Drug information journal : DIJ / Drug Information Association最新文献

{"title":"The Effect of Feedback With Photo-Novella Information Sheets on Subjects’ Understanding in Informed Consent for Research","authors":"I. Jeong, Jang Hee Hong, S. Jung, Juhee Cho, J. Jeong","doi":"10.1177/0092861512456837","DOIUrl":"https://doi.org/10.1177/0092861512456837","url":null,"abstract":"This study aimed to investigate the effect of combined interventions composed of both quiz/feedback and information sheet format change performed after the standard informed consent process on the understanding of clinical study participants. The participants were 117 healthy volunteers: group A (n = 50) receiving a standard information sheet, group B (n = 50) receiving the photo-novella, and the control group (n = 17). The subjective understanding level increased from 82.5 to 90.0 out of 100 points ( P < 0.001) and objective understanding level from 13.9 to 16.1 out of 20 points ( P < 0.001) for the choice type and 14.0 to 15.7 points out of 20 points ( P < 0.001) for the short-answer type after providing quiz/feedback with any type of information sheets. However, photo-novella information sheet did not increase understanding levels more than the standard one. In conclusion, quiz/feedback with any type of information sheet can enhance the understanding in the informed consent of research.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124333862","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":"Heat Map Displays for Data From Human Abuse Potential Crossover Studies","authors":"Ling Chen, Yang Wang","doi":"10.1177/0092861512452120","DOIUrl":"https://doi.org/10.1177/0092861512452120","url":null,"abstract":"The human abuse potential study is an important part of the assessment of abuse potential of drugs. This type of study has multiple treatments and multiple abuse potential measures. The study is crossover and often uses a Williams square design. Data are collected for treatments from each treatment sequence and during each treatment period at many time points. This article proposes the use of heat maps to display complicated data sets. This graphic method provides a visual tool for exploring data from individual subjects and overall pictures of subject responses in human abuse potential studies.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115089789","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":"The Future of Allergen-Specific Immunotherapy","authors":"M. Jutel, K. Solarewicz-Madejek, S. Smolinska","doi":"10.1177/0092861512456283","DOIUrl":"https://doi.org/10.1177/0092861512456283","url":null,"abstract":"Allergen-specific immunotherapy (SIT) is the only known causal treatment of allergic diseases. The safety and efficacy of SIT have been demonstrated in humans in many clinical trials, which showed the essential role of SIT in preventing new allergies and asthma. However, SIT is not effective in all allergic individuals and is not equally effective in the treatment of various hypersensitivities to different allergens. For this reason, there is a strong need for research in the field of new SIT modalities to increase its effectiveness and safety. They include recombinant allergens or hypoallergenic variants that show the ability to activate T lymphocytes but decrease IgE binding, diminishing the anaphylaxis risk of the treatment. Growing evidence on different T cell subset functions provides new concepts on the safer and more effective vaccination strategies.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125745498","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":"Review of From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories\u0000","authors":"E. Tabor","doi":"10.1177/0092861512456838","DOIUrl":"https://doi.org/10.1177/0092861512456838","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"210 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131420943","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":"Join FDA/PhUSE Working Groups to Help Harness the Power of Computational Science","authors":"L. Rosario, T. Kropp, Stephen E. Wilson, Charles K. Cooper","doi":"10.1177/0092861512456839","DOIUrl":"https://doi.org/10.1177/0092861512456839","url":null,"abstract":"Consumers are often pleased by the accuracy with which online shopping websites are able to recommend new products they may be interested in. For example, how did the favorite shopping website of your wine-enthusiast neighbor, who recently purchased a highly durable dog crate for her separation anxiety–stricken canine, know that she would also be interested in 2 items not typically bought together: a do-it-yourself wine cork bulletin board kit and canine calming herbal supplements? Amazon.com, Pandora Radio, and Netflix, to name a few, have developed innovative means to weed through and translate the heaps of data generated from a consumer’s search and ‘‘purchase’’ history into precise product recommendations. Advances in information technology that have been extremely successful for consumer information delivery have also provided effective solutions to data-heavy projects in translational science, genomics, and business analytics. These advances have engendered fields and businesses that regulatory stakeholders can leverage against the mountains of data that accompany each medical product application in order to speed review time, reduce and refine clinical trial requirements, pinpoint postmarket safety signals, and facilitate regulatory science efforts, to name a few potential benefits. Increasingly complex informatics and data challenges must first be addressed in order to harness the potential of medical product development data. Aggregation and curation of data collected from various sources, in various forms, are heavy tasks in existing scientific environments. Data standards and associated tools can make the job of transforming data into knowledge a fast, efficient, and highly repeatable process. The first step, increasing the accessibility of data with standards, is only an enabling step. The full benefit of standardized data can only be actualized when combined with systems, tools, and procedures that allow the user to easily find answers to the scientific and regulatory questions that they face. The FDA and Pharmaceutical Users Software Exchange (PhUSE) have teamed up to tackle these challenges using collaboration, crowd sourcing, and innovation, a strategy similar to one used in 2011 by scientists who were unable to solve the crystal structure of a key retroviral protein. These innovative scientists cast a wide net in order to reach a solution by challenging nonscientist gamers to model the protein’s structure using their intuition and a protein folding game. In 3 weeks, gamers were able to accomplish what biochemists had been unable to achieve for more than a decade and provided the field with new insights for the design of antiretroviral drugs. Similar examples are now becoming more prevalent as we try to harness technical and human resources to address complex scientific and health-related issues. Earlier this year, the FDA and PhUSE cast their own wide net to solve common informatics needs and challenges by calling on all interest","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"144 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132386067","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":"Interventions Assessment of Prescription Automatic Screening System in Chinese Hospitals: A Systematic Review","authors":"Chunyan Yang, Lianping Yang, Xiaoxi Xiang, Yuqing Tang, Hongtao Wang, N. Bobai, Xinping Zhang","doi":"10.1177/0092861512454417","DOIUrl":"https://doi.org/10.1177/0092861512454417","url":null,"abstract":"Objectives To systematically assess the outcomes and effectiveness of Prescription Automatic Screening System (PASS) on rational drug use in China. Methods All studies that evaluated the effects of PASS in Chinese hospitals were electronically searched. Meta-analysis was used to assess the outcomes of intervention effects. Results Twelve articles that appraised the interventions related to PASS were identified. All studies used before-after designs. Risk ratio was chosen as the effect size index. Heterogeneity was large (I^2 > 50%) in all main analyses. Effect sizes were pooled using random effects. Compared with the control group, the pooled effect sizes were 0.60 (95% CI, 0.52-0.70) for the outcome of the incident of inpatient irrational drug use (n = 5), 0.75 (95% CI, 0.59-0.96) for the outcome of the incident of outpatient patient irrational drug use (n = 2), and 0.29 (95% CI, 0.10-0.86) for the outcome of the incidence of black-light warning orders (n = 6). Conclusions Interventions related to PASS was associated with the reduction of irrational drug use and medication errors.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"77 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126236417","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":"Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices","authors":"M. Hartmann, F. Hartmann-Vareilles","doi":"10.1177/0092861512453574","DOIUrl":"https://doi.org/10.1177/0092861512453574","url":null,"abstract":"Since 2010, discussions about more risk-proportionate trial authorization and supervision procedures gain momentum in the European Union and the United States. This article provides an overview of the current situation and analyses existing proposals for the risk-based assessment and categorization of clinical research. Experiences gained so far with the risk-based categorization and classification of trials and products in the pharmaceuticals and medical devices sector are described: they indicate that strict trial categorization systems would add burden to the whole process and could deliver benefit only within a very flexible regulatory framework. In contrast, partial exemptions from regulatory requirements for well-defined types of trials may respond better to the current expectations of stakeholders. For Europe, such exemptions could be adopted in a custom-made manner with the objective of facilitating the conduct of large, simple, evidence-building clinical trials as well as of patient-focused trials in situations of recognized unmet medical need.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128232409","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":"A Statistical Framework for Decision Making in Confirmatory Multipopulation Tailoring Clinical Trials","authors":"B. Millen, A. Dmitrienko, S. Ruberg, Lei-Bin Shen","doi":"10.1177/0092861512454116","DOIUrl":"https://doi.org/10.1177/0092861512454116","url":null,"abstract":"This article focuses on statistical analysis of clinical trials pursuing tailored therapy objectives, wherein evaluation of treatment effect occurs in the overall population as well as in a predefined subpopulation(s). The design and analysis principles presented provide a framework for decision making based on these novel multipopulation tailoring trial designs, considering the particular case of confirmatory trials. These principles include traditional multiple testing considerations, as well as 2 new analysis principles.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128251842","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":"Developing Standardized Data: Connecting the Silos","authors":"Charles K. Cooper, S. Buckman‐Garner, MaryAnn Slack, J. A. Florian, S. McCune","doi":"10.1177/0092861512454117","DOIUrl":"https://doi.org/10.1177/0092861512454117","url":null,"abstract":"We live in an electronic age where information is captured every second, and we have all learned to accept standards as a regular part of our lives. For example, the letters that we send through the postal service would likely never reach their final destination without a standardized format for addresses. In addition, when fire engines come from other municipalities to put out a fire in our neighborhood, we aren’t concerned with whether or not their trucks will be able to hook up to the local fire hydrants, because all connections are standard. Contrast this with the Great Baltimore Fire of 1904 where thousands of fire fighters from the surrounding cities and states were unable to assist as the fire raged for 30 hours, simply because their fire hoses were not compatible with the Baltimore hydrant connections. At present, we are witnessing an ever-increasing and soon to be overwhelming stream of data in our regulatory review pathways from electronic health records and clinical trials. Regulatory stakeholders, much like the fire fighters from 1904, need to develop those standard connections that will allow us to capture and fully utilize the wealth of available data in order to assist in addressing our most challenging health problems. While information capture typically calls to mind consumertargeted data collection, the medical and regulatory review settings also acquire massive amounts of data. Patients may be continuously monitored, and those data may be collected, stored, and used immediately for clinical decision making or used later for analysis of various metrics such as outcomes. Ideally, a patient’s medical information could be easily and automatically available to health care providers, regardless of the point of care; however, data from electronic health records captured in one medical facility are often not easily transferred to another. This clearly presents a hurdle in leveraging all available patient data in the health care setting. A similar hurdle exists for the data gathered from clinical trials where much of the data exist in ‘‘silos’’ because they are not collected consistently and may need to be converted from one form to another before submission to the regulatory agencies. Even essential data variables may be formatted differently between trials for a single product, across drug trials within a class, and for trials across drug classes. If these ‘‘silos’’ were connected, regulatory stakeholders would be empowered to more efficiently review data and ask more probing questions. One of the simplest examples of data standards challenges that regulatory agencies encounter is the representation of males versus females in clinical trials. The data may be presented in various ways such as ‘‘male and female,’’ ‘‘M and F,’’ ‘‘1 and 2,’’ or ‘‘0 and 1.’’ As one can imagine, inconsistencies of this sort can cause a host of problems when trying to group data from multiple clinical studies together and make assessments within and across t","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117145484","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":"Adverse Reaction Signaling and Disproportionality Analysis: An Update","authors":"G. Faich, Jonathan Morris","doi":"10.1177/0092861512453041","DOIUrl":"https://doi.org/10.1177/0092861512453041","url":null,"abstract":"There is an increased focus on signal detection, signal management, and the use of use of large collections of adverse event databases to meet the evolving regulatory mandates. The basic elements of signaling require an understanding of the different signaling methods, data mining approaches, and the strengths and limitations of disproportionality analysis. The application of signaling thresholds and the resulting statistical interpretation require an understanding of the methods themselves, as well as the strengths, limitations, and biases inherent in the adverse event data sources. This paper will highlight recent developments in these areas as well as provide cautions related to biases that affect reporting and analyses of adverse event databases.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121496895","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}