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Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation 寻找影响临床试验中止的可预测的受试者特征
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-05-01 DOI: 10.1177/0092861512440850
J. Yadlapalli, Irwin G. Martin
{"title":"Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation","authors":"J. Yadlapalli, Irwin G. Martin","doi":"10.1177/0092861512440850","DOIUrl":"https://doi.org/10.1177/0092861512440850","url":null,"abstract":"Subject retention is one of the key factors that determine success of a clinical trial. Many researchers have focused on the issue of recruitment, and few have focused on retention. Subjects discontinue from clinical trials for variety of reasons. Sociodemographic characteristics such as age, gender, race, employment, and level of education have been implicated as the most common influencers for participation in clinical trials. This study evaluated the influence of these sociodemographic characteristics on the risk of subject discontinuation. There was little apparent difference in the sociodemographic characteristics among completers and discontinued subjects. Importantly, it was noticed that there is no common format for reporting clinical trial sociodemographic characteristics, thus leading to difficulties in the interpretation of the influence of such factors on subject retention. Suggestions are provided for future researchers that would greatly enhance the prediction of sociodemographic influences on subject discontinuation. Strategies to overcome such influences may be required.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"2 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121016106","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
Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program 肿瘤临床发展项目中伴随诊断的决策制定
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-05-01 DOI: 10.1177/0092861512438748
L. Kaiser, Claus Becker, S. Kukreti, B. Fine
{"title":"Decision Making for a Companion Diagnostic in an Oncology Clinical Development Program","authors":"L. Kaiser, Claus Becker, S. Kukreti, B. Fine","doi":"10.1177/0092861512438748","DOIUrl":"https://doi.org/10.1177/0092861512438748","url":null,"abstract":"The decision to incorporate the specific evaluation of a candidate companion diagnostic (CDx) in a clinical development plan (CDP) is often difficult and is exacerbated by the lack of relevant decision tools. In this article, we discuss a novel method to assess the probability of technical success (PTS) of a CDP that adequately evaluates a CDx compared with a CDP that doesn’t. We propose splitting the PTS into subjective (biological uncertainty) and quantitative (clinical uncertainty) components, assessing each separately, and then combining them in a decision theoretical manner to obtain an overall success probability of a CDP with and without a CDx.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131240081","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
Editor’s Commentary: Assessing Worst-Case Scenarios in Regulatory Science 编者评论:评估监管科学中的最坏情况
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-27 DOI: 10.1177/0092861512445792
J. R. Turner
{"title":"Editor’s Commentary: Assessing Worst-Case Scenarios in Regulatory Science","authors":"J. R. Turner","doi":"10.1177/0092861512445792","DOIUrl":"https://doi.org/10.1177/0092861512445792","url":null,"abstract":"Last year we introduced several new categories of submissions, including Letters to the Editor. The first two letters were published in the September 2011 issue of the Journal, one from Dr Norman Stockbridge (FDA) and the other from Dr Larry Satin (Cardiocore). Both letters addressed an Expert Commentary on ambulatory blood pressure measurement (ABPM) by Professor Eoin O’Brien entitled ‘‘Why ABPM Should Be Mandatory in All Trials of Blood Pressure–Lowering Drugs.’’ Of note is that one comment contained in Dr Stockbridge’s letter has already been highlighted by speakers at several international conferences, and has therefore generated ongoing discussion. This issue of the Journal contains two Commentary pieces, one from Associate Editor Peter Pitts (president, Center for Medicine in the Public Interest, New York) and the other from Dr Michael Weber (professor of medicine at SUNY Downstate College of Medicine and chairman of the Center for Medicine in the Public Interest). They discuss issues of central importance to the practice of medicine in the United States, and Letters to the Editor from readers in response to these issues are encouraged.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129893421","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
Associate Editor’s Commentary: Government Detailing 副编辑评论:政府细节
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-27 DOI: 10.1177/0092861512443437
Peter J. Pitts
{"title":"Associate Editor’s Commentary: Government Detailing","authors":"Peter J. Pitts","doi":"10.1177/0092861512443437","DOIUrl":"https://doi.org/10.1177/0092861512443437","url":null,"abstract":"“Newspeak,” as Orwellian cognoscenti know, is the official language of Oceania—the land ruled by Big Brother. Newspeak was designed “not to extend but to diminish the range of thought.” Its goal was to “make all other modes of thought impossible.” All of which brings us from the nightmare fantasy of 1984 Newspeak to the health care debate of 2012, the concept of “academic detailing,” and a new term we must all become familiar with— cost-think (which defines everything that reduces short-term costs as a benefit to the patient).","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"93 7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126048396","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
Outcome Measures in Study Registries: The Need for a Consistent Approach 研究登记的结果测量:需要一致的方法
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-26 DOI: 10.1177/0092861512444030
H. Forst, R. Paarlberg
{"title":"Outcome Measures in Study Registries: The Need for a Consistent Approach","authors":"H. Forst, R. Paarlberg","doi":"10.1177/0092861512444030","DOIUrl":"https://doi.org/10.1177/0092861512444030","url":null,"abstract":"The definition of outcome measures is the core part of a clinical study protocol and is also key information when posting the protocol and results information from a study on registries like https://doi.org/ClinicalTrials.gov . Unfortunately, there are some differences in terminology and language used in study protocols and study registries. At first glance, these discrepancies might not appear to be that important, but they have the potential to introduce critical inconsistencies. In this article, we give an overview of definitions and issues in this area, report about the harmonization efforts under the Clinical Data Interchange Standards Consortium (CDISC) and Health Level Seven (HL7) initiatives, and provide a SMART principle to improve the definition for outcome measures. For clear communication and interpretation of the study information, we need a common language that harmonizes the terminology between the study protocol and the information posted on different study registries to avoid serious misunderstandings as well as wrong conclusions.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131833418","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
Potential Factors Influencing Regional Differences and Similarities in Multiregional Clinical Trials 影响多区域临床试验区域差异和相似性的潜在因素
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-20 DOI: 10.1177/0092861512443747
M. Ohishi
{"title":"Potential Factors Influencing Regional Differences and Similarities in Multiregional Clinical Trials","authors":"M. Ohishi","doi":"10.1177/0092861512443747","DOIUrl":"https://doi.org/10.1177/0092861512443747","url":null,"abstract":"In a multiregional clinical trial (MRCT), determining whether regional differences occur by chance or whether they are due to differences in pharmacokinetics, pharmacodynamics, or other prognostic factors is important to accurately evaluate the true efficacy of a drug in patients of each region. The general probability that regional results will differ from total results has been studied using statistical simulation. Consideration from the pharmacokinetic perspective is necessary as well to investigate the causes of regional differences. Patient characteristics may vary among regions, and differences in medical environment such as commonly used drugs and treatment guidelines can affect regional efficacy and safety results. Moreover, bias may be introduced in the data collected due to differences such as in diagnosis, assessment criteria, and reporting conditions. In this research, the factors and mechanism potentially influencing results by region in MRCT are examined, referring to the results of MRCTs already published.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134550870","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
Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs 欧盟的混合或混合上市许可申请:在已上市药物的新开发项目中不是一个微不足道的决定
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-19 DOI: 10.1177/0092861512443748
A. Vogel
{"title":"Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs","authors":"A. Vogel","doi":"10.1177/0092861512443748","DOIUrl":"https://doi.org/10.1177/0092861512443748","url":null,"abstract":"For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market exclusivity, and the pediatric requirements in a significant way. For new development projects for established active substances, including new strengths, dosage forms, routes of administration, and new indications, the correct choice of legal basis is critical. This article presents the dossier requirements, data protection, and market exclusivity as well as pediatric obligations for mixed MAAs using the Article 8(3) legal basis and so-called “hybrid” applications according to Article 10(3). These legal bases in the European Union are contrasted with applications according to section 505(b)(2) in the United States. A number of case studies are presented to illustrate which factors can determine the legal basis of an MAA.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130962733","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: 4
Testing Marginal Homogeneity in Matched-Pair Polytomous Data 匹配对多同构数据的边缘同质性检验
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-12 DOI: 10.1177/0092861512442021
Zhao Yang, Xuezheng Sun, J. Hardin
{"title":"Testing Marginal Homogeneity in Matched-Pair Polytomous Data","authors":"Zhao Yang, Xuezheng Sun, J. Hardin","doi":"10.1177/0092861512442021","DOIUrl":"https://doi.org/10.1177/0092861512442021","url":null,"abstract":"Statistical tests for assessing marginal homogeneity of matched-pair polytomous data can be classified as a score-type test or a Wald-type test; the Wald-type Bhapkar test is a more powerful alternative to the score-type Stuart–Maxwell test, and the Bhapkar test tends to be liberal. Extending the authors’ earlier work, an additional test of each classification is proposed for testing marginal homogeneity, and the relationships among the available test statistics are established. The results from some limited simulation study suggest that the new proposals are very competitive alternatives to the extant methods. These results are the basis of the authors’ recommendations to practitioners. Information from SAS procedure PROC CATMOD regarding Bhapkar’s test statistic and the relationship among the test statistics make their implementation and calculation convenient and accessible to interested researchers.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122509283","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: 3
Building Value Through Biomarkers: The “Smarter Development” Imperative 通过生物标记物创造价值:“更智能的发展”势在必行
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-12 DOI: 10.1177/0092861512441392
Brad Smith, M. Stocum, C. Verst, Oren Cohen
{"title":"Building Value Through Biomarkers: The “Smarter Development” Imperative","authors":"Brad Smith, M. Stocum, C. Verst, Oren Cohen","doi":"10.1177/0092861512441392","DOIUrl":"https://doi.org/10.1177/0092861512441392","url":null,"abstract":"An increased focus on biopharmaceutical product differentiation has altered the business environment, placing the industry under immense pressure to reengineer a flawed business model that relied principally on inefficient internal research and development (R&D) programs. Companies are working to deliver safer and more effective treatments for disease targets that are increasingly complex, all the while having to contend with the considerable challenges of declining R&D productivity, increasing development costs, diminishing returns on sales, and lower earnings. Regulatory and reimbursement demands present yet another challenge. According to an Outlook 2009 report on pharmaceutical and biopharmaceutical trends from the Tufts Center for the Study of Drug Development, it still takes, on average, 8 years to bring a new drug to market. The industry’s survival depends in large part on its ability to select compounds with a high probability of clinical success and develop them very efficiently. Regulatory authorization of a product is only the first hurdle for biopharmaceutical sponsors to clear. The second hurdle, which should be taken into consideration further upstream in clinical development programs, is the ability to substantiate the product’s value on launch and to optimize the reimbursement status with real-world research. Proof of a medicine’s safety and efficacy will also be demanded as never before in this new environment, with the performance of new products being assessed against alternative treatments and their market viability determined by multiple stakeholders able to evaluate those treatments in ways never before possible.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127026028","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
Improvement of the Drug Allergy Alert for Nonprescription NSAIDs 非处方非甾体抗炎药药物过敏预警的改进
Drug information journal : DIJ / Drug Information Association Pub Date : 2012-04-10 DOI: 10.1177/0092861512440951
R. Soller, C. Shaheen, J. Yen, J. Rose, J. Lightwood
{"title":"Improvement of the Drug Allergy Alert for Nonprescription NSAIDs","authors":"R. Soller, C. Shaheen, J. Yen, J. Rose, J. Lightwood","doi":"10.1177/0092861512440951","DOIUrl":"https://doi.org/10.1177/0092861512440951","url":null,"abstract":"Objective The purpose of the study was to compare revised and current ibuprofen over-the-counter (OTC) allergy alerts for usability, readability, and overall preferences in consumers naive to drug allergies and drug-induced allergy survivors. Methods Label comprehension studies in naive consumers and survivors used standard measures for usability, readability, and preferences to rate new versus current content and format regarding time of onset, onset after prior safe use, syndrome name, progressive nature, symptoms, and use of capital letters. Results The revised allergy alert was statistically superior to the current alert as reported by all participants for overall preference, most new key content elements, and usefulness for first-time users (for each, P <.001). Survivors agreed the new alert applied to their drug allergy experience ( P <.001). Conclusions There is a gap of key information in the current OTC ibuprofen allergy alerts, demonstrating the need for revision of the OTC Drug Facts label.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125500374","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: 4
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