{"title":"The Ethics of Targeted Oncological Trials","authors":"C. Nardini","doi":"10.14524/CR-15-0044","DOIUrl":"https://doi.org/10.14524/CR-15-0044","url":null,"abstract":"In the wake of the full sequencing of the human genome, great promise has been stirred around the prospect of “personalized” or “precision” medicine. This term denotes a collection of techniques that combine various “omics” data—genomics, proteomics, metabolomics, and the like—in","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"124 1","pages":"22-25"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77456055","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":"Proposed Revisions to the Informed Consent and IRB Regulations","authors":"D. Forster, David A. Borasky","doi":"10.14524/CR-15-0041","DOIUrl":"https://doi.org/10.14524/CR-15-0041","url":null,"abstract":"In September 2015, the U.S. Department of Health and Human Services (HHS) released a Notice of Proposed Rulemaking (NPRM) to significantly revise the human subject protection and informed consent regulations known as the “Common Rule.”[1][1] If enacted, it will be the first substantial change to","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"25 1","pages":"14-18"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78735739","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":"Hospital Approval—Non-Delegable Obligations of a Covered Entity","authors":"B. Ibata","doi":"10.14524/CR-16-4001","DOIUrl":"https://doi.org/10.14524/CR-16-4001","url":null,"abstract":"Non-academic hospitals knowingly and unknowingly engage in clinical research every day, and these hospitals have non-transferable obligations, particularly when the research has been reviewed and approved by an external institutional review board (IRB).\u0000\u0000These studies utilize a wide gamut of","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"133 1","pages":"8-10"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78460044","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":"[OPINION] Serious Adverse Events","authors":"M. Noss","doi":"10.14524/CR-15-0036","DOIUrl":"https://doi.org/10.14524/CR-15-0036","url":null,"abstract":"I had a 44-year-old subject in a clinical trial in which I was the principal investigator (PI) call our office and leave a message informing us she experienced a stroke several weeks earlier that almost killed her. She said that she had been previously healthy, and indeed, the only thing she told us","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"9 1","pages":"50-53"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89054404","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":"Designing Clinical Trials for New Drugs","authors":"Jennifer E. Miller, A. Caplan, A. Blasimme","doi":"10.14524/CR-15-0045","DOIUrl":"https://doi.org/10.14524/CR-15-0045","url":null,"abstract":"Much has been written about the ethics of healthcare innovation and the role of pharmaceutical companies in innovation. Rightly or wrongly, the scholarship and media coverage has been disparaging. Many commentators fear that the biopharmaceutical sector no longer serves patients’ interests; they","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"13 1","pages":"34-39"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81754373","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":"Grant Gorr reflects on a decade of experience as a top talent recruiter and president of the ACRP Kansas City Chapter","authors":"J. Meseke","doi":"10.14524/CR-16-4003","DOIUrl":"https://doi.org/10.14524/CR-16-4003","url":null,"abstract":"![Figure][1] \u0000\u0000How did you first become interested in clinical research, and can you describe the career path you’ve followed?\u0000\u0000I first became interested in clinical research in 2005. I work in business development for Aerotek, a company that focuses on clinical research staffing, and it had","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"70 1","pages":"48-49"},"PeriodicalIF":0.0,"publicationDate":"2016-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85692788","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":"Leadership Practices of Clinical Trials Office Leaders in Academic Medical Centers","authors":"Diana D. Naser","doi":"10.14524/CR-15-0012","DOIUrl":"https://doi.org/10.14524/CR-15-0012","url":null,"abstract":"Academic medical centers (AMCs) play a significant role in society as center staff and leadership fulfill their commitment to advancing research, promoting education, and improving patient care.[1][1] AMCs also promote a culture of discovery, which drives missions of treating and eliminating","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"4 1","pages":"39-43"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81289066","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 Overview of Clinical Research in Indonesia","authors":"Umakanta Sahoo, D. Wibowo","doi":"10.14524/CR-15-0001","DOIUrl":"https://doi.org/10.14524/CR-15-0001","url":null,"abstract":"Indonesia, the fourth most populous nation in the world, is an archipelago with more than 17,000 islands and a coastline stretching 54,720 kilometers. Indonesia’s 2013 population was estimated at more than 249 million, and its gross domestic product per capita at US $4,700. The official and major","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"16 1","pages":"64-68"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82070514","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":"Business Association Agreements","authors":"B. Ibata","doi":"10.14524/CR-15-4093","DOIUrl":"https://doi.org/10.14524/CR-15-4093","url":null,"abstract":"A covered entity must have a written agreement with a business associate to share protected health information (PHI). A business associate agreement is not required for a covered entity to disclose PHI to a researcher, provided that the covered entity obtains documentation that the research has been","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"28 2 1","pages":"44-46"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77381343","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":"How to Enter the Clinical Research Field","authors":"J. Frestedt, A. Kablinger, P. Smailes","doi":"10.14524/CR-14-0058","DOIUrl":"https://doi.org/10.14524/CR-14-0058","url":null,"abstract":"This article was written in response to the large numbers of people attending free “How to Enter the Clinical Research Field” webinars offered by the Association of Clinical Research Professionals (ACRP) in 2012[1][1] and more recently on September 5, 2014. The vast interest in this program","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"60 1","pages":"52-57"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84694643","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}