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Comparing the Clinical Trial Characteristics of Industry-Funded Trials and Non Industry-Funded Trials. 比较行业资助试验和非行业资助试验的临床试验特征。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2024-12-16 DOI: 10.1017/jme.2024.135
Emily Hughes, Tamara Van Bakel, Ashley Raudanskis, Prachi Ray, Benazir Hodzic-Santor, Ushma Purohit, Chana A Sacks, Michael Fralick
{"title":"Comparing the Clinical Trial Characteristics of Industry-Funded Trials and Non Industry-Funded Trials.","authors":"Emily Hughes, Tamara Van Bakel, Ashley Raudanskis, Prachi Ray, Benazir Hodzic-Santor, Ushma Purohit, Chana A Sacks, Michael Fralick","doi":"10.1017/jme.2024.135","DOIUrl":"10.1017/jme.2024.135","url":null,"abstract":"<p><p>We compared study characteristics of randomized controlled trials funded by industry (N=697) to those not funded by industry (N=835). RCTs published in high-impact journals are more likely to be blinded, more likely to include a placebo, and more likely to post trial results on ClinicalTrials.gov. Our findings emphasize the importance of evaluating the quality of an RCT based on its methodological rigor, not its funder type.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 3","pages":"693-700"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142830725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US. 重新利用的监管路线图：欧盟、英国和美国重新利用药物的途径比较
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI: 10.1017/jme.2024.171
Mirre Scholte, Liam Bendicksen, Sabine E Grimm, Teebah Abu-Zahra, Bianca Pauly, Manuela Joore, Aaron S Kesselheim
{"title":"A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.","authors":"Mirre Scholte, Liam Bendicksen, Sabine E Grimm, Teebah Abu-Zahra, Bianca Pauly, Manuela Joore, Aaron S Kesselheim","doi":"10.1017/jme.2024.171","DOIUrl":"10.1017/jme.2024.171","url":null,"abstract":"<p><p>To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 4","pages":"940-949"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
INTRODUCTION: Revolutionizing Neuroimaging Research with Highly Portable MRI: Confronting Ethical and Legal Challenges. 简介：革命性的神经成像研究与高度便携式MRI：面对伦理和法律的挑战。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI: 10.1017/jme.2024.161
Francis X Shen, Frances Lawrenz, Susan M Wolf
{"title":"INTRODUCTION: Revolutionizing Neuroimaging Research with Highly Portable MRI: Confronting Ethical and Legal Challenges.","authors":"Francis X Shen, Frances Lawrenz, Susan M Wolf","doi":"10.1017/jme.2024.161","DOIUrl":"https://doi.org/10.1017/jme.2024.161","url":null,"abstract":"","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 4","pages":"764-768"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Portable Accessible MRI in Dementia Research: Ethical Considerations About Research Representation and Dementia-Friendly Technology. 便携可及MRI在痴呆研究：关于研究代表性和痴呆友好技术的伦理考虑。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI: 10.1017/jme.2024.157
Eran Klein, S Duke Han, Paul Tuite, W Taylor Kimberly, Mohit Agarwal
{"title":"Portable Accessible MRI in Dementia Research: Ethical Considerations About Research Representation and Dementia-Friendly Technology.","authors":"Eran Klein, S Duke Han, Paul Tuite, W Taylor Kimberly, Mohit Agarwal","doi":"10.1017/jme.2024.157","DOIUrl":"10.1017/jme.2024.157","url":null,"abstract":"<p><p>The introduction of portable MRI (pMRI) has the potential to directly impact dementia research and ultimately clinical care. In this paper, we explore two ethical challenges facing the introduction of pMRI in dementia research. The first is the need to ensure that pMRI enhances rather than undermines efforts aimed at improving ethnoracial representation in dementia research. The second is the need to implement pMRI in dementia research in a dementia-friendly way that attends to the social context and lived experience of people with dementia.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 4","pages":"830-839"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expert Stakeholder Perspectives on Emerging Technology for Neuroimaging Research with Highly Portable MRI: The Need for Guidance on Ethical, Legal, and Societal Issues. 专家利益相关者对高度便携式MRI神经成像研究新兴技术的看法：需要伦理、法律和社会问题的指导。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI: 10.1017/jme.2024.160
Molly K Madzelan, Frances Lawrenz, Susan M Wolf, Francis X Shen
{"title":"Expert Stakeholder Perspectives on Emerging Technology for Neuroimaging Research with Highly Portable MRI: The Need for Guidance on Ethical, Legal, and Societal Issues.","authors":"Molly K Madzelan, Frances Lawrenz, Susan M Wolf, Francis X Shen","doi":"10.1017/jme.2024.160","DOIUrl":"10.1017/jme.2024.160","url":null,"abstract":"<p><p>Portable MRI (pMRI) technology, which promises to transform brain imaging research by facilitating scanning in new geographic areas and the participation of new, diverse populations, raises many ethical, legal, and societal issues (ELSI). To understand this emerging pMRI ELSI landscape, we surveyed expert stakeholder views on ELSI challenges and solutions associated with pMRI research.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 4","pages":"786-804"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Socioeconomic Factors in Brain Research: Increasing Sample Representativeness with Portable MRI. 脑研究中的社会经济因素：便携式MRI增加样本代表性。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2025-01-31 DOI: 10.1017/jme.2024.168
Martha J Farah
{"title":"Socioeconomic Factors in Brain Research: Increasing Sample Representativeness with Portable MRI.","authors":"Martha J Farah","doi":"10.1017/jme.2024.168","DOIUrl":"10.1017/jme.2024.168","url":null,"abstract":"<p><p>People of low socioeconomic status (SES) are often underrepresented in biomedical research. The importance of demographically diverse research samples is widely recognized, especially given socioeconomic disparities in health, but have been challenging to achieve. One barrier to research participation by low SES individuals is their distance from research centers and the difficulty of traveling. This article examines the promise of portable magnetic resonance imaging (pMRI) for enrolling participants of diverse SES in structural neuroimaging studies, and anticipates some of the challenges, practical and ethical, that may arise in the course of such research.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 4","pages":"824-829"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Challenges for the Pro-Life Movement in a Post-Roe Era - ERRATUM. 后罗伊时代支持生命运动面临的挑战 - ERRATUM.
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2024-02-26 DOI: 10.1017/jme.2024.32
Cathleen Kaveny
{"title":"Challenges for the Pro-Life Movement in a Post-<i>Roe</i> Era - ERRATUM.","authors":"Cathleen Kaveny","doi":"10.1017/jme.2024.32","DOIUrl":"10.1017/jme.2024.32","url":null,"abstract":"","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"207"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139974257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
INTRODUCTION: Medical-Legal Partnerships: Equity, Evolution, and Evaluation - CORRIGENDUM. 简介：医学与法律的伙伴关系：公平、演变和评估》 - CORRIGENDUM.
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2024-04-16 DOI: 10.1017/jme.2024.50
Katherine L Kraschel, James Bhandary-Alexander, Yael Z Cannon, Vicki W Girard, Abbe R Gluck, Jennifer L Huer, Medha D Makhlouf
{"title":"INTRODUCTION: Medical-Legal Partnerships: Equity, Evolution, and Evaluation - CORRIGENDUM.","authors":"Katherine L Kraschel, James Bhandary-Alexander, Yael Z Cannon, Vicki W Girard, Abbe R Gluck, Jennifer L Huer, Medha D Makhlouf","doi":"10.1017/jme.2024.50","DOIUrl":"10.1017/jme.2024.50","url":null,"abstract":"","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"208"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140871031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
"A Most Equitable Drug": How the Clinical Studies of Convalescent Plasma as a Treatment for SARS-CoV-2 Might Usefully Inform Post-Pandemic Public Sector Approaches to Drug Development. "最公平的药物"：将康复血浆作为治疗 SARS-CoV-2 的临床研究如何为大流行后公共部门的药物开发方法提供有用信息。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2024-05-31 DOI: 10.1017/jme.2024.51
Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway
{"title":"\"A Most Equitable Drug\": How the Clinical Studies of Convalescent Plasma as a Treatment for SARS-CoV-2 Might Usefully Inform Post-Pandemic Public Sector Approaches to Drug Development.","authors":"Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway","doi":"10.1017/jme.2024.51","DOIUrl":"10.1017/jme.2024.51","url":null,"abstract":"<p><p>Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 1","pages":"80-97"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141181256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategy, Morality, Courage: Bioethics and Health Law after Dobbs. 战略、道德、勇气：多布斯之后的生命伦理学和卫生法》。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2024-01-01 Epub Date: 2024-10-22 DOI: 10.1017/jme.2024.104
Nancy M P King, Christine Nero Coughlin, Beverly J Levine
{"title":"Strategy, Morality, Courage: Bioethics and Health Law after <i>Dobbs</i>.","authors":"Nancy M P King, Christine Nero Coughlin, Beverly J Levine","doi":"10.1017/jme.2024.104","DOIUrl":"10.1017/jme.2024.104","url":null,"abstract":"<p><p>Our paper examines what is required to protect and promote effective public discussion and policy development in the current climate of divisive disagreement about many public policy questions. We use abortion as a case example precisely because it is morally fraught. We first consider the changes made by <i>Dobbs</i>, as well as those which led up to the <i>Dobbs</i> decision, accompany it, and follow from it.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"52 2","pages":"290-308"},"PeriodicalIF":1.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142479453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","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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