{"title":"Managing Editor’s Message: The October Surprise, Right on Schedule","authors":"G. Cramer","doi":"10.14524/CR-16-4045","DOIUrl":"https://doi.org/10.14524/CR-16-4045","url":null,"abstract":"Anyone who works on a particular publication long enough can certainly fall into some comfortable routines that make the birth pangs of each issue easier to bear. For example, using the October issue of ACRP’s journal as a bit of breathing space in between themed issues, giving the editors a chance to “clear the pipeline” of miscellaneous articles that had come in out of the blue.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"4 1","pages":"3-3"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81013847","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}
{"title":"Getting the Right Signatures on Informed Consent Documents","authors":"Lindsay McNair, Patience Stevens, Glenn Veit","doi":"10.14524/CR-16-0018","DOIUrl":"https://doi.org/10.14524/CR-16-0018","url":null,"abstract":"Obtaining informed consent in clinical research is straightforward when the study population includes capable adults, but becomes complex when certain participants require either legally authorized representatives (LARs) or impartial witnesses. This article discusses situations in which LARs and witnesses should participate in the consent process, the regulatory basis of why these issues are scrutinized so closely, and how the study documents can facilitate protocol review.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"10 1","pages":"22-27"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81656510","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}
{"title":"PI Corner: The Upside of Intervention in a World Full of Constraints","authors":"J. Kingsley","doi":"10.14524/CR-16-4037","DOIUrl":"https://doi.org/10.14524/CR-16-4037","url":null,"abstract":"Let’s talk about the talent in our organizations. Do we always have a full complement of adequately trained talent on our research teams? The author of this column can guarantee you the answer is “no.” Let’s also talk about keeping our sites up to speed in terms of our quality assurance (QA) processes. In the author’s experience, most sites really have no QA process at all.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"103 1","pages":"14-15"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86629677","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}
{"title":"On the Job: Bridging the Clinical Research Divide","authors":"Z. Tedla","doi":"10.14524/CR-16-4040","DOIUrl":"https://doi.org/10.14524/CR-16-4040","url":null,"abstract":"In this column, an author who has seen both sides considers the different perspectives that investigators and monitors have in conducting clinical research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"86 1","pages":"56-58"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73176569","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}
{"title":"Academia, Investigator-Initiated Research, and a Unique Resource to Support Both","authors":"L. Lutherer, Cathy Lovett","doi":"10.14524/CR-16-0009","DOIUrl":"https://doi.org/10.14524/CR-16-0009","url":null,"abstract":"Scholarly activity is an important expectation of an academic institution, and the requirements for it as part of the education and training of medical students and residents continue to increase. Investigator-initiated research is a major component of scholarly activity. However, clinical faculty have little or no protected time for research. The administration at the Texas Tech University Health Sciences Center addressed this problem with a unique approach by creating an institute to support faculty research.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"67 1","pages":"38-43"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76517099","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}
{"title":"An Insider’s Perspective on FDA’s “Year of Diversity in Clinical Trials”","authors":"James Michael Causey","doi":"10.14524/CR-16-4042","DOIUrl":"https://doi.org/10.14524/CR-16-4042","url":null,"abstract":"The Food and Drug Administration (FDA) has declared 2016 to be the “Year of Diversity in Clinical Trials.” However, that effort won’t end when the calendar page flips to January 2017. Dr. Jonca Bull, MD, the first permanent director of FDA’s Office of Minority Health, recently spoke with Clinical Researcher about the initiative and her office’s mission.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"32 1","pages":"48-49"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75591438","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}
{"title":"Chair’s Message","authors":"S. Ziemba","doi":"10.14524/CR-16-4032","DOIUrl":"https://doi.org/10.14524/CR-16-4032","url":null,"abstract":"We are living in an exciting time in the field of clinical research. There are changes occurring that will alter how medical care is provided, and it is the work of clinical research professionals that will lead these changes. In this column, the Chair of ACRP’s Association Board of Trustees considers the impact of genetics in medicine and their application through precision medicine.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"14 1","pages":"8-8"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82352559","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}
{"title":"Industry Embraces Precision Clinical Trials","authors":"James Michael Causey","doi":"10.14524/CR-16-4031","DOIUrl":"https://doi.org/10.14524/CR-16-4031","url":null,"abstract":"In this article, Clinical Researcher ’s editor-in-chief presents insights from a variety of experts on how the adoption of precision clinical trials and the pursuit of personalized medicines are ascendant and inextricably linked, and how neither shows any signs of losing altitude any time soon.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"200 1","pages":"56-57"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83540681","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}
{"title":"Prozac Author Calls for Reassessment of Clinical Trial Efficacy","authors":"James Michael Causey","doi":"10.14524/CR-16-4029","DOIUrl":"https://doi.org/10.14524/CR-16-4029","url":null,"abstract":"Clinical Researcher ’s editor-in-chief interviews Peter Kramer, author of the controversial Listening to Prozac , about his new book, Ordinarily Well: The Case for Antidepressants , in which the psychiatrist and Brown Medical School professor challenges some current thinking regarding the testing and efficacy of antidepressants.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"26 1","pages":"9-9"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90800237","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}
{"title":"Advances in Clinical Research Toward the Data-Driven Economy","authors":"U. Topaloglu, R. Niedner","doi":"10.14524/CR-16-0008","DOIUrl":"https://doi.org/10.14524/CR-16-0008","url":null,"abstract":"This article highlights how new ubiquitous, participatory, and fast-paced technology trends impact the clinical research enterprise. Social networks, mobile devices, new computing paradigms, and interoperability standards help to democratize clinical research, offer benefits for participant recruitment efforts, and enable high-quality data collection. Such developments have also pushed the demand for multidimensional data analytics, and for secure computing infrastructures capable of scaling up to address the ever-changing requirements and availability of unprecedented amounts and diversity of clinical research data.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"51 1","pages":"58-62"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90897146","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}
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