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

{"title":"Contraception Methods in Drug Labeling","authors":"Christianne O. Parotti, E. Ng, D. Wyszynski","doi":"10.1177/0092861512441099","DOIUrl":"https://doi.org/10.1177/0092861512441099","url":null,"abstract":"Background Recent studies have shown that approximately 1 in 6 women of reproductive age use potentially teratogenic medications. Since the pregnancy section in drug labeling is often inconsistent or incomplete, many pregnant women may inadvertently expose their fetus to potentially teratogenic drugs. Method We examined the pregnancy section in the labeling of 6 potentially teratogenic drugs: thalidomide, isotretinoin, leflunomide, warfarin sodium, alprazolam, and lisinopril. We also reviewed regulatory guidelines that address issues regarding contraception method use. Results The amount of information regarding contraception use in drug labeling varied. Occasionally, this information was not found altogether. Regulatory guidelines regarding contraception use, albeit useful, do not comprehensively cover all relevant areas. Conclusion There is a need for an internationally harmonized regulatory guideline that clearly defines when, how, and what type of contraception methods should be used, as well as what type of contraception information should be included in the labeling.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"17 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":"126224811","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":"Emerging Trends in US Oncological Approvals: A 13-Year Review (1999–2011)","authors":"Jing Huang, Wenze Zhang, D. Bowen, J. Tam, Hsiao-hui Wu, M. Fung","doi":"10.1177/0092861512441391","DOIUrl":"https://doi.org/10.1177/0092861512441391","url":null,"abstract":"Background Advances in medicine, clinical trial design, and statistical methods affect product approvals. Over the last decade, there were many breakthroughs in the development of novel cancer therapies, including the wide application of biomarkers in drug development. Understanding trends and patterns of trial design and data submissions that lead to the approval of these novel agents assists oncologists, investigators, and regulatory personnel. Methods All new molecular entity (NME) therapeutic oncological agents approved for the first time within the past 13 years (January 1, 1999 to December 31, 2011) were analyzed for product features, approved indications, regulatory metrics, and clinical trial design. Patterns and trends were reviewed. July 2005 marked the midpoint of this review, concurrent with the FDA establishing the Office of Oncology Drug Products (OODP). Regulatory metrics before and after the establishment of the OODP were compared and analyzed. The Fisher exact test was applied for statistical analyses. Results A total of 47 new oncological approvals were identified, 2 to 7 approvals per year (median, 3.0), with 6.0-month median reviews. Comparing the pre- and post-OODP period, there was trending towards more approvals (4.3/year vs 2.9/year) along with more targeted agent approvals (50% vs 21%) in the post-OODP period, although these metrics did not reach statistical significance due to relatively small numbers and large variances. There were also numerically fewer orphan designations (36% vs 53%) and accelerated approvals (32% vs 37%) in the post-OODP period. Approvals were for small molecule targeted agents, 38% (frequently kinase inhibitors); monoclonal antibodies, 17%; conventional cytotoxics, 28%; hormonal agents, 13%; and miscellaneous agents, 4%. Two 2011 approvals were associated with companion diagnostics. First-line indications accounted for only 36%; 62% were parenterally administered. Multinational, multicenter, randomized phase II or III trials utilizing overall survival or progression-free survival endpoints were common pivotal trial features in solid tumors. Hematological malignancy trials involved multiple small, single-arm phase II studies measuring mainly response rate, commonly resulting in accelerated approval. Placebo controls (19%) and blinding (24%) were both seldom employed. Conclusions Over the last 13 years, 55% of NME approvals were targeted agents or monoclonal antibodies, most not for first-line use. Most applications relied upon a single pivotal study for approval. Randomized trials supported most solid tumor approvals, whereas single-arm phase II studies supported (mostly accelerated) approvals in hematological malignancies. After establishment of the OODP, there were trends towards more approvals and less orphan designations.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125783976","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":"Working Conditions, Job Perceptions, Job Satisfaction, and Intentions to Stay at the Job for Clinical Research Coordinators in the Republic of Korea","authors":"I. Jeong","doi":"10.1177/0092861512436841","DOIUrl":"https://doi.org/10.1177/0092861512436841","url":null,"abstract":"This cross-sectional survey of 533 clinical research coordinators (CRCs) investigated working conditions, CRCs’ perceptions of their jobs, job satisfaction, and CRCs’ intentions to stay at their jobs in the Republic of Korea. Only 11.3% of CRCs hold full-time positions, and 37.9% have an annual salary of US$13,055–$17,406. The average perception of 20 job attributes was 3.14 points on a 5-point scale; interest in job (3.90 points) ranked the highest, while promotion possibility (1.97 points) was the lowest. Seven factors related to job satisfaction were identified as a result of multiple logistic regression analysis: variety (OR = 2.24), interest in job (OR = 4.26), job stress (OR = 2.00), salary (OR = 2.85), influence (OR = 2.03), work value (OR = 2.24), and job security (OR = 3.01). The factors related to CRCs’ intentions to stay at their jobs were variety (OR = 2.12), interest in job (OR = 4.49), work hours (OR = 2.12), and job security (OR = 3.45). According to the results, CRCs were interested in their jobs and evaluated their jobs as important and worthwhile; they also showed high job satisfaction and an intention to stay at their jobs. Therefore, it is recommended that various efforts be made to maintain the current status of CRCs and to improve their job stability and salary, so that they remain CRCs for longer.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129675229","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":"On the Importance of a Single Data Standard","authors":"Richard C. Zink, Geoffrey Mann","doi":"10.1177/0092861512441101","DOIUrl":"https://doi.org/10.1177/0092861512441101","url":null,"abstract":"The Clinical Data Interchange Standards Consortium (CDISC) has developed standards for data models, study design, and supporting clinical trial documents. CDISC standards have made such gains that the Center for Drug Evaluation and Research strongly encourages their use and implementation for submission of drug applications. However, despite the advances and improvements in these standards over the years and the ever-looming threat that they may someday be a requirement for drug applications, many are skeptical of a single standard and fail to understand the far-reaching advantages of adopting it. In this article we address the concerns and present numerous tangible benefits of CDISC standards.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116575174","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 Physician Payments Sunshine Act: A Setback for Medical Progress","authors":"M. Weber","doi":"10.1177/0092861512442022","DOIUrl":"https://doi.org/10.1177/0092861512442022","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115913306","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":"Online FDA Resources Versus Data on File: Minimizing Data on File in Standard Medical Response Letters","authors":"Nancy Hwang, Angie S. Graham, Marbel Catolico","doi":"10.1177/0092861512440849","DOIUrl":"https://doi.org/10.1177/0092861512440849","url":null,"abstract":"Background Reviewers’ summaries and other documents routinely posted on the FDA website have been cited in published studies and by tertiary drug information resources. Because they can contain information otherwise undisclosed to the public, they could potentially replace certain data on file references in standard medical response letters. Objective The purpose of this study was to evaluate whether publicly available information from the FDA website ( https://doi.org/www.fda.gov ) could reduce the need to use data on file as a reference in industry drug information service standard response letters. Methods Eighty-six standard response letters for 4 drug products, containing 272 data on file references, were assessed to determine whether data on file could be replaced using online FDA medical reviews or advisory committee briefing documents. Results Thirty-two percent (87/272) of data on file references were found to be replaceable with existing information on the FDA website. Conclusions Online FDA resources may sometimes be used in lieu of data on file in standard medical response letters.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124093632","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":"Source Data Verification by Statistical Sampling: Issues in Implementation","authors":"A. Grieve","doi":"10.1177/0092861512442057","DOIUrl":"https://doi.org/10.1177/0092861512442057","url":null,"abstract":"Efficiency of the drug development process is a continuing concern for pharmaceutical companies, governments, regulatory authorities, and patients. While much time and effort have been spent on developments in genetics and on sophisticated statistical designs, there has been less concern about the processes that govern the running of clinical trials. In this article, I describe a statistical method for source data verification whose implementation can have a large impact on the workload of trial monitors. I investigate the consequences of a less stringent form of source data verification on the quality of data and the inferences that can be drawn from the data.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116774786","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":"Contraception Language in Informed Consent Forms: A Survey of Biopharmaceutical Companies","authors":"E. Ng, P. Chiruvolu, Gweneth Levy, B. Allan, D. Wyszynski","doi":"10.1177/0092861512438747","DOIUrl":"https://doi.org/10.1177/0092861512438747","url":null,"abstract":"Although contraception language is typically required in subject informed consent forms (ICFs) used in clinical trials, there are no regulatory guidelines on the type and duration of methods of contraception that should be used. The authors conducted an anonymous 3-part survey to assess what contraception language biopharmaceutical companies use in their ICFs as well as the staff composition of the companies’ pharmacovigilance teams dealing with pregnancy and lactation. The majority of the companies sponsor clinical trials involving either small molecules (drugs) or a mix of small and large (biologics) molecules. The survey showed notably different answers between companies. Also, only a few companies have staff specifically dedicated to overseeing the enrollment of women of childbearing potential and following their progress if they become pregnant. The findings from this survey indicate that there is little uniformity among biopharmaceutical companies with respect to the contraception language included in ICFs.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128039292","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 Translational Medicine and Drug Discovery\u0000","authors":"E. Tabor","doi":"10.1177/0092861512436757","DOIUrl":"https://doi.org/10.1177/0092861512436757","url":null,"abstract":"Although the term ‘‘translational research’’ first appeared in PubMed in 1993, it was not widely used until about 2000. Attention to it has surged since then in response to the discovery of new biomarkers and, more recently, to advances in biomarkers research. As a result of this trend, this book, Translational Medicine and Drug Discovery, is really about the role of biomarkers in translational research. A good biomarker can allow investigators to select patients for a targeted approach to treatment, increasing the chances that a study will have a successful outcome if the treatment is effective. A good biomarker also can shorten the time to completion of clinical (or nonclinical) studies, by permitting the early detection of safety or efficacy, or lack thereof. The need to validate biomarkers, to show their clinical relevance, is an important part of preparing to use them in clinical studies, and sometimes the validation can be incorporated in the first clinical study with the biomarker, establishing its usefulness for future studies as well. A philosophy of using biomarkers to build a program of drug discovery is described in one chapter of the book, written by a Merck executive. Merck has used biomarkers to develop targeted therapies, to reduce the length of clinical Phases 1 and 2 (Merck claims to have reduced the time from the industry average of 3.7 years to 2.5 years), and to identify sooner those products that will not make it past Phase 2. A culture was created in which a ‘‘failed’’ trial or program was considered really to be a success if the failure occurred early enough to allow the advancement of better programs. Their slogan is ‘‘Fail Fast, Fail Cheap,’’ and biomarkers have made this possible. The core chapters of the book address translational medicine and biomarkers in each of several diseases or conditions, and these chapters make this book valuable. They cover diabetes mellitus, atherosclerosis, obesity, bone disorders, neuroscience, and oncology. There is also an extensive chapter on ‘‘imaging biomarkers.’’ I found the core chapter on translational medicine in diabetes mellitus to be particularly good. In studying anti-diabetic medications in normal volunteers in Phase 1, it is not possible to observe a glucose-dependant lowering of blood glucose since normal volunteer subjects are not hyperglycemic. However, biomarkers can allow one to study proof-of-mechanism in these normal subjects, to get a preliminary indication of activity of the molecule in humans at an early stage of development. This approach was used successfully in the development of DPP-4i drugs by measuring the effects of the drugs on DPP-4 activity in healthy volunteers, and validating this in later studies as a marker for the effect the drug would have on the glucose levels of hyperglycemic patients. One unusual chapter consists of the full text of a 2004 Pfizer document on biomarker validation and use, which defines the terms that are used in biomarker studies,","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"39 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":"124965203","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":"Consumer Dynamics in a Nonmature Generic Drugs Market: A Causal Model Explaining Intention to Purchase in Spain","authors":"M. Gómez, Mercedes Rozano","doi":"10.1177/0092861511435907","DOIUrl":"https://doi.org/10.1177/0092861511435907","url":null,"abstract":"Governments concerned with the rising cost of pharmaceuticals are striving to promote the use of generic drugs. To develop nonmature markets, demand-side policies are essential in considering the consumer’s active role in the decision-making process. Our model studies the causal relationships influencing consumer purchase intention, including perceived risk, experience, and information provided by a physician and pharmacist as antecedents. The main results of a survey of 560 individuals indicate that perceived risk and experience directly influence the purchase motivation. Experience reduces the risk and physicians’ advice slightly increases perceived risk. Market developers of generic drugs should coordinate strategies to include the 3 agents involved (physicians, pharmacists, and consumers) to decrease perceived risk and thereby increase consumer trust in generic drugs.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"32 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":"128684778","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}