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
{"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}
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
{"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}
Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino
{"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}
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
{"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}
Lauren Rogak , Jamie K. Forschmiedt , Ethan Basch , Gina L. Mazza , Minji K. Lee , Eric A. Meek , Brenda Ginos , Blake T. Langlais , Brie N. Noble , Allison M. Deal , Claire Yee , Gita Thanarajasingam , Amylou C. Dueck
{"title":"Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials","authors":"Lauren Rogak , Jamie K. Forschmiedt , Ethan Basch , Gina L. Mazza , Minji K. Lee , Eric A. Meek , Brenda Ginos , Blake T. Langlais , Brie N. Noble , Allison M. Deal , Claire Yee , Gita Thanarajasingam , Amylou C. Dueck","doi":"10.1016/j.conctc.2025.101547","DOIUrl":"10.1016/j.conctc.2025.101547","url":null,"abstract":"<div><div>The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (<em>P</em> < .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101547"},"PeriodicalIF":1.4,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145004165","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}
Carlos Almonacid , Borja G. Cosío , Xavier Muñoz Gall , Manuel Santiñà Vila , Jaime Signes-Costa , José Luis Velasco Garrido , Mercedes Luz , Marta Rodríguez , Alberto Godos , Ana Pérez Domínguez , Eunice Funenga , Carmen Moreno
{"title":"Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences","authors":"Carlos Almonacid , Borja G. Cosío , Xavier Muñoz Gall , Manuel Santiñà Vila , Jaime Signes-Costa , José Luis Velasco Garrido , Mercedes Luz , Marta Rodríguez , Alberto Godos , Ana Pérez Domínguez , Eunice Funenga , Carmen Moreno","doi":"10.1016/j.conctc.2025.101544","DOIUrl":"10.1016/j.conctc.2025.101544","url":null,"abstract":"<div><div>Clinical trials (CT) are the framework upon which novel treatments' safety and efficacy are assessed. The CARABELA-CT initiative aims to optimise Spanish CT procedures by improving efficiency, quality, and subject well-being. To this, it characterised CT healthcare models, identified improvement areas, proposed solutions, and gathered important insights from CT subjects. CARABELA-CT took a three-phase approach. Phase I involved CT healthcare models’ characterisation, including all clinical investigation processes in Spain, across six pilot hospitals, identifying improvement areas and solutions. Phase II validated these findings, defining key healthcare quality indicators. Phase III focused on dissemination and implementation. Additionally, seven randomly invited CT subjects participated in a focus group to share their experiences regarding communication, coordination, and CT impact on quality of life. Three CT healthcare models were identified, distinguished according to access, infrastructure, and resources. Twelve improvement areas were defined, leading to 38 solutions addressing subject education, professional training, organisation, protocols, resources, and technology. Twenty-four healthcare quality indicators were established to monitor CT processes. Subject experiences highlighted the need for clearer communication, digitalised information, and improved subject support, and revealed the emotional and psychological benefits of CT participation, despite the challenges. CARABELA-CT provides a comprehensive framework to enhance Spanish CT processes. This initiative integrates potential solutions in improvement areas in CT development and the corresponding healthcare quality indicators, and prioritises subject experiences to foster efficiency, participant engagement, and a sustainable, patient-centric clinical research model. These findings contribute to the continuous improvement of CT management, ultimately optimising research execution and healthcare outcomes.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101544"},"PeriodicalIF":1.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145050425","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}
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
{"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":"2025-08-29","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}
Consolato M. Sergi MD, PhD, MPH, FRCPC, FCAP Chief , Howard D. Sesso
{"title":"Artificial Intelligence and the future of clinical trials","authors":"Consolato M. Sergi MD, PhD, MPH, FRCPC, FCAP Chief , Howard D. Sesso","doi":"10.1016/j.conctc.2025.101545","DOIUrl":"10.1016/j.conctc.2025.101545","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101545"},"PeriodicalIF":1.4,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145095027","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}
Elena T. Remillard , Tracy L. Mitzner , Kara T. Mumma
{"title":"Tele Tai Chi for people aging with mobility disabilities: Novel methodology and structured adaptation approach","authors":"Elena T. Remillard , Tracy L. Mitzner , Kara T. Mumma","doi":"10.1016/j.conctc.2025.101543","DOIUrl":"10.1016/j.conctc.2025.101543","url":null,"abstract":"<div><div>Many people aging with mobility disabilities experience barriers engaging in exercise programs and social events in-person and could benefit from virtual programs that make participation more accessible. The Tele Tai Chi clinical trial is assessing the acceptability and effectiveness of an evidence-based in-person Tai Chi program for older adults, Tai Chi for Arthritis and Fall Prevention (seated version), when adapted to be an online group intervention (via videoconferencing) with moderated social time for individuals aging with mobility disabilities. Specifically, we are examining the intervention efficacy for the target population for increasing physical activity and social connectedness, which are the primary outcome measures. Secondary outcome measures include exercise self-efficacy, falls efficacy, depression, quality of life, and pain. The participant sample (N = 60) includes community-dwelling adults (60–77 years of age) with a self-identified mobility disability (i.e., using a mobility aid or having serious difficulty walking or climbing stairs) for at least 10 years. Follow-up assessments occurred at the end of the 8-week intervention and 1 month thereafter. This methods-focused paper highlights our novel, user-centered, technology-mediated approach to adapting an in-person intervention for individuals aging with mobility disabilities, which can be used as a roadmap for researchers and practitioners launching similar trials or programs.</div></div><div><h3>ClinicalTrials.gov no</h3><div>NCT04696887.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101543"},"PeriodicalIF":1.4,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144931927","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":"Reconstructing patient level survival data from published Kaplan-Meier curves","authors":"Jaromme Kim, Prabhakar Chalise, Jianghua He","doi":"10.1016/j.conctc.2025.101542","DOIUrl":"10.1016/j.conctc.2025.101542","url":null,"abstract":"<div><h3>Introduction</h3><div>Individual-level patient data (IPD) are helpful for designing clinical trials, conducting meta-analyses, or methodology research. However, such patient level data are not readily available. Multiple methods have been developed for reconstructing survival data using published Kaplan-Meier (KM) survival curves. There has been no practical guidance on an optimal approach or extensive evaluation of the performance of the approach.</div></div><div><h3>Methods</h3><div>We reviewed several methods of extracting the coordinates of KM survival curves and reconstructing individual-level survival data. Then, we reproduced data from 46 published KM curves. The accuracy of reconstructed data is quantified by comparing hazard ratios (HRs) and their confidence intervals (CIs) estimated from the reproduced data with those reported in the original papers.</div></div><div><h3>Results</h3><div>The comparison showed a high degree of similarity between the reproduced and original HRs and CIs. In most cases, the differences were less than 5 %. The mean and median absolute percentage differences of 58 reconstructed HRs were 2.85 % and 2.14 %, respectively. These results suggest the reconstruction method reliably reconstructs survival data from KM survival curves.</div></div><div><h3>Conclusions</h3><div>Based on an extensive number of reconstructions, we demonstrated that reconstructed data provided similar estimates overall to those from published papers. The quality of the reproduced data depends on the presence of noise in the published curves and whether the preprocessing step is properly done.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101542"},"PeriodicalIF":1.4,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144904464","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}