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OPINION: What Do the U.S. Election Results Mean to the Clinical Trials Industry? 观点:美国大选结果对临床试验行业意味着什么?
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4053]
D. Vulcano
{"title":"OPINION: What Do the U.S. Election Results Mean to the Clinical Trials Industry?","authors":"D. Vulcano","doi":"10.14524/CR-16-4053]","DOIUrl":"https://doi.org/10.14524/CR-16-4053]","url":null,"abstract":"Undoubtedly, the actions and inactions of the U.S. Congress have direct and indirect effects on the clinical trials industry. Also undoubtedly, anxiety is heightened at times after elections, especially when they result in changes of the administration. In this opinion piece, the author says that the change in leadership represented by the incoming Donald Trump administration calls into question the longevity of the Patient Protection and Affordable Care Act, and analyzes what goes away in the event of its repeal and/or defunding.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"43 1","pages":"30-33"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73042697","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
Visiting the Urgency Room 拜访急症室
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4054
Ronald S. Waife
{"title":"Visiting the Urgency Room","authors":"Ronald S. Waife","doi":"10.14524/CR-16-4054","DOIUrl":"https://doi.org/10.14524/CR-16-4054","url":null,"abstract":"While common enough in small, entrepreneurial companies, any sense of speed, focus, and anxiety is rarely found in Big Pharma. Where is the sense of urgency in clinical development?","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"29 1","pages":"40-41"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73270807","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
Standards Key to Preparing for the Evolving Trials Landscape 标准是为不断变化的试验环境做准备的关键
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4051
J. Kremidas
{"title":"Standards Key to Preparing for the Evolving Trials Landscape","authors":"J. Kremidas","doi":"10.14524/CR-16-4051","DOIUrl":"https://doi.org/10.14524/CR-16-4051","url":null,"abstract":"ACRP’s Executive Director says there’s no replacement for getting out in the field and interacting directly with clinical trial professionals, and explains how ACRP has been working to help identify and codify the kills and experiences that make for an excellent clinical trial practitioner.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"11 1","pages":"7-7"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88734649","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
Project Managers Influence Parallel Planning and Collaboration Between Sites and Sponsors 项目经理影响平行规划和协作之间的网站和赞助商
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-0005
Romiya Barry, J. Coffie, Catherine P. Y. Mok, J. Chapman
{"title":"Project Managers Influence Parallel Planning and Collaboration Between Sites and Sponsors","authors":"Romiya Barry, J. Coffie, Catherine P. Y. Mok, J. Chapman","doi":"10.14524/CR-16-0005","DOIUrl":"https://doi.org/10.14524/CR-16-0005","url":null,"abstract":"Clinical research is a dynamic field, with changes in regulatory requirements, market demands, and clinical practice affecting clinical project design and study timing. It is critical that studies are conceptualized, initialized, and reported efficiently. Leadership and good clinical trial management at both the sponsor and site levels are essential to the delivery of high-quality trials. A few guiding principles for early engagement can set the tone for collaboration in the project. A successful clinical trial project manager has the ability to work effectively with stakeholders to define the clinical program requirements, shape the output of projects, and drive successful study outcomes.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"84 1","pages":"12-15"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90946899","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
The Necessity of Workforce Development for Clinical Research Professionals 临床研究专业人才队伍建设的必要性
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4047
P. Smailes
{"title":"The Necessity of Workforce Development for Clinical Research Professionals","authors":"P. Smailes","doi":"10.14524/CR-16-4047","DOIUrl":"https://doi.org/10.14524/CR-16-4047","url":null,"abstract":"A skilled workforce is essential, and the only way it can be accomplished is through education and ongoing professional development. In an effort to bring new ideas on clinical workforce development to our readers, this issue of Clinical Researcher addresses the topic from multiple angles for a wide array of clinical research roles.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"47 1","pages":"4-4"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82226220","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
Be a Part of Our Bright Future 成为我们美好未来的一部分
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4052
S. Ziemba
{"title":"Be a Part of Our Bright Future","authors":"S. Ziemba","doi":"10.14524/CR-16-4052","DOIUrl":"https://doi.org/10.14524/CR-16-4052","url":null,"abstract":"The 2016 Chair of ACRP’s Association Board of Trustees shares some final thoughts with readers about the time he served in the role, as well as about how others can participate in the future of the organization through volunteerism.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"309 1","pages":"6-6"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74079259","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
Building an Internal Quality Assurance Program 建立内部质量保证程序
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-0019
S. Niranjan
{"title":"Building an Internal Quality Assurance Program","authors":"S. Niranjan","doi":"10.14524/CR-16-0019","DOIUrl":"https://doi.org/10.14524/CR-16-0019","url":null,"abstract":"Any academic medical center nurturing a research program must take practical steps to safeguard compliance. Instead of relying solely on pharmaceutical monitoring to preserve compliance, the establishment of an internal quality assurance (QA) system may be considered as an extra step toward meeting compliance goals. Commitment from upper levels of management can set up the audit program to be a key element of a Good Clinical Practice quality system within an organization. If internal QA is viewed as an essential, cohesive element of research programs, it would nurture constructive interactions between the research team and QA professional, thereby building higher standards of quality into the program.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"60 1","pages":"52-53"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74576982","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
Risk-Based Monitoring 基于风险的监控
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-15-0047
V. Halbe, J. Dalal
{"title":"Risk-Based Monitoring","authors":"V. Halbe, J. Dalal","doi":"10.14524/CR-15-0047","DOIUrl":"https://doi.org/10.14524/CR-15-0047","url":null,"abstract":"Risk-based monitoring is a model for monitoring that improves quality, efficiency, and compliance in clinical trials. Adoption of any new concept is followed with a change in roles and, to a greater extent, in the mindset of a user. This article discusses various changes that different stakeholders may need to accept if the evolution of risk-based monitoring is to be successful.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"12 1","pages":"16-19"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74747240","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
Global Self-Assessment of Competencies, Role Relevance, and Training Needs Among Clinical Research Professionals 临床研究专业人员能力、角色相关性和培训需求的全球自我评估
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-0016
S. Sonstein, Honorio Silva, C. Jones, Nancy A. Calvin-Naylor, Laurie A. Halloran, J. L. Yrivarren
{"title":"Global Self-Assessment of Competencies, Role Relevance, and Training Needs Among Clinical Research Professionals","authors":"S. Sonstein, Honorio Silva, C. Jones, Nancy A. Calvin-Naylor, Laurie A. Halloran, J. L. Yrivarren","doi":"10.14524/CR-16-0016","DOIUrl":"https://doi.org/10.14524/CR-16-0016","url":null,"abstract":"The Joint Task Force for Clinical Trial Competency conducted a multinational survey of clinical research professionals as a first step toward validating its previously published framework. Participants self-assessed their competence level and the relevance of specific core competencies to their current professional activities, as well as their perceived need for further training to enhance performance quality. Significant differences in the perception of competence and relevance for the role were observed among the various members of the clinical research team.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"26 1","pages":"42-49"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88755019","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: 15
Clinical Technology Designed to Unite 临床技术旨在团结
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4049
J. Johnston
{"title":"Clinical Technology Designed to Unite","authors":"J. Johnston","doi":"10.14524/CR-16-4049","DOIUrl":"https://doi.org/10.14524/CR-16-4049","url":null,"abstract":"As clinical trials go global and companies continue to outsource critical functions, technology becomes more important in optimizing stakeholder communications and data management processes throughout the drug development lifecycle.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"17 1","pages":"50-51"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87211891","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
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