Clinical investigation最新文献

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Anatomy and physiology of translation: the academic research imperative 翻译的解剖学和生理学:学术研究的必要性
Clinical investigation Pub Date : 2015-12-11 DOI: 10.4155/CLI.15.46
G. Apiou-Sbirlea, G. Tearney, R. Birngruber, T. Hasan, R. Anderson
{"title":"Anatomy and physiology of translation: the academic research imperative","authors":"G. Apiou-Sbirlea, G. Tearney, R. Birngruber, T. Hasan, R. Anderson","doi":"10.4155/CLI.15.46","DOIUrl":"https://doi.org/10.4155/CLI.15.46","url":null,"abstract":"The transfer of academic innovation to clinical practice and industry is taking on an increasingly important role in academic centers, but significant challenges remain. This work identifies some of the pivotal elements that are required to assemble, manage and accelerate the pace of successful translational research. These elements can be incorporated in new models of translational research facilitation that improve the process of converting academic innovations to commercial products where they can be used to benefit patient health on a large scale.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"118 1","pages":"797-804"},"PeriodicalIF":0.0,"publicationDate":"2015-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88033015","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}
引用次数: 6
Complications and management of hyperkalemia: implications for the use of the novel cation exchangers zirconium cyclosilicate and patiromer 高钾血症的并发症和处理:新型阳离子交换剂环硅酸锆和聚氰胺使用的意义
Clinical investigation Pub Date : 2015-10-30 DOI: 10.4155/CLI.15.48
L. Noureddine, B. Dixon
{"title":"Complications and management of hyperkalemia: implications for the use of the novel cation exchangers zirconium cyclosilicate and patiromer","authors":"L. Noureddine, B. Dixon","doi":"10.4155/CLI.15.48","DOIUrl":"https://doi.org/10.4155/CLI.15.48","url":null,"abstract":"Hyperkalemia is a serious and common clinical condition associated with increased morbidity and death. The risk of hyperkalemia is increased in patients with chronic kidney disease, diabetes, conditions with impaired distal renal sodium delivery and those on renin–angiotensin–aldosterone system (RAAS) blockade. RAAS blockade has been shown to slow progression of proteinuric kidney disease and reduce mortality in patients with systolic heart failure. Yet delivery of optimum RAAS blockade is frequently limited by development of hyperkalemia. Current treatment for hyperkalemia is suboptimal and few options exist for long-term control of hyperkalemia. In this review article, we explore two new oral nonabsorbable cation exchangers, zirconium cyclosilicate (ZS-9) and patiromer that bind potassium for the treatment of hyperkalemia.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"1 1","pages":"805-823"},"PeriodicalIF":0.0,"publicationDate":"2015-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81529094","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}
引用次数: 5
Solving clinical trial delays: innovative solutions 解决临床试验延误:创新解决方案
Clinical investigation Pub Date : 2015-10-26 DOI: 10.4155/CLI.15.41
Kavita Singh, M. A. Salam, R. Devarajan, D. Prabhakaran
{"title":"Solving clinical trial delays: innovative solutions","authors":"Kavita Singh, M. A. Salam, R. Devarajan, D. Prabhakaran","doi":"10.4155/CLI.15.41","DOIUrl":"https://doi.org/10.4155/CLI.15.41","url":null,"abstract":"Our objective was to provide broad perspective on causes and consequences of clinical trial delays and suggest process-oriented and technology-enabled pragmatic solutions to minimize trial delays, in particular context of doing trials in India. The main challenges for successful completion of clinical trials stem from regulatory and ethics review, investigator selection, site initiations, participant recruitment and retention, monitoring and data management issues. Careful planning, sorting out ownership issues in the initial steps and a partnership based on shared issues among all the stakeholders will help reduce the trial delays. Such a shared vision will enable adherence to regulatory requirements, enhance the quality of trial conduct and ultimately enable improved access to new treatments and its benefits to the Indian population.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"53 1","pages":"745-753"},"PeriodicalIF":0.0,"publicationDate":"2015-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81015295","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}
引用次数: 1
Development of a generic laboratory manual for biological sample logistics in clinical pharmacokinetic studies 开发临床药代动力学研究中生物样品物流的通用实验室手册
Clinical investigation Pub Date : 2015-10-26 DOI: 10.4155/CLI.15.42
R. Abbott, Rebecca Sleigh, J. Long, C. Ekstrom, B. Matthes, José Groenboom-Nieuwenhuijzen
{"title":"Development of a generic laboratory manual for biological sample logistics in clinical pharmacokinetic studies","authors":"R. Abbott, Rebecca Sleigh, J. Long, C. Ekstrom, B. Matthes, José Groenboom-Nieuwenhuijzen","doi":"10.4155/CLI.15.42","DOIUrl":"https://doi.org/10.4155/CLI.15.42","url":null,"abstract":"2015 The European Bioanalysis Forum (EBF) has been organizing ‘Topic Teams’ on issues of importance to the bioanalytical community for several years [1]. Many of these teams focus on internal bioanalytical issues of importance to bioanalysts such as technological innovation, regulatory questions and novel assay validation approaches [2]. However, there is an increasing recognition that we do need to pay more attention to external factors such as interactions and communication regarding clinical, toxicology and project team participation [3]. Topic Team 12, a virtual team of ten EBF member companies and meeting every 2 to 3 weeks by teleconference, focused on topics of interest associated with clinical trial support. Following a member survey and extended team discussion it was felt that the generation of a generic laboratory manual for use in clinical pharmacokinetic studies would offer a potential solution to the common problems created by poor logistical sample management and communication in single and multicentre trials [4]. Such a document would create a single platform to which clinical sites, central laboratories and bioanalytical groups could all relate. The benefits could be significant since a harmonized document should stimulate a consistent way of working and would be a first step in the elimination of many current issues.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"5 1","pages":"741-744"},"PeriodicalIF":0.0,"publicationDate":"2015-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85378647","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}
引用次数: 0
Engaging patients for drug repurposing: mapping the patient engagement continuum 让患者参与药物再利用:绘制患者参与连续体
Clinical investigation Pub Date : 2015-10-26 DOI: 10.4155/CLI.15.39
M. Allarakhia
{"title":"Engaging patients for drug repurposing: mapping the patient engagement continuum","authors":"M. Allarakhia","doi":"10.4155/CLI.15.39","DOIUrl":"https://doi.org/10.4155/CLI.15.39","url":null,"abstract":"Drug repurposing involves finding new indications for existing drugs or potential drug candidates. Drugs or candidates include those in clinical development with relevance to multiple diseases, drugs that have failed to demonstrate efficacy for a particular indication during clinical trials but have no major safety concerns, discontinued drugs, drugs not yet fully pursued and drugs for which patents are set to expire [1]. Opportunities for drug repositioning can arise from indirect observation as well as purposeful collaboration including physician and patient engagement. The focus of this editorial is primarily on the engagement of patients directly or through patient information to support drug repurposing endeavors. Engagement must permit the transition of patients from the role of simple participant to the mid-level informative role, and at the highest level of engagement the collaborative role. Table 1 outlines a newly devised continuum of patient engagement. The focus is on the engagement of the ‘lead patient’ [2]. ‘Lead patients’ – namely those patients that: are proactive with respect to their health, disease and treatment options, can provide a nuanced perspective to drug discovery, including through repurposing endeavors [2]. Specifically, patients can be a source of direct information with respect to off-label drug usage, patient records and patient communities can indirectly reveal drug repurposing opportunities, and patients can jointly collaborate in the search for new drug repurposing opportunities through the deciphering of information on drug pharmacology – system or – gene interaction or other design opportunities [3]. The engagement could not be more salient than for rare disease drug repurposing [4].","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"30 1","pages":"733-737"},"PeriodicalIF":0.0,"publicationDate":"2015-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81635442","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}
引用次数: 2
Pharmacological treatment of left ventricular remodeling: recent trial results 左心室重构的药物治疗:最近的试验结果
Clinical investigation Pub Date : 2015-10-26 DOI: 10.4155/CLI.15.44
A. Tomasik, E. Nowalany-Kozielska
{"title":"Pharmacological treatment of left ventricular remodeling: recent trial results","authors":"A. Tomasik, E. Nowalany-Kozielska","doi":"10.4155/CLI.15.44","DOIUrl":"https://doi.org/10.4155/CLI.15.44","url":null,"abstract":"Ventricular remodeling, recently characterized as an inhomogeneous entity, has quickly become a therapeutic target. It is assumed that prevention of ventricle remodeling would stop the progression of heart failure. In this review we discuss briefly the issue of ventricular remodeling along with underlying mechanisms leading to cardiac hypertrophy and/or dilatation. Furthermore, we discuss the pharmacologic approaches to prevent left ventricle remodeling, either in animal studies or human trials.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"23 1","pages":"767-776"},"PeriodicalIF":0.0,"publicationDate":"2015-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81531081","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}
引用次数: 1
Interview with Graham Clarke 格雷厄姆·克拉克访谈
Clinical investigation Pub Date : 2015-10-26 DOI: 10.4155/CLI.15.40
G. Clarke
{"title":"Interview with Graham Clarke","authors":"G. Clarke","doi":"10.4155/CLI.15.40","DOIUrl":"https://doi.org/10.4155/CLI.15.40","url":null,"abstract":"Dr Graham Clarke is the senior director and head of the respiratory and inflammation unit, Early Clinical Development, at Quintiles, London. He leads the development and execution of inhaler generics and inhaler characterization studies, biomarker identification efforts and the development of challenge models of inflammation across several therapeutic areas. After previous appointments in molecular and forensic analytical biology and subsequently training as a clinical physiologist at the Royal Brompton Hospital, London, UK, Dr Clarke has served in a variety of respiratory clinical research environments. He is an honorary research fellow in cardiothoracic pharmacology at Imperial College London’s National Heart and Lung Institute. Dr Clarke completed a PhD in respiratory pharmacology and physiology with a focus on airway and vascular hyper-responsiveness in asthma at King’s College, London, UK.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"55 1","pages":"739-740"},"PeriodicalIF":0.0,"publicationDate":"2015-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82293134","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}
引用次数: 0
Apremilast in the treatment of moderate-to-severe plaque psoriasis: results from the ESTEEM studies 阿普拉米司特治疗中重度斑块型银屑病:来自ESTEEM研究的结果
Clinical investigation Pub Date : 2015-10-06 DOI: 10.4155/CLI.15.50
J. Cather, Elizabeth J Horn
{"title":"Apremilast in the treatment of moderate-to-severe plaque psoriasis: results from the ESTEEM studies","authors":"J. Cather, Elizabeth J Horn","doi":"10.4155/CLI.15.50","DOIUrl":"https://doi.org/10.4155/CLI.15.50","url":null,"abstract":"Psoriasis is a chronic, systemic inflammatory disease that often has a negative impact on daily functioning and quality of life. Although many treatment options are available, patients are often dissatisfied with their current disease management. Apremilast, an oral PDE4 inhibitor, was recently approved in multiple countries for the treatment of patients with active psoriatic arthritis and patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In Phase III pivotal clinical trials, apremilast demonstrated clinical efficacy and safety in the treatment of psoriasis as well as active psoriatic arthritis. Here, we discuss the clinical implications and future direction of psoriasis therapy, given the availability of a new oral treatment option.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"30 1","pages":"777-791"},"PeriodicalIF":0.0,"publicationDate":"2015-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82311410","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}
引用次数: 2
There should be only one priority in clinical research – to put the needs of the consumer first 在临床研究中应该只有一个优先事项——把消费者的需求放在第一位
Clinical investigation Pub Date : 2015-09-18 DOI: 10.4155/cli.15.32
S. Denegri
{"title":"There should be only one priority in clinical research – to put the needs of the consumer first","authors":"S. Denegri","doi":"10.4155/cli.15.32","DOIUrl":"https://doi.org/10.4155/cli.15.32","url":null,"abstract":"","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"423 1","pages":"677-679"},"PeriodicalIF":0.0,"publicationDate":"2015-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84935680","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}
引用次数: 0
Missing Data in Clinical Trials Forum 临床试验论坛缺失数据
Clinical investigation Pub Date : 2015-09-18 DOI: 10.4155/CLI.15.35
T. Katz
{"title":"Missing Data in Clinical Trials Forum","authors":"T. Katz","doi":"10.4155/CLI.15.35","DOIUrl":"https://doi.org/10.4155/CLI.15.35","url":null,"abstract":"Missing Data in Clinical Trials Forum Loews Philadelphia Hotel, Philadelphia, PA, USA, 16–17 March 2015 Missing data, defined as values not available that would have been meaningful for analysis if they were observed, are commonplace in academic, government and industry run clinical trials. However, this data loss can result in an inadequate basis for study inferences. In 2014, multiple US FDA advisory committees challenged the quantity of missing data and the conclusions drawn from their study outcomes, resulting in approval delays or rejection of product registration. The Missing Data in Clinical Trials Forum invited experts from academia, government and industry to explore methods to avoid missing data by design, and present on tools to detect and rectify missing data during the trial. Statistical methodology to impute or model data missing at random, or not at random, was also discussed.","PeriodicalId":10369,"journal":{"name":"Clinical investigation","volume":"32 1","pages":"681-685"},"PeriodicalIF":0.0,"publicationDate":"2015-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85614423","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}
引用次数: 4
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