Contemporary clinical trials最新文献

{"title":"Unpacking the chain of change in group CBT and ACT for depression: A protocol for a randomized clinical trial.","authors":"Anh Dao, Rachel A Bernstein, Francisco N Ramos, Brittany Beasley, Iony D Ezawa","doi":"10.1016/j.cct.2025.107907","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107907","url":null,"abstract":"<p><strong>Background: </strong>Cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) are among our most effective treatments for depression, yet their efficacy remains modest. Prior research has not been able to improve these efficacy rates in part due to the limited insight into the processes of change in these treatments and which individuals may benefit more or less from different therapeutic processes.</p><p><strong>Method: </strong>One hundred adults with a diagnosis of major depressive disorder will be randomized to receive eight weeks of group CBT (n = 50) or ACT (n = 50). We will use intensive longitudinal sampling methods to examine therapeutic skills use, theorized treatment mechanisms, and treatment outcomes throughout the course of treatment. The primary aim is to examine the mediational effect of theorized treatment mechanisms on the association between therapeutic skills use and treatment outcomes. Our secondary aim is to examine the combined moderating effects of treatment modality and client characteristics on the association between therapeutic skills use and activation of mechanisms of change.</p><p><strong>Conclusion: </strong>This work has the potential to inform precision mental health care by closing in on the question of \"what works and for whom\" as it relates to data-driven psychotherapeutic interventions for depression.</p><p><strong>Trial registration number: </strong>The study is registered at www.</p><p><strong>Clinicaltrials: </strong>gov (NCT06245096).</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107907"},"PeriodicalIF":2.0,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143787781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Periurethral versus intravaginal application of vaginal estrogen for the prevention of urinary tract infections in postmenopausal women: Design of a randomized non-inferiority trial","authors":"Stephanie W. Zuo ,&nbsp;Megan Bradley ,&nbsp;Erin E. Mowers ,&nbsp;Halina M. Zyczynski ,&nbsp;Sharon L. Hillier ,&nbsp;Mary F. Ackenbom","doi":"10.1016/j.cct.2025.107893","DOIUrl":"10.1016/j.cct.2025.107893","url":null,"abstract":"<div><h3>Background</h3><div>Recurrent urinary tract infections (UTIs) disproportionately affect older women. Vaginal estrogen is the only non-antibiotic therapy with a Grade A recommendation for the prevention of UTIs in postmenopausal women, but it is associated with a high rate of non-adherence due to reported difficulties with vaginal application and concerns about exogenous hormone exposure. To alleviate these challenges, some women apply estrogen cream periurethrally, although evidence supporting this approach is lacking.</div></div><div><h3>Methods</h3><div>The <u>T</u>echniques of <u>AP</u>plying Vaginal <u>E</u>strogen for Prevention of <u>R</u>ecurrent Urinary Tract Infections (TAPER) trial is a randomized non-inferiority trial comparing the percentage of UTI-free participants after 6-months of vaginal estradiol via (1) intravaginal application of 1.0 g cream (standard) or (2) periurethral application of 0.5 g cream. Postmenopausal women with laboratory evidence of recurrent UTIs and without estrogen use in the prior 3 months were eligible. Secondary outcomes include urinary, sexual, and vulvovaginal symptoms, patient compliance, and translational measures, including change in vaginal pH, vaginal maturation index, and urinary and vaginal colonization by <em>Lactobacillus</em> and <em>Escherichia coli</em>.</div></div><div><h3>Results</h3><div>A total of 114 participants were randomized, and participants are currently in the follow-up phase.</div></div><div><h3>Conclusion</h3><div>This report highlights the study design and implementation challenges of the TAPER trial. Results from this trial will provide evidence regarding the effectiveness of intravaginal versus periurethral estradiol application for UTI prevention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107893"},"PeriodicalIF":2.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143760018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dose-finding designs for cell therapy cancer clinical trials evaluating drug-combinations","authors":"Evan M. Bagley ,&nbsp;Nolan A. Wages","doi":"10.1016/j.cct.2025.107894","DOIUrl":"10.1016/j.cct.2025.107894","url":null,"abstract":"<div><div>Cell therapies have taken hold as a promising modality of treatment for multiple types of cancer. Despite this, their efficacy as a monotherapy has been limited, driving interest in their possible role as part of a drug combination. This paper introduces a novel dose-finding design for phase I cancer trials assessing drug combinations where one of the drugs is a cell therapy. Our design adapts the partial order continual reassessment method (POCRM) to account for late-onset dose-limiting toxicities (DLT) and feasibility concerns due to complexities related to manufacturing the cell therapy product. We illustrate our design on a proposed trial to assess the combination of a Rituximab-based bispecific antibody activated T cell product and Nivolumab for the treatment of high-grade B-cell lymphoma. We also provide simulation results that demonstrate our design's ability to accurately identify the feasible maximum tolerated dose combination (FMTDC) while managing late-onset DLTs and feasibility concerns. Our methodology aims to improve the phase I drug combination landscape for cell therapy cancer clinical trials.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107894"},"PeriodicalIF":2.0,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"LIVING - protocol for a pragmatic randomized controlled trial investigating the effect of three different levels of diabetes self-management programs","authors":"Jonas Munk Jensen ,&nbsp;Karina Vejrum Sørensen ,&nbsp;Henrik Støvring ,&nbsp;Anette Andersen","doi":"10.1016/j.cct.2025.107891","DOIUrl":"10.1016/j.cct.2025.107891","url":null,"abstract":"<div><h3>Background</h3><div>In Denmark, Type 2 Diabetes (T2D) care includes diabetes self-management programs (DSMPs) delivered by municipalities. Following a successful pilot study, a DSMP was expanded to include a digital platform and flexible educational materials. While exercise therapy is recognized as essential in T2D management, high-quality studies on DSMPs incorporating exercise are limited. This trial assesses the (cost)effectiveness of three interventions with escalating intensity, hypothesizing that higher intensity enhances diabetes management competence and reduces complication risk.</div></div><div><h3>Methods/design</h3><div>A pragmatic randomized controlled trial will assess three different DSMP interventions in six Danish municipalities acting as trial sites. Each site will implement one of three versions of Lev Livet: a short version (SLL), a full version (FLL), or the full version with high intensity exercise (FLL + H). At each site, 48 participants will be randomly assigned (2:1) to intervention or control groups. Primary outcome is perceived competence in diabetes (questionnaire). Other outcomes measure physical activity level (accelerometer),HbA1c, disease progression, physical function, and self-reported metrics. The trial is approved by the Danish National Center for Ethics (case no 1–10–72-107-23) and registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06091501</span><svg><path></path></svg></span>).</div></div><div><h3>Discussion</h3><div>The LIVING trial has the potential to establish whether the Lev Livet program is effective and cost effective and how it can be implemented in municipalities. By analyzing dose-response relationships, the trial may refine intervention frequency and intensity, improve diabetes management, and inform both national and international guidelines for accessible, effective diabetes care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107891"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengthening older adults remembering (SOARing): Research protocol for a multi-site randomized clinical trial examining the efficacy of the Kessler Foundation modified story memory technique (KF-mSMT®) in mild cognitive impairment (MCI)","authors":"Nancy D. Chiaravalloti ,&nbsp;Erica Weber ,&nbsp;Ekaterina Dobryakova ,&nbsp;Jean Lengenfelder ,&nbsp;Tien T. Tong ,&nbsp;Kyler Mulhauser ,&nbsp;Nancy B. Moore ,&nbsp;Brionna Robinson ,&nbsp;Diana Maloku ,&nbsp;Amber Salter ,&nbsp;Nicholas M. Kanaan ,&nbsp;Silvana L. Costa ,&nbsp;Benjamin M. Hampstead","doi":"10.1016/j.cct.2025.107892","DOIUrl":"10.1016/j.cct.2025.107892","url":null,"abstract":"<div><h3>Background</h3><div>Long-term memory dysfunction is the hallmark feature of amnestic mild cognitive impairment (aMCI) resulting in substantial negative impact on everyday functioning and quality of life. The Kessler Foundation modified Story Memory Technique (KF-mSMT®) is a 10-session memory rehabilitation protocol in which participants are taught to utilize imagery and context to facilitate learning. This paper describes the protocol for a double blind, placebo controlled, randomized clinical trial (RCT) examining the efficacy of the KF-mSMT® in persons who meet criteria for aMCI.</div></div><div><h3>Methods</h3><div>Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and a blood draw for measuring plasma biomarkers. Participants will then be randomized to one of two conditions using concealed allocation: KF-mSMT® or an active placebo control condition consisting of memory exercises. Participants will be blinded to condition. Within 2 weeks of completing the intervention, participants will complete the same measures as at baseline administered by treatment-blinded assessors. The primary study outcome is new learning and memory measured by neuropsychological assessment (Open Trial Selective Reminding Test). Secondary outcomes include other measures of learning and memory (i.e. Repeatable Battery for the Assessment of Neuropsychological Status story), visuospatial memory (Brief Visuospatial Memory Test-Revised)) as well as everyday memory (Ecological Memory Simulations, Object Location Touchscreen Test), neuroimaging and plasma biomarkers.</div></div><div><h3>Conclusion</h3><div>If successful, this trial will provide Class I evidence supporting the application of the KF-mSMT® for treating MCI-related learning and memory decline in older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107892"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of out-of-pocket cost COMmunication and financial navigation (CostCOM) in cancer patients: Study protocol for ECOG-ACRIN EAQ222CD","authors":"Gelareh Sadigh ,&nbsp;Fenghai Duan ,&nbsp;Ilana F. Gareen ,&nbsp;Judy Hancock ,&nbsp;JoRean D. Sicks ,&nbsp;Sarah Hawley ,&nbsp;Veena Shankaran ,&nbsp;Mylin Torres ,&nbsp;Lynne I. Wagner ,&nbsp;Ruth C. Carlos","doi":"10.1016/j.cct.2025.107889","DOIUrl":"10.1016/j.cct.2025.107889","url":null,"abstract":"<div><h3>Background</h3><div>High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance.</div></div><div><h3>Methods</h3><div>This is a two-arm randomized controlled trial enrolling 720 patients with newly diagnosed solid tumors (stratified by non-metastatic vs. metastatic) who plan to receive anticancer systemic therapy at one of the participating NCI Community Oncology Research Practices (NCORP). Participants are randomized to receive four up to 1-h remote counseling sessions which include systemic therapy OOP cost communication, financial navigation and counseling (CostCOM intervention) vs. enhanced usual care with provision of an informational brochure for Patient Advocate Foundation (PAF), a national non-profit financial navigation organization (EUC). Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to compare the effectiveness of CostCOM vs. EUC at 12 months on (1) patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns and (2) patient-reported material financial hardship, financial worry, and quality of life; and to (3) conduct a process evaluation to examine practice providers' and CostCOM arm patients' satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM. A successful CostCOM is a scalable and financially sustainable program that can improve cancer care delivery, patients' experience, and health outcomes.</div><div>Trial registration: <span><span>NCT06295367</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107889"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a seamless phase 2/3 study design in the setting of an emergent infectious disease pandemic: Lessons learned from the ACTIV-2 platform COVID-19 treatment trial","authors":"Mark J. Giganti ,&nbsp;Kara W. Chew ,&nbsp;Carlee Moser ,&nbsp;Joseph J. Eron ,&nbsp;Mauricio Pinilla ,&nbsp;Jonathan Z. Li ,&nbsp;Justin Ritz ,&nbsp;Arzhang Cyrus Javan ,&nbsp;David Alain Wohl ,&nbsp;Eric S. Daar ,&nbsp;Judith S. Currier ,&nbsp;Davey M. Smith ,&nbsp;Michael D. Hughes ,&nbsp;the ACTIV-2/A5401 Study Team","doi":"10.1016/j.cct.2025.107887","DOIUrl":"10.1016/j.cct.2025.107887","url":null,"abstract":"<div><div>Seamless phase 2/3 study designs provide a framework for a more efficient trial. During the COVID-19 pandemic, such study designs were considered particularly appealing as there was an urgent global need to rapidly identify effective therapeutics. However, limited in vivo safety and efficacy data was available early in the pandemic to inform decisions. As part of the ACTIV-2 study, we implemented a phase 2/3 platform trial to evaluate multiple candidate treatments for non-hospitalized adults with COVID-19. In addition to an adequate safety profile, the decision to graduate an agent from phase 2 to phase 3 was based on showing treatment effects on clinical or laboratory markers. Decision criteria evolved over time as more data became available during the global pandemic. A seamless transition and approximately 20 % reduction in total sample size was achieved for one agent, amubarvimab plus romlusevimab. Using both simulation studies and actual results from graduation assessments of five ACTIV-2 candidate therapeutics, we provide a discussion of lessons learned from our implementation and recommendations for future seamless trials of interventions for emergent infections.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107887"},"PeriodicalIF":2.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143729187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-related distress among head and neck cancer survivors","authors":"Evan M. Graboyes ,&nbsp;Stacey N. Maurer ,&nbsp;Emily Kistner-Griffin ,&nbsp;Kent Armeson ,&nbsp;Ella Starr ,&nbsp;Taylor McLeod ,&nbsp;Wendy E. Balliet ,&nbsp;Jacquelyn Doenges ,&nbsp;Olga Slavin-Spenny ,&nbsp;Jessica R. Vanderlan ,&nbsp;Andrew Day ,&nbsp;Patrik Pipkorn ,&nbsp;Sidharth V. Puram ,&nbsp;Samantha H. Tam ,&nbsp;Kenneth J. Ruggiero ,&nbsp;Katherine R. Sterba","doi":"10.1016/j.cct.2025.107888","DOIUrl":"10.1016/j.cct.2025.107888","url":null,"abstract":"<div><div>One in four head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a devastating psychosocial morbidity that adversely affects quality of life. To date, effective interventions for these patients are lacking. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief cognitive behavioral treatment (CBT), has shown potential efficacy as a novel treatment paradigm for HNC survivors with BID. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that BRIGHT improves BID among HNC survivors relative to an Attention Control (AC) intervention. In this multisite RCT, <em>N</em> = 180 HNC survivors with BID will be randomized 1:1 to six weeks of BRIGHT or AC of dose and delivery-matched survivorship education. Outcomes are assessed at baseline and 2, 3, 6, and 9-months post-randomization. The primary endpoint is the IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck) score, a validated patient-reported outcome of HNC-related BID. Secondary endpoints include the HN Shame and Stigma Scale, the PROMIS SF v1.0-Depression 8a, Anxiety 8a, and Ability to Participate in Social Activities 8a, the Beck Scale for Suicidal Ideation, and the EORTC QLQ-HN35 Trouble with Social Eating and Trouble with Social Contact subscales. The trial will also evaluate whether the effect of BRIGHT on BID is mediated through improvements in automatic thinking and body image coping strategies. Findings from this multisite RCT will provide a rigorous test of the efficacy of BRIGHT as the first evidence-based strategy to manage BID among HNC survivors.</div></div><div><h3>Trial registration ID</h3><div><span><span>NCT05442957</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107888"},"PeriodicalIF":2.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator","authors":"Yaoshi Wu ,&nbsp;John Kolassa ,&nbsp;Ning Dong","doi":"10.1016/j.cct.2025.107877","DOIUrl":"10.1016/j.cct.2025.107877","url":null,"abstract":"<div><h3>Objective</h3><div>The purpose of the paper is to introduce the Wu-Kolassa estimator (WKE) and the RMST based on it for its less biased estimation and substantial power gain, compared to the Kaplan-Meier estimator (KME), to researchers working in medical and health sciences to evaluate and compare patient survival times.</div></div><div><h3>Results</h3><div>The seven numerical studies showed that the power gain in WKE-based RMST analysis can reach more than 80 %, depending on the size of the study and the trend of failure rate. For the phase III study of iniparib plus gemcitabine and carboplatin (GCI) versus gemcitabine and carboplatin (GC) in patients with metastatic triple-negative breast cancer, GCI is superior to GC demonstrated by WKE-based RMST analysis (point estimate of treatment difference in RMST = 0.807; 95 % CI: 0.0214 to 1.592, 1.5 times higher than the estimate based on KME = 0.542; 95 % CI: −0.385 to 1.470). For the phase III trial that studied ovarian suppression (os) with tamoxifen or exemestane, tamoxifen plus os is superior to tamoxifen alone using WKE-based RMST (point estimate of difference = 0.228; 95 % CI: 0.016 to 0.439, more than 2-fold higher than the estimated difference based on KME = 0.113; 95 % CI: −0.008 to 0.234).</div></div><div><h3>Conclusions</h3><div>The Wu-Kolassa estimator is superior to the Kaplan-Meier estimator as it reduces the estimation bias and increases the power in the RMST analysis when the censoring rate is high or when the reference group has more censoring data than the test group.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107877"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143680513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An adaptive imputation method of missing data for sparsely retrieved dropouts in treatment policy strategy","authors":"Chuanji Yuan ,&nbsp;Zhenyu Yang ,&nbsp;Jiaqing Liu ,&nbsp;Xiaozhou Li ,&nbsp;Bokai Chen ,&nbsp;Tao Han ,&nbsp;Qian Yu ,&nbsp;Zuojing Li","doi":"10.1016/j.cct.2025.107886","DOIUrl":"10.1016/j.cct.2025.107886","url":null,"abstract":"<div><div>The ICH E9 R1 Addendum suggests using a treatment-policy strategy as an approach to handle intercurrent events for estimating de facto estimand. Under this strategy, regardless of the occurrence of intercurrent events, the value for the variable of interest is analyzed. After discontinuing treatment, participants who remain in the trial to complete the assessment of the primary endpoints are referred to as retrieved dropouts, while early withdrawal by participants results in missing data. To mitigate the effects of missing data, strategies like mixed model for repeated measures or the retrieved dropout multiple imputation method are used. The bias of retrieved dropout methods is relatively small. However, if retrieved dropouts are scarce, it could significantly inflate variance.</div><div>This article introduces an innovative adaptive model that refines the On/Off Intercepts with Common Slopes using Residuals (RD_OICSR) model, which is a model within the retrieved dropout methods, and evaluates it using simulated data from a depression trial. The findings indicate that when the proportion of retrieved dropouts falls below the predetermined threshold set by researchers, our method minimizes unrealistic variance inflation by incorporating data from placebo completers. Conversely, the model adaptively matches the RD_OICSR model. This ensures that irrespective of the retrieved dropouts' proportions, the analysis remains accurate.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107886"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}