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

{"title":"Evaluating the Impact of Patient Recruitment and Retention Practices","authors":"Mary Jo Lamberti, A. Mathias, J. Myles, D. Howe, K. Getz","doi":"10.1177/0092861512453040","DOIUrl":"https://doi.org/10.1177/0092861512453040","url":null,"abstract":"The objectives of this study were to benchmark patient recruitment and retention practices across recently completed global clinical trials from a working group of biopharmaceutical companies. The data collection focused on recruitment and retention tactics used by companies as well as detailed information about the size and scope of the global trials conducted. In-depth organizational information regarding patient recruitment and retention structure and functions was collected. Despite numerous tactics available, participating companies indicated using a small number of patient recruitment and retention tactics. In addition, companies reported that 32% of studies did not implement any tactics. Traditional tactics were most widely used, including physician referrals (16%), newspaper advertisements (16%), and radio advertisements (13%). The relationship between use of recruitment tactics and enrollment data was explored and a positive association was found between use of nontraditional recruitment tactics and enrollment rates.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"139 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115894012","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":"An Exploratory Evaluation Framework for e-Clinical Data Management Performance","authors":"Hyunju Lee, Sangwon Lee","doi":"10.1177/0092861512452119","DOIUrl":"https://doi.org/10.1177/0092861512452119","url":null,"abstract":"Electronic data management is becoming important to reduce the overall cost and run-time of clinical trials with enhanced data quality. It is also imperative to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop an exploratory performance evaluation framework for e-clinical data management. This study performs a Delphi survey for 3 iterative rounds to develop an exploratory framework based on key informants’ knowledge. Four key metrics in the areas of infrastructure, intellectual preparation, study implementation, and study completion covering major aspects of clinical trial processes are proposed. Performance measures evaluate the extent of regulation compliance, data quality, cost, and efficiency of the electronic data management process. They also provide measurement indicators for each evaluation item. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management—clinical site, monitoring, and data coordinating center. From this initial attempt to evaluate the extent of electronic data management in clinical trials by a Delphi survey, further empirical studies are planned and recommended.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"85 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122035899","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":"Indicator-Based Assessment on Antimalarial Drug Availability and Utilization Among Selected Public Health Facilities in Southwest Ethiopia","authors":"A. Tessema, A. Ayane, N. Wabe","doi":"10.1177/0092861512452122","DOIUrl":"https://doi.org/10.1177/0092861512452122","url":null,"abstract":"Malaria is one of the most important causes of morbidity and mortality in tropical and subtropical countries. The availability, appropriate management, and rational use of medicines are critical to the successful implementation of the malaria control programs. The aim was to assess the availability, use, and utilization of medicines used for preventing and treating malaria in public health facilities in Jimma zone in Southwest Ethiopia. An indicator-based descriptive cross-sectional study was conducted from March 25 to April 30, 2011 at selected public health facilities, providing antimalaria drugs to treat and prevent malaria in Jimma zone. Three data collection techniques were used: document reviews, structured interviews, and physical inventory checks using the World Health Organization Checklist. All data collected were then analyzed using the Statistical Package for the Social Sciences (SPSS), version 16.0 software. On average, 88% of the core medicines monitored was available in the public health facilities and 90% of the medicines prescribed by the prescriber were dispensed to the patients. On average, stock out period was 38%. The highest and lowest prescribed antimalaria drugs observed are Artemether/lumefantrine 120 mg/20 mg tablet and chloroquine syrup, which were 45% and 5.5%, respectively. The adherence to Standard Treatment Guidelines of Ethiopia (STG) was 85%. There was poor inventory control system and long stock out period, and the majority of prescribers are adhering to national STGs. Implementing good inventory control system, training on drug supply management, and continuous supervision of the public health facilities by zonal health bureau is recommended.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"88 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123399734","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":"Associate Editor’s Commentary: The Tao of Biosimilars","authors":"Peter J. Pitts","doi":"10.1177/0092861512444779","DOIUrl":"https://doi.org/10.1177/0092861512444779","url":null,"abstract":"The age of the blockbuster is over. Cost concerns are more challenging than ever, and we are struggling to understand what ‘‘personalized medicine’’ really means. We are now in the era of post-patent medicine where advances in manufacturing and molecular diagnostics are as important as new molecular entities, and safety is as important (and as improvable) as efficacy. The era of post-patent medicine is also the epoch of biosimilars. A question of interest is whether biosimilars can really be as important an element of change as many believe. Will they be a game changer, and will all the changes that they bring positively affect the advancement of the public health? Many fear the expectations that biosimilars will radically reduce costs are overstated. Others fear that safety concerns are being understated and that the risks to innovation are real. Let us address each of these concerns in order. First, consider safety. It’s always important to begin a discussion of biosimilars and safety by reminding ourselves that there is no such thing as a generic biologic. ‘‘Big’’ molecules are more than just a larger version of ‘‘small’’ ones. Biologics are created from living organisms and are not as simple to replicate as traditional drugs like aspirin and antihistamines. Biosimilar safety means something different than generic drug safety. (See Table 1 for a list of terminology.) To establish that two protein products are similar and substitutable, the sponsor of a follow-on product would need to demonstrate through de novo clinical trials that repeated switches from the follow-on product to the referenced product (and vice versa) have no negative effect on the safety and/or efficacy of the products as a result of immunogenicity. In the case of biosimilars, the most important issues facing global drug regulators are the scientific and technical factors related to a determination of biosimilarity or interchangeability. For many follow-on protein products—and in particular, the larger proteins—there is a significant potential for repeated switches between products to have a negative impact on patient safety and clinical effectiveness. Therefore, the ability to make determinations of substitutability for biosimilars may be limited. This uncomplicated and indisputable fact is, alarmingly, rarely discussed by health care systems that see biosimilars exclusively as a cost-savings mechanism. But the blinders of cost containment must never be permitted to obscure the twin therapeutic pillars of safety and efficacy. Next, consider cost. Another crucial difference between biosimilars and small molecule generics is that they are difficult and expensive to get approved, are complicated and challenging to manufacture, and have a short shelf life. The result is that the price differential between innovator biologics and biosimilars will be far narrower than between branded small molecules and their generic counterparts. Another impediment to radical price declines is th","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134538548","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":"Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US Investigational New Drug Application","authors":"J. Mitchel, Judith M. Schloss Markowitz, H. Yin, D. Gittleman, T. Cho, Y. J. Kim, Joonhyuk Choi, M. Efros, K. Weingard, V. Tantsyura, D. Carrara","doi":"10.1177/0092861512449530","DOIUrl":"https://doi.org/10.1177/0092861512449530","url":null,"abstract":"In order to assess the impact of direct data entry (DDE) on the clinical trial process, a single-site, phase 2 clinical trial, under a US investigational new drug application (IND), was performed where the clinical site entered each subject’s data into an electronic data capture (EDC) system at the time of the office visit and the clinical research team implemented a risk-based monitoring (RBM) plan. For DDE, the trial used EDC for data collection and the electronic clinical trial record (eCTR) as the subject’s electronic source (eSource) record. A clinical data monitoring plan (CDMoP) defined the scope of source document verification, the frequency and scope of online data review, and the criteria for when to perform onsite monitoring. As a result of this novel approach to clinical research operations, (1) there were no protocol violations as screening errors were picked up prior to treatment; (2) because there were minimal transcription errors from paper source records to the EDC system, there was a major reduction in onsite monitoring compared to comparable studies that use paper source records; (3) EDC edit checks were able to be modified early in the course of the clinical trial; (4) compliance issues were identified in real time and corrected; (5) there was rapid transparency and detection of safety issues; and (6) the clinical site indicated that there were major cost savings overall and estimated that just in terms of data entry, it was able to save 70 hours of labor by not using paper as the original source records. It is postulated that once the pharmaceutical industry adopts DDE and RBM, there will be major increases in productivity for sponsors, clinical sites, and CROs, as well as reduced time to database lock and the statistical analyses. In addition to the productivity increases, these processes and tools will improve data integrity and quality and potentially reduce overall monitoring resources and efforts by an estimated 50% to 60%.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130626895","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":"Editor’s Commentary: Celebrating the Journal’s New Name— Therapeutic Innovation & Regulatory Science\u0000","authors":"J. R. Turner","doi":"10.1177/0092861512442115","DOIUrl":"https://doi.org/10.1177/0092861512442115","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"130 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116583967","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 Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions","authors":"P. Desai, C. D. Anderson, W. Sietsema","doi":"10.1177/0092861512446807","DOIUrl":"https://doi.org/10.1177/0092861512446807","url":null,"abstract":"With increasing globalization of clinical trials, there is a growing concern regarding the quality of data generated from clinical studies conducted in some of the emerging regions. This concern has not been comprehensively addressed thus far because there is limited public access to restricted databases. In this study, we utilized data from 26 large phase II/III trials conducted in multiple regions of the globe by members of the Association of Clinical Research Organization and compared query rates, one of the few measurable parameters of quality of clinical trials data, between different global regions. A query is generated when a discrepancy is noted between protocol or source data and the case report forms (CRFs). A resolution of such an inconsistency is necessitated, which may result in a database change. The studies included in our analyses were conducted at 4721 global sites enrolling 63,871 participants. Overall, the data set included 1.39 million queries, 7.5 million CRF pages, and 95 million data parameters. The number of queries for various regions was added for each trial and normalized to the number of CRF pages or to the number of CRF data parameters. The calculated mean query rates and database change rates were compared using parametric and nonparametric statistical approaches. None of these approaches revealed statistically significant differences in the query rates or the rate of database change when each region was compared to North America or Western Europe. Thus, a comparative assessment of query rates suggests that the quality of clinical trials conducted in emerging countries is consistent with those conducted in developed regions. Despite several limitations of our analyses and the multifaceted complexities of global clinical trials, our findings should alleviate some concerns regarding clinical studies conducted in emerging nations.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122361890","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":"DIA 2012 48th Annual Meeting Student Poster Abstracts","authors":"","doi":"10.1177/0092861512449813","DOIUrl":"https://doi.org/10.1177/0092861512449813","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116855084","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 Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries\u0000","authors":"E. Tabor","doi":"10.1177/0092861512450569","DOIUrl":"https://doi.org/10.1177/0092861512450569","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128283302","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":"Regulation of Herbal Dietary Supplements: Is There a Better Way?","authors":"A. Zakaryan, Irwin G. Martin","doi":"10.1177/0092861512452121","DOIUrl":"https://doi.org/10.1177/0092861512452121","url":null,"abstract":"This article outlines the importance of herbal dietary supplements regulation by providing a brief overview of history of supplement regulation in the US with emphasis placed on passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and post-DSHEA enforcement actions. This review also addresses international aspects of dietary supplement regulatory processes. The controversy surrounding the separation of structure/function claims from health claims is examined. Safety issues are summarized and the following proposals are offered to improve the herbal dietary supplements regulatory system. First, herbal dietary supplements should be subject to more strict regulation by the FDA, which means treating them more like pharmaceuticals and not like food. Only pre-market approval can guarantee consumer access to safe and effective product. Second, a suggested simplified procedure allows the registration of a traditional herbal dietary supplement. Third, due to the compositional diversity and complexity of botanical substances, every new submission of nontraditional herbal supplement must be processed on a case-by-case basis. Fourth, a mandatory post-marketing reporting system of all adverse events should be established rather than the current serious adverse event reporting scheme. And finally, legislative reform is needed to change the regulatory system of dietary supplements.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121268386","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}