Pub Date : 2025-10-12DOI: 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.
{"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":"2025-10-12","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}
Pub Date : 2025-10-11DOI: 10.1016/j.conctc.2025.101559
Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort
Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.
{"title":"Protocol for the rural engagement in TelemedTeam for options in obesity treatment solutions (RE-TOOL): Cluster randomized trial investigating team-based telemedicine in rural primary care","authors":"Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort","doi":"10.1016/j.conctc.2025.101559","DOIUrl":"10.1016/j.conctc.2025.101559","url":null,"abstract":"<div><div>Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101559"},"PeriodicalIF":1.4,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333356","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}
Pub Date : 2025-10-09DOI: 10.1016/j.conctc.2025.101557
Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge
<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit
{"title":"Efficacy and safety of Chinese medicine compound for the convalescent COVID-19 patients: Protocol of a multi-centered, randomized, double-blinded, placebo-controlled clinical trial","authors":"Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge","doi":"10.1016/j.conctc.2025.101557","DOIUrl":"10.1016/j.conctc.2025.101557","url":null,"abstract":"<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101557"},"PeriodicalIF":1.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333355","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}
Pub Date : 2025-10-08DOI: 10.1016/j.conctc.2025.101558
Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise
Background
Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).
Objective
This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.
Study design
This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.
Main outcome measures
Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.1,2
Conclusion
We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.
{"title":"RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial","authors":"Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise","doi":"10.1016/j.conctc.2025.101558","DOIUrl":"10.1016/j.conctc.2025.101558","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).</div></div><div><h3>Objective</h3><div>This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.</div></div><div><h3>Study design</h3><div>This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.</div></div><div><h3>Main outcome measures</h3><div>Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.<sup>1,2</sup></div></div><div><h3>Conclusion</h3><div>We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.</div></div><div><h3>Trial Registration Number</h3><div>NCT06768099 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101558"},"PeriodicalIF":1.4,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333354","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}
Pub Date : 2025-10-03DOI: 10.1016/j.conctc.2025.101556
Sophie S. Hall , Evgenia Riga , Eleanor J. Mitchell , Louise Thomson , Jodi Taylor , Lucy Carr , Pamela Hagan , Kirsty Sprange
Background
Evaluating healthcare interventions in clinical trials requires a skilled workforce. However, the demands of developing and running clinical trials make recruiting and retaining staff challenging. Flourishing, which focuses on positive aspects of well-being, may help staff manage these demands. This study introduces the Flourishing As Clinical Trial Staff (FACTS) guidance, offering practical strategies to support staff working in UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs), to thrive at work.
Methods
Building upon findings from a national survey of staff working in UKCRC CTUs, a three-phase consensus-based approach was used to develop recommendations to support flourishing in clinical trial staff; (1) focus groups with staff (n = 24), (2) a consensus survey (n = 21) and (3) a consensus workshop (n = 15).
Results
The focus groups identified strategies for supporting CTU staff to flourish, including factors relating to the environment (e.g., flexible working); interpersonal communication (e.g., supportive colleagues), growth (e.g., protected training time) and acknowledgement of everyone's contributions. These strategies were developed into 67 wellbeing recommendations which were further evaluated in a consensus survey and workshop. Following this, 61 recommendations were endorsed for inclusion in the guidance.
Conclusions
The FACTS guidance includes recommendations to support UKCRC CTU staff to flourish in their work and are likely to apply more broadly to research institutions conducting clinical trials. The recommendations provide a foundation for CTUs to review and adapt to their local needs over time. Implementing these recommendations may prove beneficial for increasing job satisfaction and commitment, which is likely to facilitate efficient trial delivery.
{"title":"Wellbeing for staff in UKCRC-registered Clinical Trials Units: Development of the Flourishing As Clinical Trial Staff (FACTS) guidance: a mixed-methods study","authors":"Sophie S. Hall , Evgenia Riga , Eleanor J. Mitchell , Louise Thomson , Jodi Taylor , Lucy Carr , Pamela Hagan , Kirsty Sprange","doi":"10.1016/j.conctc.2025.101556","DOIUrl":"10.1016/j.conctc.2025.101556","url":null,"abstract":"<div><h3>Background</h3><div>Evaluating healthcare interventions in clinical trials requires a skilled workforce. However, the demands of developing and running clinical trials make recruiting and retaining staff challenging. Flourishing, which focuses on positive aspects of well-being, may help staff manage these demands. This study introduces the Flourishing As Clinical Trial Staff (FACTS) guidance, offering practical strategies to support staff working in UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs), to thrive at work.</div></div><div><h3>Methods</h3><div>Building upon findings from a national survey of staff working in UKCRC CTUs, a three-phase consensus-based approach was used to develop recommendations to support flourishing in clinical trial staff; (1) focus groups with staff (n = 24), (2) a consensus survey (n = 21) and (3) a consensus workshop (n = 15).</div></div><div><h3>Results</h3><div>The focus groups identified strategies for supporting CTU staff to flourish, including factors relating to the <em>environment</em> (e.g., flexible working)<em>; interpersonal communication</em> (e.g., supportive colleagues), <em>growth</em> (e.g., protected training time) and <em>acknowledgement</em> of everyone's contributions. These strategies were developed into 67 wellbeing recommendations which were further evaluated in a consensus survey and workshop. Following this, 61 recommendations were endorsed for inclusion in the guidance.</div></div><div><h3>Conclusions</h3><div>The FACTS guidance includes recommendations to support UKCRC CTU staff to flourish in their work and are likely to apply more broadly to research institutions conducting clinical trials. The recommendations provide a foundation for CTUs to review and adapt to their local needs over time. Implementing these recommendations may prove beneficial for increasing job satisfaction and commitment, which is likely to facilitate efficient trial delivery.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101556"},"PeriodicalIF":1.4,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268552","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}
Pub Date : 2025-09-20DOI: 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.
{"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":"2025-09-20","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}
Pub Date : 2025-09-16DOI: 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).
{"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":"2025-09-16","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}
Pub Date : 2025-09-16DOI: 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.
{"title":"Unmasking three blinding indices for randomized controlled trials: comparison and application","authors":"Javier Muñoz Laguna , Jafar Kolahi , Heejung Bang","doi":"10.1016/j.conctc.2025.101553","DOIUrl":"10.1016/j.conctc.2025.101553","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101553"},"PeriodicalIF":1.4,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268553","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}
Pub Date : 2025-09-16DOI: 10.1016/j.conctc.2025.101555
Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino
Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.
{"title":"Efficacy of an integrated treatment for fathers with Co-occurring substance misuse and family violence","authors":"Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino","doi":"10.1016/j.conctc.2025.101555","DOIUrl":"10.1016/j.conctc.2025.101555","url":null,"abstract":"<div><div>Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101555"},"PeriodicalIF":1.4,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108168","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}
Pub Date : 2025-09-10DOI: 10.1016/j.conctc.2025.101549
Ian H. Stanley , Julia Finn , Kathleen M. Flarity , Mengli Xiao , Rachel L. Johnson , Jaclyn C. Kearns , Natalie L. Wilver , Steven J. Berkowitz , Michael D. Anestis , Marian E. Betz , Joseph A. Simonetti
Firearm injury is the most common suicide method. When firearms are stored in a non-secure manner (e.g., unlocked, loaded), risk for suicide may be elevated. Accordingly, clinical, public health, and firearm industry stakeholders recommend efforts to promote secure firearm storage, such as lethal means safety counseling (LMSC). One LMSC intervention, Project Safe Guard (PSG), has demonstrated efficacy in prompting use of firearm locking devices in a sample of military service members; however, subsequent analyses show that PSG has diminished efficacy for individuals with elevated symptoms of posttraumatic stress disorder (PTSD). PTSD, characterized in part by hypervigilance to threat, is associated with elevated suicide risk as well as a greater likelihood of storing firearms using less secure methods. In response, our group developed an adaptation of PSG, termed Project Safe Guard-Trauma (PSG-T). This paper describes the design, methodology, and protocol of a randomized controlled trial comparing PSG-T to PSG among adults who screen positive for PTSD related to a victimization trauma (e.g., physical assault, sexual assault, combat) and who do not currently store all their personally owned firearms in a secure manner. PSG and PSG-T will be delivered by licensed clinical psychologists. Assessments will occur at pre-intervention, post-intervention, and 1-, 3-, and 6-month follow-up. The primary objective is to determine the efficacy of PSG-T in prompting greater beliefs and practices regarding secure storage of personal firearms.
{"title":"Project Safe Guard–Trauma (PSG-T): Protocol for a randomized controlled trial of lethal means safety counseling to promote secure firearm storage among individuals with PTSD","authors":"Ian H. Stanley , Julia Finn , Kathleen M. Flarity , Mengli Xiao , Rachel L. Johnson , Jaclyn C. Kearns , Natalie L. Wilver , Steven J. Berkowitz , Michael D. Anestis , Marian E. Betz , Joseph A. Simonetti","doi":"10.1016/j.conctc.2025.101549","DOIUrl":"10.1016/j.conctc.2025.101549","url":null,"abstract":"<div><div>Firearm injury is the most common suicide method. When firearms are stored in a non-secure manner (e.g., unlocked, loaded), risk for suicide may be elevated. Accordingly, clinical, public health, and firearm industry stakeholders recommend efforts to promote secure firearm storage, such as lethal means safety counseling (LMSC). One LMSC intervention, Project Safe Guard (PSG), has demonstrated efficacy in prompting use of firearm locking devices in a sample of military service members; however, subsequent analyses show that PSG has diminished efficacy for individuals with elevated symptoms of posttraumatic stress disorder (PTSD). PTSD, characterized in part by hypervigilance to threat, is associated with elevated suicide risk as well as a greater likelihood of storing firearms using less secure methods. In response, our group developed an adaptation of PSG, termed Project Safe Guard-Trauma (PSG-T). This paper describes the design, methodology, and protocol of a randomized controlled trial comparing PSG-T to PSG among adults who screen positive for PTSD related to a victimization trauma (e.g., physical assault, sexual assault, combat) and who do not currently store all their personally owned firearms in a secure manner. PSG and PSG-T will be delivered by licensed clinical psychologists. Assessments will occur at pre-intervention, post-intervention, and 1-, 3-, and 6-month follow-up. The primary objective is to determine the efficacy of PSG-T in prompting greater beliefs and practices regarding secure storage of personal firearms.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101549"},"PeriodicalIF":1.4,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145048841","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}
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