Contemporary Clinical Trials Communications最新文献

{"title":"Noninvasive anatomical assessment for ruling out hemodynamically relevant coronary artery anomalies in adults – A comparison of coronary-CT to invasive coronary angiography: The NARCO study design","authors":"Marius R. Bigler ,&nbsp;Anselm W. Stark ,&nbsp;Isaac Shiri ,&nbsp;Joel Illi ,&nbsp;Matthias Siepe ,&nbsp;Federico Caobelli ,&nbsp;Andreas A. Giannopoulos ,&nbsp;Ronny R. Buechel ,&nbsp;Andreas Haeberlin ,&nbsp;Dominik Obrist ,&nbsp;Lorenz Räber ,&nbsp;Christoph Gräni","doi":"10.1016/j.conctc.2024.101394","DOIUrl":"10.1016/j.conctc.2024.101394","url":null,"abstract":"<div><h3>Background</h3><div>Anomalous aortic origin of a coronary artery (AAOCA) is a rare congenital heart disease, potentially leading to myocardial ischemia and adverse cardiac events. As the sole presence of AAOCA does not always imply a revascularization, a detailed anatomical and functional analysis is crucial for clinical decision-making. Currently, invasive coronary angiography is the gold-standard method for a thorough hemodynamic assessment of AAOCA. However, due to its invasive nature, the development of noninvasive diagnostic alternatives is desired.</div></div><div><h3>Methods</h3><div>In the NARCO trial, patients with AAOCA will undergo coronary computed tomography angiography (CCTA) to assess anatomical high-risk features followed by a vessel-based (i.e. invasive measurement with fractional flow reserve and intravascular imaging under a dobutamine-volume challenge) and a myocardium-based (i.e. nuclear imaging) ischemia testing. Comparison of noninvasive and invasive imaging will be performed. Additionally, explorative analysis of post-processing advanced computational fluid dynamics (CFD) and 3D printing will be performed to unravel the pathophysiologic mechanism of myocardial ischemia in AAOCA.</div></div><div><h3>Aims</h3><div>Our primary aim is to define characteristics of anatomical high-risk features (using CCTA) to rule out noninvasively hemodynamically relevant anomalous vessels in AAOCA patients. The secondary aim is to investigate the underlying pathophysiology of AAOCA-related hemodynamic relevance using advanced techniques such as CFD and 3D printing.</div></div><div><h3>Conclusions</h3><div>The NARCO trial will help to optimize AAOCA patient selection for revascularization by improving risk stratification and ruling out hemodynamic relevance noninvasively and, therefore, preventing unnecessary downstream testing and/or costly interventions in patients with AAOCA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101394"},"PeriodicalIF":1.4,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702607","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":"Defining methods to improve eSource site start-up practices","authors":"Amy E. Cramer ,&nbsp;Linda S. King ,&nbsp;Michael T. Buckley ,&nbsp;Peter Casteleyn ,&nbsp;Cory Ennis ,&nbsp;Muayad Hamidi ,&nbsp;Gonçalo M.C. Rodrigues ,&nbsp;Denise C. Snyder ,&nbsp;Aruna Vattikola ,&nbsp;Eric L. Eisenstein","doi":"10.1016/j.conctc.2024.101391","DOIUrl":"10.1016/j.conctc.2024.101391","url":null,"abstract":"<div><h3>Background</h3><div>eSource software that transfers patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. Integrating eSource into multicenter clinical trial start-up procedures could facilitate the use of eSource technologies in clinical trials.</div></div><div><h3>Methods</h3><div>We conducted a qualitative integrative analysis to identify eSource site start-up key steps, challenges that might occur in executing those steps, and potential solutions to those challenges. We then conducted a value analysis to determine the challenges and solutions with the greatest impacts for eSource implementation teams.</div></div><div><h3>Results</h3><div>There were 16 workshop participants: 10 pharmaceutical sponsor, 3 academic site, and 1 eSource vendor representative. Participants identified 36 Site Start-Up Key Steps, 11 Site Start-Up Challenges, and 14 Site Start-Up Solutions for eSource-enabled studies. Participants also identified 77 potential impacts of the Challenges upon the Site Start-Up Key Steps and 70 ways in which the Solutions might impact Site Start-Up Challenges. The most important Challenges were: [1] not being able to identify a site eSource champion and [2] not agreeing on an eSource approach. The most important Solutions were: [1] eSource vendors accepting electronic data in the Health Level 7 Fast Healthcare Interoperability Resources (HL7® FHIR®) standard, [2] creating standard content for eSource-related legal documents, and [3] creating a common eSource site readiness checklist.</div></div><div><h3>Conclusions</h3><div>Site start-up for eSource-enabled multi-center clinical trials is a complex socio-technical problem. This study's Start-Up Solutions provide initial steps for scalable eSource implementation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101391"},"PeriodicalIF":1.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702692","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 Bayesian adaptive feasibility design for rare diseases","authors":"Maureen M. Churipuy ,&nbsp;Shirin Golchi ,&nbsp;Marie Hudson ,&nbsp;Sabrina Hoa","doi":"10.1016/j.conctc.2024.101392","DOIUrl":"10.1016/j.conctc.2024.101392","url":null,"abstract":"<div><div>It is important for researchers to carefully assess the feasibility of a clinical trial prior to the launch of the study. One feasibility aspect that needs to be considered includes whether investigators can expect to successfully achieve the sample size needed for their trial. In this manuscript, we present a Bayesian design in which data collected during a pilot study is used to predict the feasibility of a planned phase III trial. Specifically, we outline a model that predicts a target sample size obtained from the Gamma-Poisson distribution. In a simulation study, we showcase the utility of the proposed design by applying it to a phase III trial designed to assess the efficacy of mycophenolate mofetil in individuals with mild systemic sclerosis. We demonstrate that the predictive nature of the proposed design is particularly useful for rare disease clinical trials and has the potential to greatly increase their efficiency.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101392"},"PeriodicalIF":1.4,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652494","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":"Reasons for declining participation in inpatient research among historically minoritized racial and ethnic communities: A scoping review","authors":"Poyani Bavishi ,&nbsp;Alyssa A. Grimshaw ,&nbsp;Oscar F. Rojas Perez ,&nbsp;Brian D. Kiluk ,&nbsp;E. Jennifer Edelman","doi":"10.1016/j.conctc.2024.101386","DOIUrl":"10.1016/j.conctc.2024.101386","url":null,"abstract":"<div><h3>Background</h3><div>To promote equitable recruitment for studies conducted in the inpatient hospital setting, we sought to characterize reasons why individuals, both from historically minoritized racial and ethnic groups and the broader patient population, refuse participation in clinical trials within inpatient settings.</div></div><div><h3>Methods</h3><div>An exhaustive search of the literature was conducted in Cochrane Library, Google Scholar, Embase, MEDLINE, PubMed, Scopus, and Web of Science databases to find relevant articles published from the inception of each database to April 30, 2023. Studies recruiting patients during their inpatient stay and reporting reasons for refusing participation in clinical trials met the inclusion criteria.</div></div><div><h3>Results</h3><div>The search resulted in 2264 citations, of which 22 were included. Fourteen did not report data related to race, while 19 reported no ethnicity data. Reasons for refusal across trials included study burden and inconvenience (n = 16), transportation and logistical issues (n = 13), lack of interest in research (n = 12), and refusal to be randomized (n = 10). Prominent concepts included the importance of incorporating social support systems in consenting processes, lack of efforts to include data or recruitment efforts for individuals from minoritized groups, and physician involvement in recruitment.</div></div><div><h3>Discussion</h3><div>To enhance participation among historically minoritized communities in clinical trials, greater efforts must be made to collect demographic information and document refusal reasons to inform future recruitment methods. Strategies include proactively accounting for culture and language differences in study design and recruitment and intentionally engaging social support networks. Limiting study burden and logistics and optimizing collaborations between clinical and research teams would promote accessibility and foster patient trust.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101386"},"PeriodicalIF":1.4,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702608","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":"Modeling severe uncontrolled asthma: Transitioning away from health states","authors":"Tereza Lanitis ,&nbsp;Asif H. Khan ,&nbsp;Irina Proskorovsky ,&nbsp;Ivan Houisse ,&nbsp;Andreas Kuznik ,&nbsp;Siddhesh Kamat ,&nbsp;Conrado Franco-Villalobos ,&nbsp;Florence Joulain","doi":"10.1016/j.conctc.2024.101390","DOIUrl":"10.1016/j.conctc.2024.101390","url":null,"abstract":"<div><h3>Background</h3><div>Models developed to date to simulate long-term outcomes of asthma have been criticized for lacking granularity and ignoring disease heterogeneity.</div></div><div><h3>Objective</h3><div>To propose an alternative approach to modeling asthma and apply it to model long-term outcomes in a population with moderate-to-severe type 2 asthma (patients with raised fractional exhaled nitric oxide or eosinophils) and treated with conventional therapy.</div></div><div><h3>Methods</h3><div>A discretely integrated condition event (DICE) approach was adopted, simulating individual profiles with asthma over patients’ lifetime in terms of exacerbations, asthma-related death, and death unrelated to asthma. The timing of these events is dependent on profile characteristics including lung function, asthma control, exacerbation history, and other baseline characteristics or contextual factors. Predictive equations were derived from a clinical trial to model time to exacerbation, change in asthma control, lung function, and utility. Real-world studies were used to supplement data gaps. Outcomes evaluated included life expectancy, quality-adjusted life-years (QALY), number of exacerbations, and lung function over time.</div></div><div><h3>Results</h3><div>Average annual rates of severe and moderate exacerbations were 1.82 and 3.08 respectively, with rates increasing over time. Lung function declined at a higher rate compared with the general population. Average life expectancy was 75.2 years, compared with 82.4 years in a matched general population. The majority of life-years were spent with uncontrolled asthma and impaired lung function.</div></div><div><h3>Conclusion</h3><div>Patients with moderate-to-severe type 2 asthma and a history of exacerbations suffer from frequent exacerbations and reduced lung function and life expectancy. Capturing multiple conditions to simulate long-term outcomes in patients with asthma may provide more realistic projections of exacerbation rates.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101390"},"PeriodicalIF":1.4,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702606","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 protocol for modifying progesterone to increase postpartum cigarette smoking abstinence and reduce secondhand smoke exposure in infants","authors":"Nermine Abdelwahab ,&nbsp;Alicia Allen ,&nbsp;Katherine Harrison ,&nbsp;Ashley Petersen ,&nbsp;Sharon Allen","doi":"10.1016/j.conctc.2024.101389","DOIUrl":"10.1016/j.conctc.2024.101389","url":null,"abstract":"<div><div>New interventions are necessary to increase postpartum abstinence from cigarette smoking. Sex hormones, specifically progesterone, have been found to be protective against drug-taking behaviors. Our pilot double-blind, randomized, controlled trial, although underpowered, suggested a trend toward a higher prevalence of smoking abstinence among postpartum participants receiving exogenous progesterone compared to those receiving placebo. This paper outlines the protocol used in our study to evaluate the efficacy of modifying progesterone to increase postpartum smoking abstinence and, subsequently, decrease secondhand smoke exposure in infants. In the intervention arm, participants will receive open-label exogenous oral progesterone (200 mg twice daily). Using a concurrent control group that does not receive progesterone treatment, we hypothesize that progesterone treatment will increase postpartum smoking abstinence as measured using a 7-day point prevalence at six months post-treatment allocation, as well as reduce smoking-related risk factors. Secondary objectives include examining the impact of this maternal smoking intervention on infant health. In addition to describing the protocol, we also discuss the protocol changes made due to the COVID-19 pandemic. Upon completion, this study will provide new information on how sex hormones may influence smoking cessation in postpartum populations, which can have broad public health implications.</div></div><div><h3>Clinical trials registration #</h3><div>NCT04783857.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101389"},"PeriodicalIF":1.4,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652496","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":"An automated platform trial framework for A/B testing","authors":"Wenru Zhou ,&nbsp;Miranda Kroehl ,&nbsp;Maxene Meier ,&nbsp;Alexander Kaizer","doi":"10.1016/j.conctc.2024.101388","DOIUrl":"10.1016/j.conctc.2024.101388","url":null,"abstract":"<div><div>This paper proposes a platform trial for conducting A/B tests with multiple arms and interim monitoring to investigate the impact of several factors on the expected sample size and probability of early stopping. We examined the performance of three stopping boundaries: O’Brien Fleming (OBF) stopping for either futility or difference (both), Pocock stopping for futility only, and fixed sample size design. We simulated twelve scenarios of different orders of arms based on various effect sizes, as well as considered 1 or 3 interim looks. The overall findings are summarizing in a flowchart to provide intuitive guidance for the design of the platform based on the simulation. We found that it is better to use OBF stopping for both if there is any effective variant and the trial is sufficiently powered to detect the expected effect size. If the study is underpowered to detect a difference, we recommend fixed sample size design to gather as much information as possible, however if the expected sample size is important to minimize, we recommend using Pocock boundaries with futility monitoring. Our results aimed at helping high-tech companies conduct their own studies without requiring extensive knowledge of clinical trial design and statistical methodology.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101388"},"PeriodicalIF":1.4,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652493","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":"Personalizing cognitive processing therapy with a case formulation approach to intentionally target impairment in psychosocial functioning associated with PTSD","authors":"T.E. Galovski ,&nbsp;L.B. McSweeney ,&nbsp;R.D.V. Nixon ,&nbsp;J.S. Wachen ,&nbsp;B.N. Smith ,&nbsp;S. Noorbaloochi ,&nbsp;D. Vogt ,&nbsp;B.L. Niles ,&nbsp;S.M. Kehle-Forbes","doi":"10.1016/j.conctc.2024.101385","DOIUrl":"10.1016/j.conctc.2024.101385","url":null,"abstract":"<div><div>Posttraumatic stress disorder (PTSD) is a debilitating condition often accompanied by significant functional impairments affecting quality of life and well-being. While Cognitive Processing Therapy (CPT) is a leading, evidence-based psychotherapy for PTSD, demonstrating substantial efficacy in core symptom reduction, its impact on psychosocial functioning is less well-established. The Personalizing Cognitive Processing Therapy with a Case Formulation Approach (Personalizing Approaches to Therapy: PATh) study aims to enhance CPT by explicitly targeting functional impairments and idiosyncratic challenges to optimal therapy outcomes (COTOs), comparing its efficacy against standard CPT in improving psychosocial functioning, quality of life, well-being, and core PTSD and depression symptoms. This randomized controlled trial involves 200 Veterans across eight Veterans Health Administration clinical sites, assigned to either Case Formulation CPT (CF-CPT) or standard CPT. Providers will deliver up to 20 sessions per patient, with assessments at baseline, mid-treatment, post-treatment, and three months follow-up. It is hypothesized that Veterans receiving CF-CPT will show greater improvements in functioning, quality of life, well-being, and symptom reduction, alongside higher treatment completion rates compared to standard CPT. Secondary outcomes will examine specific clinical challenges and their influence on treatment outcomes. This study investigates whether a personalized, flexible CPT protocol can enhance functional recovery in PTSD treatment without compromising the efficacy of the traditional approach, potentially impacting clinical practices and patient outcomes by promoting holistic recovery for veterans with PTSD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101385"},"PeriodicalIF":1.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142652495","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":"Personalized tourniquet pressure versus uniform tourniquet pressure in orthopedic trauma surgery of extremities: A prospective randomized controlled study protocol","authors":"Zhi-jian Sun ,&nbsp;Cheng-hui Chen ,&nbsp;Zhe-lun Tan ,&nbsp;Chang-run Li ,&nbsp;Han Fei ,&nbsp;Xiang Yu ,&nbsp;Dong-chen Yao ,&nbsp;Ting Li","doi":"10.1016/j.conctc.2024.101376","DOIUrl":"10.1016/j.conctc.2024.101376","url":null,"abstract":"<div><h3>Background</h3><div>In the field of orthopedic surgery, tourniquets are often used to achieve a clear operative field, expedite operations, and minimize hemorrhagic events. However, determining the optimal tourniquet inflation pressure is a topic of debate. The current approach involves using a constant tourniquet pressure, although this is associated with the potential to augment the risk of tourniquet-associated complications. The Association of Surgical Technologists recommends a tourniquet pressure of systolic blood pressure plus 50 mm Hg for the upper limb and 100 mm Hg for the lower limb. Nevertheless, this method lacks robust support from high-quality medical literature. Therefore, the study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method. The findings might outline the theoretical framework necessary for advocating for tourniquet pressure setups guided by systolic blood pressure.</div></div><div><h3>Methods/design</h3><div>This randomized controlled study classified the tourniquet pressure regimen into two groups: one based on the patient's systolic blood pressure (the study group) and the other using a constant pressure (the control group). The study included patients aged between 16 and 70 who presented with fresh fractures (less than 3 weeks) of the lower and upper limbs. All the included patients required surgical treatment involving the intraoperative use of a tourniquet and had no contraindications to this surgery. Our primary outcome was to assess the surgeon's satisfaction with the hemostasis achieved in the operative field. We also examined the changes in the circumference of the limb where the tourniquet was applied and tracked any postoperative complications and their incidence. The study ultimately encompassed 144 patients.</div></div><div><h3>Discussion</h3><div>Despite the prevalent use of tourniquets in surgical operations related to limb fractures, conflicting viewpoints persist concerning the adjustments in pressure and other elements. The study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method.</div></div><div><h3>Study registration</h3><div>The study was duly recorded in the Chinese Clinical Trial Registry on May 13, 2022 (Registration number: ChiCTR2200059867).</div></div><div><h3>Registration website</h3><div><span><span>https://www.chictr.org.cn/showproj.aspx?proj=162504</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101376"},"PeriodicalIF":1.4,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142572638","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":"Adapting the design of the ongoing RAMPART trial in response to external evidence: An example for trials which take many years to run and report","authors":"Angela Meade ,&nbsp;Elena Frangou ,&nbsp;Babak Choodari-Oskooei ,&nbsp;James Larkin ,&nbsp;Tom Powles ,&nbsp;Grant D. Stewart ,&nbsp;Laurence Albiges ,&nbsp;Axel Bex ,&nbsp;Toni K. Choueiri ,&nbsp;Ian D. Davis ,&nbsp;Tim Eisen ,&nbsp;Alison Fielding ,&nbsp;Craig Gedye ,&nbsp;David J. Harrison ,&nbsp;Rick Kaplan ,&nbsp;Salena Mulhere ,&nbsp;Paul Nathan ,&nbsp;Grisma Patel ,&nbsp;Jay Patel ,&nbsp;Hannah Plant ,&nbsp;Mahesh K.B. Parmar","doi":"10.1016/j.conctc.2024.101381","DOIUrl":"10.1016/j.conctc.2024.101381","url":null,"abstract":"<div><div>Clinical trials to establish the efficacy of new agents in the adjuvant cancer setting typically take many years to complete. During that time, external factors can impact recruitment and reporting plans. An example is a new standard of care becoming available during the recruitment period.</div><div>In this paper we describe how we modified the design of the RAMPART trial (<span><span>NCT03288532</span><svg><path></path></svg></span>) which was set up to investigate immune checkpoint inhibitor therapy in the adjuvant renal cancer setting. The trial had been initiated when no globally accepted adjuvant strategy after nephrectomy existed. A subsequent change in the standard of care for many patients with early renal cancer meant it was no longer feasible to continue to recruit. We needed to find a way to maximise the contribution that RAMPART participants could make to the evidence base for immune checkpoint inhibitor therapy without introducing bias or detriment to the integrity of the trial results. We describe how we agreed and incorporated all design and timeline changes while remaining blinded to accumulating data within the trial, thus protecting the reliability of the future results. We share details of our design modifications to guide others who may have similar experiences, particularly as more agents and combinations of agents are developed and investigated in similar adjuvant settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101381"},"PeriodicalIF":1.4,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561235","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}