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Utilizing Cultural Humility as a Tool to Support Diversity in Clinical Research. 利用文化谦逊作为支持临床研究多样性的工具。
Clinical researcher (Alexandria, Va.) Pub Date : 2024-02-01
Jessica Fritter, Bashar Shihabuddin
{"title":"Utilizing Cultural Humility as a Tool to Support Diversity in Clinical Research.","authors":"Jessica Fritter, Bashar Shihabuddin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As applied to the clinical research enterprise, \"cultural humility\" is a continuous process of self-orientation toward caring for others based on self-reflection and assessment, appreciation of others' experiences, and expertise on the social and cultural context of their lives, with an openness to establishing strong relationships within the research team and with study subjects. Applying cultural humility training to a clinical research infrastructure provides open awareness of biases, privileges, and the limitations of one's own knowledge. These insights may enhance one's approaches to interactions with potential subjects during recruitment and with actual subjects during study conduct while complementing existing cultural competency training and, in turn, supporting diversity among team members and research subjects.</p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"38 1","pages":"9-12"},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11709128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mapping the Pathway to Take Control of Your Clinical Research Career. 绘制掌控临床研究事业的路线图。
Clinical researcher (Alexandria, Va.) Pub Date : 2023-10-01 Epub Date: 2023-10-17
Jessica Fritter, Carolynn Jones
{"title":"Mapping the Pathway to Take Control of Your Clinical Research Career.","authors":"Jessica Fritter, Carolynn Jones","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"37 5","pages":"7-15"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11172395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141319202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perspectives on Successes and Challenges in the Recruitment and Retention of Pregnant Women in a Research Study. 在一项研究中对孕妇招募和保留的成功和挑战的看法。
Clinical researcher (Alexandria, Va.) Pub Date : 2019-09-01 Epub Date: 2019-09-19
Amy Rider, Christine Aubry, Sara Moyer, Patricia Kinser
{"title":"Perspectives on Successes and Challenges in the Recruitment and Retention of Pregnant Women in a Research Study.","authors":"Amy Rider,&nbsp;Christine Aubry,&nbsp;Sara Moyer,&nbsp;Patricia Kinser","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"33 8","pages":"6-14"},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7440001/pdf/nihms-1568304.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38296281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Survey on Including Risks in the New "Key Information" Section of an Informed Consent Form. 关于将风险纳入知情同意书新的 "关键信息 "部分的调查。
Clinical researcher (Alexandria, Va.) Pub Date : 2018-12-01
Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller
{"title":"A Survey on Including Risks in the New \"Key Information\" Section of an Informed Consent Form.","authors":"Katelyn Le, Stacy Kopka, Doreen Chaitt, Jerome Pierson, Martha Nason, Tracey Miller","doi":"","DOIUrl":"","url":null,"abstract":"<p><p></p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"32 10","pages":"18-29"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6375502/pdf/nihms-1003031.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36568870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
African American Screening and Enrollment in (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III) CLEAR III. 非裔美国人的筛选和登记(血块溶解:评估脑室内出血的加速解决III)
Clinical researcher (Alexandria, Va.) Pub Date : 2018-08-01 Epub Date: 2018-08-14
Karen Lane, Maningbe Keita, Radhika Avadhani, Rachel Dlugash, Steven Mayo, Richard E Thompson, Issam Awad, Nichol McBee, Wendy Ziai, Daniel F Hanley
{"title":"African American Screening and Enrollment in (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III) CLEAR III.","authors":"Karen Lane,&nbsp;Maningbe Keita,&nbsp;Radhika Avadhani,&nbsp;Rachel Dlugash,&nbsp;Steven Mayo,&nbsp;Richard E Thompson,&nbsp;Issam Awad,&nbsp;Nichol McBee,&nbsp;Wendy Ziai,&nbsp;Daniel F Hanley","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Under-enrolling minority patients in clinical trials reduces generalizability. CLEAR III, a randomized controlled trial, presented an opportunity to assess African American (AA) participation.</p><p><strong>Methods: </strong>AA enrollment was compared to U.S. population and NINDS trial data then stratified by region; census data for 42 recruitment cities were compared to screening and randomization percentages, using simple linear regression.</p><p><strong>Results: </strong>AAs were 25% of screens and 45.1% of enrollments (n=370), more than twice the 19.8% participation rate reported by the 2011 NINDS Advisory Panel on Health Disparities Research and triple the projected 13.9% 2014 U.S. population. Conversion rates were (AA vs. non-AA): overall (8.7% vs. 3.4%, p<0.001); Northeast (7.7% vs. 2.9%, p<0.001); South (8.2% vs. 4.0%, p<0.001); Midwest (10.3% vs. 3.6%, p<0.01); and West (8.9% vs. 3.8%, p=0.02). AA enrollments ranged from 0% to 100% (mean: 40.4%). AA screening ranged from 0% to 63.7% (mean: 23.2%). AA city census ranged from 1.3% to 82.7% (mean: 28.0%); higher census was associated with higher screening (p<0.0001) and enrollment (p=0.004).</p><p><strong>Conclusions: </strong>AAs were willing to enroll in an acute stroke trial. AA city census rates should be considered when selecting enrollment centers and setting recruitment goals. Factors leading to successful AA recruitment should be further investigated, as population-based participation is a goal in all trials.</p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"32 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6138411/pdf/nihms982377.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36497000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ensuring Representativeness in Competencies for Research Coordinators. 确保研究协调员能力的代表性。
Clinical researcher (Alexandria, Va.) Pub Date : 2018-05-01 Epub Date: 2018-05-15
Lauren B Solberg, H Robert Kolb, Alena Prikhidko, Linda S Behar-Horenstein
{"title":"Ensuring Representativeness in Competencies for Research Coordinators.","authors":"Lauren B Solberg,&nbsp;H Robert Kolb,&nbsp;Alena Prikhidko,&nbsp;Linda S Behar-Horenstein","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Providing educational programs designed to promote clinical research coordinators' (CRCs') implementation of competency skills is essential to workforce development; however, little is known about how programs address CRCs' needs. The purpose of this study was to assess CRCs' experiences in a six-month course. Using focus group methods, six participants revealed how the training assisted them in daily work. The findings supported previous study results, and led to the identification of two competencies which are missing from the existing Joint Task Force for Clinical Trial Competency framework domains of \"Communication and Teamwork\" and \"Leadership and Professionalism.\" The authors explain why these competencies are important for coordinators. The authors also discuss the instrumentality of qualitative research to ensure that competency domains reflect the needs of those for whom they are developed.</p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"32 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6138413/pdf/nihms977996.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41143166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Providing Restricted Access to an Electronic Medical Record for Research Monitoring. 为研究监测提供对电子病历的限制访问。
Clinical researcher (Alexandria, Va.) Pub Date : 2018-01-01 Epub Date: 2018-03-13
Leslie Bell, Stephanie Gentilin, Susan Sonne, Toni Mauney, Patrick Flume
{"title":"Providing Restricted Access to an Electronic Medical Record for Research Monitoring.","authors":"Leslie Bell,&nbsp;Stephanie Gentilin,&nbsp;Susan Sonne,&nbsp;Toni Mauney,&nbsp;Patrick Flume","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As hospital systems and healthcare institutions adopt electronic medical records (EMRs), this creates a new challenge in the normal conduct of clinical research. When protected health information (PHI) is stored in an EMR, there is inherent risk that general access to these systems for source verification purposes could allow research monitors to also have access to the PHI of non-study participants.</p>","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"32 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6317372/pdf/nihms-991384.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36839537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Academic Preparation in Clinical Research 临床研究的学术准备
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-0020
C. Jones, J. Benner, Kathryn L. Jelinek, R. Brouwer, B. Casey, J. Lanter, M. Neidecker
{"title":"Academic Preparation in Clinical Research","authors":"C. Jones, J. Benner, Kathryn L. Jelinek, R. Brouwer, B. Casey, J. Lanter, M. Neidecker","doi":"10.14524/CR-16-0020","DOIUrl":"https://doi.org/10.14524/CR-16-0020","url":null,"abstract":"Academic programs offering formal coursework or degrees in clinical research have increased in number over the past decade. As roles in the field of clinical research evolve, and as job titles and descriptions become standardized and professionalized, having an academic pathway to expand knowledge, skills, and abilities better prepares individuals for certification and career advancement. At this juncture in the clinical research enterprise, where the complexity of new medical product development is rapidly escalating, having a well-educated cadre of professionals is important to plan, implement, and evaluate research projects leading to innovative new treatments or diagnostics.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"136 21","pages":"34-39"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72370291","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
Workforce Development for Clinical Research Associates 临床研究助理的劳动力发展
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-0021
Nicole Tesar
{"title":"Workforce Development for Clinical Research Associates","authors":"Nicole Tesar","doi":"10.14524/CR-16-0021","DOIUrl":"https://doi.org/10.14524/CR-16-0021","url":null,"abstract":"One of the greatest challenges in the clinical research enterprise today is ensuring that a competent workforce is available to carry out its activities. The purpose of this article is to discuss how professionals can break into the clinical research associates (CRA) role, and to present models that can help transition the novice into an expert. CRAs and employers need to ensure that an appropriate career path exists with ongoing development opportunities. The Joint Task Force for Clinical Trial Competency has outlined competencies for the clinical research professional that can be translated into the CRA role and serve as the ultimate goal for professional development. By creating a workforce development program that addresses the challenges of CRAs with varying levels of experience, the end result is a qualified and skilled role that is vital to the clinical research industry.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"365 1","pages":"20-23"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80333149","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 Mysterious and Sometimes Maddening 神秘的，有时令人发狂
Clinical researcher (Alexandria, Va.) Pub Date : 2016-12-01 DOI: 10.14524/CR-16-4046
M. Hamrell
{"title":"The Mysterious and Sometimes Maddening","authors":"M. Hamrell","doi":"10.14524/CR-16-4046","DOIUrl":"https://doi.org/10.14524/CR-16-4046","url":null,"abstract":"This issue’s column considers several questions raised by the use of the U.S. Food and Drug Administration (FDA) Form 1572, otherwise known as the “Statement of Investigator” form.","PeriodicalId":90809,"journal":{"name":"Clinical researcher (Alexandria, Va.)","volume":"15 1","pages":"55-56"},"PeriodicalIF":0.0,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81690304","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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