreiber , Iris Dotan , Marc Ferrante , Geert R. D'Haens , Stephen Jones , Marcelo Freire , Dirk Lindner , Shashi Adsul , Pooja Oberai , Jean-Frédéric Colombel","doi":"10.1016/j.conctc.2025.101574","DOIUrl":"10.1016/j.conctc.2025.101574","url":null,"abstract":"<div><h3>Introduction</h3><div>Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.</div></div><div><h3>Methods</h3><div>The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.</div></div><div><h3>Conclusion</h3><div>VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.</div></div><div><h3>Clinical trials registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT06227910.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101574"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study 评估最近有自杀倾向的退伍军人的持续身份认知疗法：一项开放标签小组试点研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 Epub Date: 2025-11-24 DOI: 10.1016/j.conctc.2025.101576

Yosef Sokol , Sofie Glatt , Sarah Andrusier , Chynna Levin , Caroline Boucher , Josephine Ridley , Clayton H. Brown , Yulia Landa , Shirley Glynn , Marianne Goodman

Introduction

There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.

Method

Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.

Results

CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.

Discussion

The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.

Clinical trial registration

NCT04731519.

对于经历过自杀想法和/或行为的退伍军人，特别是那些从自杀事件中恢复过来的退伍军人，有效的康复导向治疗存在差距。本研究旨在评估持续身份认知疗法（CI-CT）的可行性和可接受性，并通过迭代开发过程来完善其干预措施。CI-CT是一种面向近期有自杀倾向的退伍军人的新型康复导向心理治疗方法。CI-CT在认知治疗框架内整合了个人同一性和自我的理论。它旨在通过构建一个连贯的、有意义的自我叙述来修复个人身份，将现在与一个清晰、详细、现实和期望的未来自我联系起来。方法采用CI-CT单臂试验，评价其治疗的可行性和可接受性。试验是迭代进行的，每次试验都结合了前一次试验的经验教训和修改。参与者（N = 15名同意，N = 12名开始治疗，11名完成完整干预）是在过去两年内有自杀企图或自杀计划的美国退伍军人。结果从招募率、出勤率、低辍学率、高随访评估完成率和参与者反馈来看，sci - ct具有较高的可行性和可接受性。此外，有高水平的测量客户满意度和积极的定性反馈。高出勤率和保留率以及积极的退伍军人反馈支持在随机临床试验中进一步探索和测试CI-CT。临床试验注册号nct04731519。

{"title":"Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study","authors":"Yosef Sokol , Sofie Glatt , Sarah Andrusier , Chynna Levin , Caroline Boucher , Josephine Ridley , Clayton H. Brown , Yulia Landa , Shirley Glynn , Marianne Goodman","doi":"10.1016/j.conctc.2025.101576","DOIUrl":"10.1016/j.conctc.2025.101576","url":null,"abstract":"<div><h3>Introduction</h3><div>There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.</div></div><div><h3>Method</h3><div>Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.</div></div><div><h3>Results</h3><div>CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.</div></div><div><h3>Discussion</h3><div>The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.</div></div><div><h3>Clinical trial registration</h3><div>NCT04731519.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101576"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0