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Intellectual Property—Protecting Patents, Trademarks, Copyrights, and Trade Secrets 知识产权保护专利、商标、版权和商业秘密
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-16-4009
B. Ibata
{"title":"Intellectual Property—Protecting Patents, Trademarks, Copyrights, and Trade Secrets","authors":"B. Ibata","doi":"10.14524/CR-16-4009","DOIUrl":"https://doi.org/10.14524/CR-16-4009","url":null,"abstract":"Intellectual property rights balance the incentive for innovative thought and creative expression with the greatest pubic access to the writings and discoveries that result. The form and function of the intellectual property determine the manner and duration that it may be protected. A well-crafted clinical trial agreement protects the intellectual property rights of the parties engaged in the research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"9 1","pages":"73-75"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83786050","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
Challenges and Training Needs for Clinical Research Associates—A Survey 临床研究人员的挑战和培训需求——一项调查
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-15-0039
Niranjan S. Kulkarni, A. Bhatt, J. Dalal
{"title":"Challenges and Training Needs for Clinical Research Associates—A Survey","authors":"Niranjan S. Kulkarni, A. Bhatt, J. Dalal","doi":"10.14524/CR-15-0039","DOIUrl":"https://doi.org/10.14524/CR-15-0039","url":null,"abstract":"The objective of this articls is to understand the perceptions of clinical research associates (CRAs) about the time and effort required for monitoring; their importance in protecting the rights, safety, and well-being of subjects and data integrity; and their expectations about training needs and approaches. To these ends, a survey was conducted among 192 professionals with monitoring experience. Among other findings, the results show that CRAs rated source data verification as the most time-consuming activity, co-monitoring visits are the most preferred approach to learn monitoring, and CRAs need more training to learn to interact with principal investigators. There is a gap between CRAs’ perception of the importance of monitoring activities and the time spent on them.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"1 1","pages":"28-33"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90272680","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
Key Considerations for Social Media Recruitment Platforms 社交媒体招聘平台的关键考虑因素
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-15-0019
Deborah D. Rupert
{"title":"Key Considerations for Social Media Recruitment Platforms","authors":"Deborah D. Rupert","doi":"10.14524/CR-15-0019","DOIUrl":"https://doi.org/10.14524/CR-15-0019","url":null,"abstract":"This article analyzes successful features of social media–based websites in the context of clinical trial recruitment. From the perspective of researchers, the use of social media is thought to enhance efficiency, ease of accessible stats on completed trials, data that better reflect the patient experience, and communication. Patients stand to gain efficient access levels in terms of a website’s navigation and content, privacy controls, information drawn from a wide range of sources, and a portal of communication to clinical trial experts. Examined is how various websites successfully address some of these wish list items, how some institutions have expanded recruitment efforts through electronic platforms, and how these solutions might be extrapolated into a social media–based clinical trials site.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"18 1","pages":"22-27"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84442480","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
What Does the Future of Phase III Clinical Trials Look Like in a Population Health Model 在人口健康模型中，III期临床试验的未来会是什么样子
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-15-0032
K. Aguilar, Erika Shah, Kelly J. Ko
{"title":"What Does the Future of Phase III Clinical Trials Look Like in a Population Health Model","authors":"K. Aguilar, Erika Shah, Kelly J. Ko","doi":"10.14524/CR-15-0032","DOIUrl":"https://doi.org/10.14524/CR-15-0032","url":null,"abstract":"As the population health framework transforms the way clinical care is delivered to individuals and communities, it is expected to influence research agendas and broaden the scope of information available for clinical research. This article provides insight on how the shift toward population health will impact Phase III trials. The findings were derived through an expert panel discussion, involving an evidence review and survey of stakeholders with backgrounds in population health and clinical trials. Overall, there was consensus that the population health framework will have an impact on the future of Phase III clinical trials, and that researchers have an opportunity to incorporate these concepts to evolve the clinical trial model. In particular, there are promising trends related to technology and data.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"72 1","pages":"61-66"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84935807","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
Forty Years in the Making—The Remote Manager 四十年的成就——远程经理
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-16-4011
Martin Robinson
{"title":"Forty Years in the Making—The Remote Manager","authors":"Martin Robinson","doi":"10.14524/CR-16-4011","DOIUrl":"https://doi.org/10.14524/CR-16-4011","url":null,"abstract":"Although technology has changed our expectations out of all recognition, allowing us to communicate pretty much with anyone at any time anywhere in the world, human nature has not evolved in 40 years. As technology has enabled an increasing number of people, including line managers, to work from home, the clinical research enterprise has seen the advent of the remote manager—the advantages and possible disadvantages of which (and how to compensate) are discussed here.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"17 1","pages":"76-77"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74744239","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
Can we Halve the Incidence of Failed Clinical Trials in the Next 10 years 我们能在未来10年将临床试验失败的发生率减半吗
Clinical researcher (Alexandria, Va.) Pub Date : 2016-04-01 DOI: 10.14524/CR-16-4015
C. Heering
{"title":"Can we Halve the Incidence of Failed Clinical Trials in the Next 10 years","authors":"C. Heering","doi":"10.14524/CR-16-4015","DOIUrl":"https://doi.org/10.14524/CR-16-4015","url":null,"abstract":"In much the same way as for the schooling of children, the clinical research industry is shifting to an enhanced approach for process as well as outcome support and verification. Steps are being taken to adopt the wonderful change of include behavioral sciences in clinical research conduct. We are seeing the first results of the shift to a more balanced focus on both outcome and procedure. The end result should be a reduced number of failed clinical trials, and over time, maybe even a halving of failed clinical trials.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"173 1","pages":"55-56"},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79612665","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
Is Your CAPA System Effective 你的CAPA系统有效吗
Clinical researcher (Alexandria, Va.) Pub Date : 2016-02-01 DOI: 10.14524/CR-15-0020
Susan Leister
{"title":"Is Your CAPA System Effective","authors":"Susan Leister","doi":"10.14524/CR-15-0020","DOIUrl":"https://doi.org/10.14524/CR-15-0020","url":null,"abstract":"A corrective and preventive actions (CAPA) system is an essential component of any quality management system, and is an approach intended to correct and prevent problems from recurring or prevent them from ever happening. This article describes key components of a CAPA system, highlights key","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"382 1","pages":"56-57"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76456862","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
New Opportunities and Threats in the Realm of Informed Consent 知情同意领域的新机遇与威胁
Clinical researcher (Alexandria, Va.) Pub Date : 2016-02-01 DOI: 10.14524/CR-16-4005
James Michael Causey
{"title":"New Opportunities and Threats in the Realm of Informed Consent","authors":"James Michael Causey","doi":"10.14524/CR-16-4005","DOIUrl":"https://doi.org/10.14524/CR-16-4005","url":null,"abstract":"Informed consent errors have fallen to sixth from first place as cited in most common clinical investigator findings by the U.S. Food and Drug Administration (FDA) over the past five years. While that suggests clinical researchers and sites have gotten better at handling this critically important","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"21 1","pages":"40-41"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73335348","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
Therapeutic Innovations in Oncology 肿瘤学治疗创新
Clinical researcher (Alexandria, Va.) Pub Date : 2016-02-01 DOI: 10.14524/CR-15-0043
C. Jenkins, G. Demetri
{"title":"Therapeutic Innovations in Oncology","authors":"C. Jenkins, G. Demetri","doi":"10.14524/CR-15-0043","DOIUrl":"https://doi.org/10.14524/CR-15-0043","url":null,"abstract":"While clinical research is often ethically challenging, clinical trials in oncology can bring uniquely difficult ethical considerations. Researchers and study teams have long struggled with the difficulties of conducting research and obtaining truly informed consent in patients who may be driven by","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"70 1","pages":"42-47"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80145662","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
5 Proposals to Ponder in the New Year 新年思考的5个建议
Clinical researcher (Alexandria, Va.) Pub Date : 2016-02-01 DOI: 10.14524/CR-16-4000
M. Hamrell
{"title":"5 Proposals to Ponder in the New Year","authors":"M. Hamrell","doi":"10.14524/CR-16-4000","DOIUrl":"https://doi.org/10.14524/CR-16-4000","url":null,"abstract":"As we head into 2016, clearly there are some significant issues and changes pending and under review regarding the conduct of clinical research following the tenets of good clinical practice.\u0000\u0000As we begin another year and not too many questions have been coming in to answer in the usual Q&A format","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"189 1","pages":"54-55"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83054193","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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