Drug information journal : DIJ / Drug Information Association最新文献_第9页

Practical Considerations and Strategies for Executing Adaptive Clinical Trials 实施适应性临床试验的实际考虑和策略

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-03-01 DOI: 10.1177/0092861512436580

Weili He, O. Kuznetsova, M. Harmer, C. Leahy, K. Anderson, Nicole Dossin, Lina Li, J. Bolognese, Y. Tymofyeyev, Jerald S. Schindler

{"title":"Practical Considerations and Strategies for Executing Adaptive Clinical Trials","authors":"Weili He, O. Kuznetsova, M. Harmer, C. Leahy, K. Anderson, Nicole Dossin, Lina Li, J. Bolognese, Y. Tymofyeyev, Jerald S. Schindler","doi":"10.1177/0092861512436580","DOIUrl":"https://doi.org/10.1177/0092861512436580","url":null,"abstract":"There is great potential for clinical trials designed with adaptive features to result in more efficient decision making within a drug development program. However, clinical trials with adaptive features are more complex to implement than traditional designs such as fixed-sample or group sequential. Workarounds and/or inefficiencies in adaptive design (AD) trial execution may result in human and material wastes. Further, they may result in the introduction of operational biases that may potentially negate any gains in designing an AD trial and may even render trial results not interpretable. In this article, we present and share our experience and best practices in AD trial implementation in the areas of resource planning, randomization considerations including the importance of randomization schemes on clinical supply, Interactive Voice Randomization System vendor capability assessment and quality control, clinical supply strategy considerations, enrollment management and patient enrollment modeling and simulation, data quality and interim analysis planning, managing blinding and unblinding, and the use of a data monitoring committee.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126982997","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: 16

Industry Support of Key Opinion Leaders 关键意见领袖的行业支持

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-03-01 DOI: 10.1177/0092861511435908

Elizabeth Neglia, N. Singh-Radcliff, B. Minzter, W. Kofke

引用次数: 0

Providing Medical Information for Orphan Drugs 为孤儿药提供医疗信息

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427696

S. Turbeville, D. A. Wells, C. Hornfeldt

引用次数: 0

Text Analytics for Surveillance (TAS): An Interactive Environment for Safety Literature Review 文本分析监测(TAS):安全的互动环境文献综述

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511428890

Camilla Christensson, Geoffrey Gipson, Tracey Thomas, J. Weatherall

{"title":"Text Analytics for Surveillance (TAS): An Interactive Environment for Safety Literature Review","authors":"Camilla Christensson, Geoffrey Gipson, Tracey Thomas, J. Weatherall","doi":"10.1177/0092861511428890","DOIUrl":"https://doi.org/10.1177/0092861511428890","url":null,"abstract":"Pharmacovigilance regulations and guidelines state that literature databases should be searched at least monthly to detect safety signals from the published literature. In addition, periodic safety update reports (PSURs) should contain a summary and references from reports in the literature containing important safety findings. The volume of literature that needs to be reviewed is high, making manual review of the abstracts a resource-intensive process. Text Analytics for Surveillance (TAS) was developed as a software tool to improve the efficiency and consistency of the routine literature evaluation, tracking, and documentation process within a regulated pharmaceutical environment. Text Analytics for Surveillance uses natural language processing and includes a novel application of text analytics to assist with identifying the most relevant articles in the process of scheduled surveillance of published literature by enhancing categorized review, introducing consistency of approach, ensuring rigorous recording of activities, and aiding profile analysis. There are clear opportunities to reuse the TAS approach within other scientific and business areas where regular literature evaluation is important.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"35 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125378956","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: 1

Flexible Phase I Study Designs: Expediting Early Clinical Drug Development 灵活的I期研究设计:加快早期临床药物开发

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427865

D. Underwood

引用次数: 0

The Role of Pharmaceutical Medical Information in Promotional Review: Three Benchmarking Surveys 医药信息在促销审查中的作用:三个基准调查

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427873

Lisa M. Bonk, M. Kothari, Alyson Sous Andrikanich, Ellen Yang

{"title":"The Role of Pharmaceutical Medical Information in Promotional Review: Three Benchmarking Surveys","authors":"Lisa M. Bonk, M. Kothari, Alyson Sous Andrikanich, Ellen Yang","doi":"10.1177/0092861511427873","DOIUrl":"https://doi.org/10.1177/0092861511427873","url":null,"abstract":"Pharmaceutical Medical Information (MI) departments have many different responsibilities within the organization. In addition to the traditional roles of Medical Information professionals, promotional review is a growing responsibility. Three benchmarking surveys explored the role and involvement of the Medical Information department in promotional review and were conducted within a similar timeframe (2009). The surveys were designed to provide insights into current practices within the pharmaceutical industry and to characterize the function and contribution of Medical Information departments in the promotional review process. The surveys focused on promotional review in terms of types of materials reviewed, procedures, and time commitment. Most pharmaceutical Medical Information professionals surveyed reported that they participated in the promotional review process. They have a number of responsibilities as part of the promotional review process that may include reviewing promotional materials, attending formal review meetings, and serving as final medical sign-off. It was reported that the time Medical Information professionals spent on promotional review made up a substantial portion of their workload. These findings provide insights into the similarities and differences in Medical Information departments’ role in promotional review across the pharmaceutical industry. Medical Information representatives and supervisors may use these results to benchmark their involvement in promotion review, consider new practices, or address challenges within their own departments.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126787652","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: 5

Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research 生物医学研究知情同意书中技术术语的接触和理解

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427878

I. Jeong, Dong-Hee Kim, Myung-Hee Kim, So Hee Kim, Dong-Wook Jeong, J. Shon

{"title":"Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research","authors":"I. Jeong, Dong-Hee Kim, Myung-Hee Kim, So Hee Kim, Dong-Wook Jeong, J. Shon","doi":"10.1177/0092861511427878","DOIUrl":"https://doi.org/10.1177/0092861511427878","url":null,"abstract":"This cross-sectional survey with 432 patients and 158 nurses investigated the exposure to and understanding of technical terms used in informed consent forms (ICFs) for biomedical research in the Republic of Korea. The percentage of positive responses, when asked if ever exposed to the study-related terms, ranged from 4.9% to 80.8% for patients and 22.8% to 99.4% for nurses. The term phase III was least recognized by both patients and nurses. The percentage of positive responses to “understanding the study-related terms well” ranged from 0.9% to 56.2% for patients and 5.1% to 70.9% for nurses. The average number of positive respondents, when asked if they understood each term well, statistically differed by age group, education, and exposure to clinical research for patients and by education and exposure to biomedical research for nurses. The low level of understanding of technical terms in ICFs should be improved by ensuring that sufficient explanations are provided to patients while obtaining informed consent and by replacing terms with more common and easily understandable words.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124748736","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: 2

Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review 开发和应用记分卡来评估监管提交及其审查的质量

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427694

S. Salek, A. Mallia-Milanes, N. McAuslane, S. Walker

{"title":"Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review","authors":"S. Salek, A. Mallia-Milanes, N. McAuslane, S. Walker","doi":"10.1177/0092861511427694","DOIUrl":"https://doi.org/10.1177/0092861511427694","url":null,"abstract":"An efficient review depends not only on timely approval but also on ensuring the qualityof the processfrom construction of the dossier to the ultimate regulatory decision. Two scorecards were developed through a process of conceptualization, item generation, and reduction, as well as psychometric testing, for regulatory authorities to provide feedback to companies on the quality of their submissions while companies report to authorities on the quality of their review. The scorecards included more than 50 items grouped into 7 domains, including application format, content of the dossier, labeling, scientific advice, conduct of the review, communication, and overall assessment. The scorecards were then tested by 3 major regulatory authorities (Health Canada, Swissmedic, and Therapeutic Goods Administration, Australia) and 4 international pharmaceutical companies (AstraZeneca, GlaxoSmithKline, Novo Nordisk, andPfizer). The study participants responded openly to requests for ratings on the quality of performance bythe other parties based on retrospective reviews. The data gave insights into different perceptions of quality in relation to submitted data and their respective review procedures. The findings showed the value and applicability of the proposed scorecards.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122157275","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: 8

The Association Between Leukotriene-Modifying Agents and Spontaneously Reported Suicide 白三烯修饰剂与自述自杀之间的关系

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427856

G. Schumock, R. Gibbons, Todd A. Lee, M. Joo, L. Stayner, R. Valuck

{"title":"The Association Between Leukotriene-Modifying Agents and Spontaneously Reported Suicide","authors":"G. Schumock, R. Gibbons, Todd A. Lee, M. Joo, L. Stayner, R. Valuck","doi":"10.1177/0092861511427856","DOIUrl":"https://doi.org/10.1177/0092861511427856","url":null,"abstract":"The purpose of this study was to examine the association between leukotriene-modifying agents (LTMAs) and completed suicide. Data from the Food and Drug Administration (FDA) Adverse Event Reporting System from 1999 to 2009 were used to identify the number of completed suicides for each LTMA. Data from IMS Health were used to determine the number of prescriptions dispensed by drug in the same time period. The authors calculated the rate of completed suicides per million prescriptions and, using a mixed-effects Poisson regression analysis, determined the empirical Bayes (EB) rate multipliers and 95% confidence intervals for each drug. Selective serotonin-reuptake inhibitors (SSRIs) and short-acting beta-agonist (SABAs) were analyzed for comparison purposes. There were 105 completed suicides reported where a LTMA was implicated. Most (n ¼ 101) involved montelukast, and all but 9 occurred in 2008 to 2009, following an FDA warning. Aggregated suicide rates over the 1999-2009 period were 0.51, 0.24, and 4.09 per million prescriptions for montelukast, zafirlukast, and zileuton. The suicide rate as a class was 0.06 per million prescriptions in the prewarning period and 1.82 per million prescriptions in the postwarning period. Montelukast was associated with a significantly lower rate of suicide when compared to SSRIs and a significantly higher rate when compared to SABAs.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127506290","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: 7

An In-Process Scaling Model: A Potential Framework for Data Monitoring Committees and Clinical Trial Quality Improvement 过程中缩放模型:数据监测委员会和临床试验质量改进的潜在框架

Drug information journal : DIJ / Drug Information Association Pub Date : 2012-01-01 DOI: 10.1177/0092861511427864

Alan F. Smith, Jonathan H Seltzer

引用次数: 1