Contemporary Clinical Trials Communications最新文献

{"title":"Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations","authors":"Huynh-Nhu Le ,&nbsp;Nickie Andescavage ,&nbsp;Jennifer M. Keller ,&nbsp;Maariya M. Bassa ,&nbsp;Aimee L. Danielson ,&nbsp;Diedtra Henderson ,&nbsp;Shanae Bond ,&nbsp;Nandi Mjenga ,&nbsp;Stephanie Wells ,&nbsp;Patricia Quinn ,&nbsp;Catherine Limperopoulos","doi":"10.1016/j.conctc.2025.101489","DOIUrl":"10.1016/j.conctc.2025.101489","url":null,"abstract":"<div><h3>Background</h3><div>Mental health disorders, including stress, anxiety, and depression, are the most common complications during pregnancy, with significant racial disparities in prevalence and access to care. Low-income Black/African American/of African descent (Black) individuals are at greater risk for perinatal mental health issues and face more obstacles to care due to a variety of barriers, including poor implementation of screening protocols, stigma, adverse experiences of social determinants of health, and distrust of healthcare systems. These disparities are particularly striking in Washington, DC, and worsened during the COVID-19 pandemic.</div></div><div><h3>Methods</h3><div>This study has two aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) prevention and treatment intervention for low-income Black pregnant women; and (2) to determine the effectiveness of multiple interventions: patient navigation, culturally adapted CBT, and/or peer support groups versus usual care for pregnant individuals at subthreshold and threshold risk for prenatal stress, depression and/or anxiety in a two-arm prospective longitudinal randomized controlled study. Outcomes will be tracked from pregnancy through 12 months postpartum, assessing maternal mental health, engagement with the intervention, healthcare experiences and utilization, and infant outcomes.</div></div><div><h3>Conclusions</h3><div>If found to be efficacious, results will help develop scalable, culturally relevant interventions aimed at reducing racial disparities in maternal mental health care and improving health outcomes for both mothers and infants. Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID NCT05345834.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101489"},"PeriodicalIF":1.4,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143876715","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}

{"title":"Protocol of Brief Behavioral Treatment for insomnia intervention for adult patients with cancer and their sleep-partner caregivers","authors":"Youngmee Kim ,&nbsp;Thomas C. Tsai ,&nbsp;Wendy M. Troxel","doi":"10.1016/j.conctc.2025.101486","DOIUrl":"10.1016/j.conctc.2025.101486","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbance is common and problematic among both patients with cancer and their sleep-partner caregivers. Although one's sleep affects the partner's sleep, existing psychobehavioral interventions have targeted patients' and caregivers' sleep problems independently.</div></div><div><h3>Methods</h3><div>We adapt the Brief Behavioral Treatment for Insomnia (BBTI) for both adult patients and their sleep-partner caregivers in the context of cancer. This protocol is to test the feasibility and acceptability as well as to provide preliminary efficacy of the BBTI for Couples with Cancer (BBTI-CC) intervention, which is to reduce sleep disturbance and improving sleep quality of both adults with cancer and their sleep-partner caregivers. The intervention will be delivered weekly for 4 weeks. Questionnaire and daily sleep logs will be collected at baseline (T1) and one-week after conclusion of the intervention (T2). Satisfaction with the intervention will be assessed weekly for 4 weeks.</div></div><div><h3>Results</h3><div>We estimate 18 dyads will be enrolled (18 patients and 18 caregivers). We expect &gt;75 % of eligible and screened dyads will enroll within the enrollment period, &gt;80 % of enrolled dyads will complete the intervention, and &gt;80 % of participants will report satisfaction across all acceptability measures. We also expect BBTI-CC will reveal a small-to-medium effect on sleep efficiency (primary outcome), overall sleep disturbance, subjective sleep quality, and insomnia severity (secondary outcomes).</div></div><div><h3>Conclusions</h3><div>Results will inform the feasibility and acceptability of conducting a dyadic sleep behavioral intervention, and provide preliminary efficacy data to guide further refinement of intervention content and procedure for adult patients with cancer and their sleep-partner caregivers.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101486"},"PeriodicalIF":1.4,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143852341","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}

{"title":"Design and refinement of a clinical trial staffing model within the evolving landscape of oncology clinical trials","authors":"Ellen Siglinsky,&nbsp;Hannah Phan,&nbsp;Silviya Meletath,&nbsp;Amber Neal,&nbsp;David E. Gerber,&nbsp;Asal Rahimi,&nbsp;Erin L. Williams","doi":"10.1016/j.conctc.2025.101485","DOIUrl":"10.1016/j.conctc.2025.101485","url":null,"abstract":"<div><h3>Background</h3><div>Quantifying workload for clinical trial staff represents an ongoing challenge for healthcare facilities conducting cancer clinical trials. We developed and evaluated a staffing model designed to meet this need.</div></div><div><h3>Methods</h3><div>To address individual protocol acuity, the model's algorithms include metrics to account for visit frequency, and the quantity, and types of research-related procedures. Since implementation in 2012, the model has been used to justify clinical research team resource needs and to establish metrics for leadership to reference when reviewing replacement positions; particularly useful to justify resources at the institutional level during the COVID-19 pandemic.</div><div>In recent years, we identified a gap between predicted and actual staff workload. This precipitated a comprehensive review in 2021 of all aspects of scoring within the model including a comparison to modern protocols to ensure accounting for all types of protocol-related procedures and tests.</div></div><div><h3>Results</h3><div>Further investigation identified increasing complexity of trial screening, which had not been accounted for in the initial model. Specifically, screening-related activities accounted for up to 25% of coordinator effort. We incorporated this work into the model and demonstrated a statistically significant change in average protocol acuity (<em>P</em> = 0.002) following refinement of scoring to include study-specific screening complexity.</div></div><div><h3>Conclusion</h3><div>Over the past decade, cancer clinical trial screening has increased in complexity and duration. Planning a cancer center's clinical trial workforce requires consideration of screening-related staff effort. For any effort model to be successful, ongoing examination and malleability are critical in this evolving landscape of clinical trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101485"},"PeriodicalIF":1.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143870580","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}

{"title":"Study protocol: Apps and peer support for a healthy future and living well with diabetes (APHLID-M)","authors":"K.O. Mathews ,&nbsp;F. MacMillan ,&nbsp;V. Wong ,&nbsp;M. Craig ,&nbsp;J.R. Greenfield ,&nbsp;R. Hicks ,&nbsp;T. Jones ,&nbsp;A. Poynten ,&nbsp;T. Wong ,&nbsp;M. Reyes ,&nbsp;K. Tannous ,&nbsp;C. Wilson ,&nbsp;P. Hay ,&nbsp;S. Abdo ,&nbsp;M.K. Piya ,&nbsp;J. Lai ,&nbsp;M. Venigalla ,&nbsp;R. Thomson ,&nbsp;D. Simmons","doi":"10.1016/j.conctc.2025.101484","DOIUrl":"10.1016/j.conctc.2025.101484","url":null,"abstract":"<div><h3>Background</h3><div>Mental health conditions are common among non-pregnant young people with any form of diabetes, affecting diabetes self-management and increasing complications risk. Limited evidence exists on whether smartphone applications “apps” combining diabetes and mental health (MH) support can improve self-management and MH in these young people. The Apps and Peer support for a Healthy future and Living Well with Diabetes (APHLID-M) multicentre study includes two randomised controlled trials (RCTs) testing such an app, aimed at reducing distress among young adults with diabetes with and without a mental health condition (MHC).</div></div><div><h3>Methods and analysis</h3><div>An app containing diabetes and MH resources was configured onto a pre-existing, digital health platform. Young adults aged 16–30 years with diabetes will be recruited from eight Australian outpatient clinics, screened using the Kessler Psychological Distress Scale (K10) and the Problem Areas in Diabetes (PAID) questionnaires. Based on MH status, participants will be allocated to the primary RCT (MHC group) or a nested-exploratory RCT (No-MHC group) and randomised by site to the “app” (Intervention) or “no app” (control). All participants will have access to peer support and will continue to receive standard diabetes care through their clinic. Recruitment will end once 142 participants are enrolled in the primary RCT. The primary outcome is change in psychological distress (K10), and the secondary outcome change in HbA1c, assessed at baseline and 6 months.</div></div><div><h3>Discussion</h3><div>APHLID-M will offer valuable insights into effects of digital technology in enhancing MH (particularly distress) physical health and well-being in young people with diabetes.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101484"},"PeriodicalIF":1.4,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143852342","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}

{"title":"Novel approaches to recruiting clinical sites for embedded pragmatic clinical trials: Insights from the AIM-back trial","authors":"Tyler L. Cope ,&nbsp;Steven Z. George ,&nbsp;S. Nicole Hastings ,&nbsp;Courtni France ,&nbsp;Christa Tumminello ,&nbsp;Cynthia J. Coffman ,&nbsp;Ashley Choate ,&nbsp;Trevor A. Lentz","doi":"10.1016/j.conctc.2025.101483","DOIUrl":"10.1016/j.conctc.2025.101483","url":null,"abstract":"<div><h3>Background</h3><div>Embedded pragmatic clinical trials (ePCTs) assess interventions in real-world settings. Best practices for recruiting clinical sites for ePCTs are unknown, especially for sites that aren't known to the study team or familiar with clinical research. We describe the site recruitment process for AIM-Back, an ePCT of two nonpharmacologic pathways for low back pain within the Veterans Health Administration (VA).</div></div><div><h3>Methods</h3><div>During the planning phase of the AIM-Back trial, we aimed to recruit 18–20 sites. Eligible sites required provider capacity, administrative support, and geographic separation to avoid contamination. Our three-step approach involved: (1) lead (VA personnel) identification through existing VA contacts, data repositories of VA clinicians, and promotional outreach at events and listservs; (2) lead engagement via tailored communications emphasizing participation benefits; and (3) virtual meetings with administrators and clinicians.</div></div><div><h3>Results</h3><div>We identified 184 leads across 53 VA healthcare systems. Leads from 40 systems responded to outreach, and recruitment meetings were conducted with 23 systems involving primary care, physical therapy, research staff, and leadership. We met our recruitment goal, securing participation agreements from 19 sites, with a median timeline from outreach to participation agreement of 3.7 months. Common reasons for non-participation included infrastructure and resource constraints, resistance to new clinical programs, and competing programs.</div></div><div><h3>Conclusion</h3><div>AIM-Back's recruitment highlights ePCT site recruitment complexities for trials engaging new clinical research sites. Our innovative three-step recruitment approach provides an example for similarly designed trials. Future ePCTs should consider comprehensive recruitment strategies to ensure clinician buy-in, study feasibility, and broaden existing networks for completing ePCTs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101483"},"PeriodicalIF":1.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143859283","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}

{"title":"Combined chiropractic care and Tai Chi for chronic neck pain: A protocol for a pilot randomized trial","authors":"Peter M. Wayne ,&nbsp;Robert Vining ,&nbsp;Cynthia R. Long ,&nbsp;Wren M. Burton ,&nbsp;Daniel Litrownik ,&nbsp;Jacqueline Guzman ,&nbsp;Karen Kilgore ,&nbsp;Thomas J. Hagan ,&nbsp;Pamela M. Rist ,&nbsp;Matthew H. Kowalski","doi":"10.1016/j.conctc.2025.101482","DOIUrl":"10.1016/j.conctc.2025.101482","url":null,"abstract":"<div><h3>Background</h3><div>Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains uncertain due to the multifactorial etiology of CNP. Two interventions, multimodal chiropractic care (MCC) and Tai Chi, have shown promise individually in managing CNP, and when combined may offer synergistic benefits. This pilot study aims to assess the feasibility of combining these interventions for CNP.</div><div>Methods/design: Forty-eight adults, aged 18-65y, with CNP defined as occurring ≥5 days a week for ≥3 consecutive months, severity of ≥3 on the numeric rating scale, and a score of ≥5 on the Neck Disability Index will be recruited. Participants will be randomized 1:1:1 to one of the three treatment groups (MCC plus Tai Chi and Enhanced Usual Care (EUC), MCC plus EUC, or EUC alone). The MCC was validated using a modified Delphi approach. Primary outcomes relate to feasibility (recruitment, retention, and adherence) and secondary outcomes include clinical measures of neck pain severity and disability, health-related quality-of-life, psychosocial well-being, and physical function. Outcomes will be assessed at baseline, 16-weeks (post-intervention), and 24-weeks. Qualitative interviews will be conducted.</div></div><div><h3>Discussion</h3><div>Results of this study will provide preliminary evidence regarding the feasibility and clinical evaluation of pragmatically delivered MCC, alone or in combination with Tai Chi, for individuals with CNP. These data will be used to inform the design of a fully powered, factorial trial evaluating two promising non-pharmacological therapies for CNP.</div></div><div><h3>Trial registration</h3><div>This study is registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT05726331).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101482"},"PeriodicalIF":1.4,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143859297","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}

{"title":"Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol","authors":"Nancy A. Hodgson ,&nbsp;Miranda V. McPhillips ,&nbsp;Karen B. Hirschman ,&nbsp;Emily Summerhayes ,&nbsp;Catherine Verrier Piersol ,&nbsp;Laura N. Gitlin","doi":"10.1016/j.conctc.2025.101478","DOIUrl":"10.1016/j.conctc.2025.101478","url":null,"abstract":"<div><h3>Background</h3><div>Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fraction of the many individuals living with dementia and their caregivers within in the US have access to evidence-based programs. A leading barrier to implementation of evidence-based dementia caregiver support programs into long-term care settings is the lack of streamlined, scalable, user-friendly, and tested training modalities.</div></div><div><h3>Objective</h3><div>To describe the protocol for a study evaluating the implementation of the Care of Persons in their Environment (COPE) in Programs of All-Inclusive Care for the Elderly (PACE) setting. The COPE in PACE study aims to determine if self-paced, online training in the evidence-based dementia care program COPE is non-inferior to the traditional, in-person, instructor-led training for improving clinician knowledge and competence, patient symptoms, function, caregiver confidence and burden, and therapeutic alliance between clinicians and caregivers.</div><div>Methods/Design: Pragmatic, multisite randomized controlled non-inferiority trial is being used to assess the implementation of COPE into PACE. The study utilizes a type III hybrid effectiveness design with a primary focus on measuring implementation factors and a secondary focus on measuring COPE effectiveness through caregiver and patient outcomes and therapeutic alliance. The ‘COPE in PACE’ study is an ongoing trial being conducted in 10 PACE settings throughout the US (NCT04165213).</div></div><div><h3>Discussion</h3><div>This study design has potential to guide future translational efforts by providing program adaptation, fidelity monitoring and implementation details to enhance scalability of evidence-based programs.</div></div><div><h3>Clinical trial registration</h3><div>NCT04165213.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101478"},"PeriodicalIF":1.4,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mixed-methods study on the recruitment of patients from ethnic minority groups to clinical trials in a central London teaching hospital","authors":"Cecilia Vindrola-Padros ,&nbsp;Katie Gilchrist ,&nbsp;Stuart Braverman ,&nbsp;Rumana Omar ,&nbsp;Edward Merivale ,&nbsp;Ambar Hussenbux ,&nbsp;Sanjay Khanna ,&nbsp;Patience Renias-Zuva ,&nbsp;Nick McNally ,&nbsp;Rosamund Yu","doi":"10.1016/j.conctc.2025.101475","DOIUrl":"10.1016/j.conctc.2025.101475","url":null,"abstract":"<div><h3>Background/aims</h3><div>Additional research is needed to fully understand barriers in recruitment to clinical trials and how these might affect different ethnic groups. The aim of this study was to explore the factors acting as barriers and facilitators in the process of recruiting patients to clinical trials in a UK (central London) teaching hospital, with a particular focus on patients from ethnic minority groups, and on areas where action could be taken.</div></div><div><h3>Methods</h3><div>The study was designed as a mixed-methods study comprised of: 1) a quantitative workstream which explored variations in the ethnic and gender breakdown of people admitted to hospital relative to the demographic characteristics of patients enrolled into research studies at the hospital, and 2) a qualitative workstream which explored staff experiences of recruiting patients to clinical trials and patients’ experiences of being approached to take part in a clinical trial. The quantitative workstream provided the necessary context for the design of the qualitative workstream.</div></div><div><h3>Results</h3><div>We found that the chances of being involved in research at the hospital were lower in all ethnic minority groups and lower amongst female patients. Some of the factors acting as barriers in trial participation included patients’ perceptions of clinical research as a form of experimental medicine that might have high risks, the role of family members in decision-making processes, and language barriers (where patients might not be fluent in English and the study information is not communicated in other languages). Potential strategies to address underrepresentation included the development of accessible information about research and how patient data are used, development of study materials in multiple languages and use of interpreters during the recruitment process, support for staff in involving family members in decision-making and a greater ethnic diversity within study teams.</div></div><div><h3>Conclusions</h3><div>The under-representation of people from minority ethnic populations in clinical research remains a major challenge, impacting on the rigour and applicability of findings as well as implying some populations are missing out on the benefits of research. Study design needs to place greater emphasis on patient need and convenience and therefore to take greater account of the deterrent effect of financial and time burdens on trial participants. Recruiting sites and sponsors need to review the provision of interpreting and translation support for trials, including availability and cost to individual studies and staff confidence in reliability.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101475"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addressing challenges and barriers to rural Veteran participation in clinical research within the Veterans Affairs healthcare system","authors":"Marcus R. Johnson ,&nbsp;Aliya Asghar ,&nbsp;Danielle J. Beck ,&nbsp;Tassos Kyriakides ,&nbsp;Matthew P. Vincenti ,&nbsp;Grant D. Huang","doi":"10.1016/j.conctc.2025.101466","DOIUrl":"10.1016/j.conctc.2025.101466","url":null,"abstract":"<div><div>The execution of clinical research in medical facilities that serve rural populations and/or that have lower care complexity levels has been proven to be challenging, as compared to larger healthcare institutions with higher complexity levels. Issues such as isolation, lack of organizational support and resources, difficulty with enrollment of study participants in rural settings, and challenges with identifying and retaining experienced clinical research staff serve as barriers to developing and establishing the necessary infrastructure to conduct clinical research at rural and/or smaller medical facilities. The United States (U.S.) Department of Veterans Affairs’ (VA) has the largest integrated health care system in the country and provides care to over 9 million Veterans. These considerations, combined with feedback collected from a subset of these types of (VA) Medical Centers (VAMCs) on this topic, demonstrate the need for a comprehensive enterprise-level strategy to address these challenges within the VA healthcare system. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure that has vast expertise in the conduct of multi-site clinical research within the VA and is well poised to lead this effort.</div><div>This manuscript describes the CSP “Advancing Capacity for Clinical Research through Engagement with Strategic Sites (ACCESS)” initiative. It focuses specifically on the successes, challenges, and lessons learned from the CSP ACCESS Workgroup (AW) during the development and implementation of a comprehensive pilot plan for engaging rural/lower complexity VAMCs (strategic sites) to participate in CSP clinical research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101466"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143777437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predicting clinical trial duration via statistical and machine learning models","authors":"Joonhyuk Cho ,&nbsp;Qingyang Xu ,&nbsp;Chi Heem Wong ,&nbsp;Andrew W. Lo","doi":"10.1016/j.conctc.2025.101473","DOIUrl":"10.1016/j.conctc.2025.101473","url":null,"abstract":"<div><div>We apply survival analysis as well as machine learning models to predict the duration of clinical trials using the largest dataset so far constructed in this domain. Neural network-based DeepSurv yields the most accurate predictions and we identify key factors that are most predictive of trial duration. This methodology may help clinical researchers optimize trial designs for expedited testing, and can also reduce the financial risk of drug development, which in turn will lower the cost of funding and increase the amount of capital allocated to this sector.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101473"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}