Clinical Research and Regulatory Affairs最新文献

Changes to protocol in the regulation of adverse drug reactions – historical and current European view 药物不良反应监管协议的变化-历史和当前欧洲的观点

Clinical Research and Regulatory Affairs Pub Date : 2016-10-01 DOI: 10.3109/10601333.2016.1151610

S. Mimica Matanović

{"title":"Changes to protocol in the regulation of adverse drug reactions – historical and current European view","authors":"S. Mimica Matanović","doi":"10.3109/10601333.2016.1151610","DOIUrl":"https://doi.org/10.3109/10601333.2016.1151610","url":null,"abstract":"Abstract Adverse drug reactions (ADRs) are an inevitable part of medication use. During clinical trials, limited information was gained on drug safety. After marketing authorization (MA), more safety data is available as more patients use the drug. Major changes in drug regulation came after drug disasters, like with sulphanilamide elixir or thalidomide use. In recent history, withdrawal of rofecoxib has demonstrated the importance of post-marketing safety monitoring. Subsequently, legislation on drug safety changed both in the United States (US) and in the European Union (EU), becoming simplified and more comprehensive. New EU legislation was implemented in 2012 and has broadened ADR definition to medication errors and overdoses. In the EU, the Pharmacovigilance Risk Assessment Committee (PRAC) has been formed within the European Medicines Agency (EMA), regulating all aspects of drug safety. Referral procedures enable a thorough scientific analysis on all issues of medication safety. In both the US and the EU, ADRs can be reported directly by patients. All reports of suspected ADRs are kept on electronic databases and are analyzed regularly using new technologies. New safety signals are subsequently discovered and evaluated. This author expects that the new regulations will effectively safeguard healthcare consumers from major drug risks.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81722074","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

Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships 鉴于人体作为一个“超级有机体”，包含多个相互交织的共生关系的政策和法规

Clinical Research and Regulatory Affairs Pub Date : 2016-07-26 DOI: 10.1080/10601333.2016.1210159

Dillan Bono-Lunn, Chantal Villeneuve, Nour J Abdulhay, M. Harker, W. Parker

{"title":"Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships","authors":"Dillan Bono-Lunn, Chantal Villeneuve, Nour J Abdulhay, M. Harker, W. Parker","doi":"10.1080/10601333.2016.1210159","DOIUrl":"https://doi.org/10.1080/10601333.2016.1210159","url":null,"abstract":"Abstract The human body is now understood to exist as an ecosystem that includes an abundance of life, called the human biome. For purposes of understanding and treating disease, the biome of the human ‘superorganism’ can be divided into three parts: human, microbial, and more complex organisms such as worms and protists. This paper examines medical progress with biome restorative practices, including fecal microbiota transplants and helminthic therapy, which have proven in some cases more effective and more economical at treating a wide range of diseases than pharmaceutical-based approaches. The regulatory and policy hurdles responsible in part for this limited use of these restorative practices are examined. More importantly, new approaches are encouraged which might reverse the general lack of interest for these restorative practices seen in the medical and biomedical research communities. Such approaches include the regulation of benign helminths as dietary supplements and the establishment of an Institute of Health focused on biome-related issues. Further, the formation of humanitarian organizations to produce and distribute products for biome restoration should be encouraged by public policy, mirroring the collection and distribution of blood and blood products by the Red Cross and Red Crescent Societies.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91205122","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: 11

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal 葡萄牙南部地区社区药剂师对风险管理计划的认识和看法

Clinical Research and Regulatory Affairs Pub Date : 2016-05-01 DOI: 10.1080/10601333.2016.1176301

Maria Duarte, Paula Ferreira, M. A. Soares, A. Martins, A. Cavaco

{"title":"Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal","authors":"Maria Duarte, Paula Ferreira, M. A. Soares, A. Martins, A. Cavaco","doi":"10.1080/10601333.2016.1176301","DOIUrl":"https://doi.org/10.1080/10601333.2016.1176301","url":null,"abstract":"Abstract A Risk Management Plan (RMP) is a detailed description of the activities and interventions designed to identify, characterize, prevent, or minimize risks relating to medicine’s use. The objective of this article is to assess RMP-related knowledge of community pharmacists and explore the reasons behind any potential issues with its use. This study has two focus points: (1) A cross-sectional survey within a sample of pharmacies in the area covered by the South Pharmacovigilance Center; and (2) a focus group (FG) with key-informants, in order to increase the explanatory scope of quantitative results. In total, 41.6% of the participants in the study knew what a risk management plan was, but 50% rated their knowledge as poor. According to focus group participants, this lack of knowledge seems to be related to three main factors: (i) this subject not being addressed during graduation training; (ii) professionals’ attitude; and (iii) lack of communication among different stakeholders. It is recommended that there is enhanced academic training in risk management. There is an important call for attitudinal change interventions and further investigation in monitoring RMP use and impact. A closer articulation between the regulator, the pharmaceutical society, associations, and industry is needed to promote and boost this topic among community pharmacists.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79292367","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

Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners 增加有效药物开发的几率:将监管事务专业人员提升为战略合作伙伴

Clinical Research and Regulatory Affairs Pub Date : 2016-03-16 DOI: 10.3109/10601333.2016.1152661

Daniela Drago, M. Yap, O. Ekmekci

引用次数: 2

The nutraceutical revolution: Emerging vision or broken dream? Understanding scientific and regulatory concerns 营养药品革命:新兴的愿景还是破碎的梦想?理解科学和监管方面的关注

Clinical Research and Regulatory Affairs Pub Date : 2016-01-02 DOI: 10.3109/10601333.2016.1117096

J. Finley

引用次数: 13

An overview of the pharmacovigilance system in India 印度药物警戒系统概述

Clinical Research and Regulatory Affairs Pub Date : 2016-01-02 DOI: 10.3109/10601333.2016.1127381

N. Mittal, Rakesh Mittal, M. Gupta

{"title":"An overview of the pharmacovigilance system in India","authors":"N. Mittal, Rakesh Mittal, M. Gupta","doi":"10.3109/10601333.2016.1127381","DOIUrl":"https://doi.org/10.3109/10601333.2016.1127381","url":null,"abstract":"Abstract Pharmacovigilance (PV) has witnessed several advancements throughout the world over the past few decades. This review provides an overview of the PV system in India, focusing on the current scenario, its development, the challenges faced, and the interventions suggested for its improvement. The Pharmacovigilance Program of India (PvPI) is playing a major role in gathering drug safety related data and adding it to the WHO database. PvPI fulfills the minimum requirements given by the WHO for any functional national Pharmacovigilance system. The Indian Pharmacopoeia Commission (IPC) is the national coordinating center under PvPI. PV in India relies mainly upon the spontaneous reporting of adverse drug events. The major challenge for PV in India is under-reporting. However, there is an improvement in the number of submitted reports after regular training and awareness programmes, which have been conducted by the IPC. The regular and periodic circulation of the ‘PvPI Newsletter’ by the IPC has also been instrumental in increasing awareness about PV amongst healthcare professionals and patients. The intensification of PV activities in India demands particular attention in health science curricula. Indeed, a change in mindset is necessary for prescribers, patients, regulatory agencies, and pharmaceutical companies.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90415109","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: 10

Current regulatory challenges and approaches in the registration of herbal drugs in Europe 当前欧洲草药注册的监管挑战和方法

Clinical Research and Regulatory Affairs Pub Date : 2016-01-02 DOI: 10.3109/10601333.2016.1130717

N. Verma

{"title":"Current regulatory challenges and approaches in the registration of herbal drugs in Europe","authors":"N. Verma","doi":"10.3109/10601333.2016.1130717","DOIUrl":"https://doi.org/10.3109/10601333.2016.1130717","url":null,"abstract":"Abstract Herbal medicines have formed the basis of healthcare worldwide since the earliest times and are still widely used. Recognition of their clinical, pharmaceutical, and economic value is still growing, although this varies widely between countries. Legislative controls in respect of medicinal plants have not evolved around a structured control model. There are different ways in which countries define medicinal plants or herbs or products derived from them, and countries have adopted various approaches to licensing, dispensing, manufacturing, and trading to ensure their safety, quality, and efficacy. The legal situation regarding herbal preparations varies from country to country. A critical problem in the evaluation of herbal drug products is the fact that they are complex mixtures of constituents and the constituents responsible for the therapeutics effects are unknown, which also complicates the stability of these products. A detailed literature survey of the current regulatory challenges and approaches in the registration of herbal drugs in Europe was performed to identify recently introduced changes in regulations or newly introduced regulations compliant with the regulatory bodies.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72943934","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

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure. 实用随机对照试验的招募经验：利用 EMR 计划，最大限度地减少研究基础设施。

Clinical Research and Regulatory Affairs Pub Date : 2016-01-01 Epub Date: 2016-06-01 DOI: 10.1080/10601333.2016.1182693

Christine Lm Joseph, Dennis R Ownby, Edward Zoratti, Dayna Johnson, Shannon Considine, Renee Bourgeois, Christina Melkonian, Cheryl Miree, Christine Cole Johnson, Mei Lu

{"title":"Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.","authors":"Christine Lm Joseph, Dennis R Ownby, Edward Zoratti, Dayna Johnson, Shannon Considine, Renee Bourgeois, Christina Melkonian, Cheryl Miree, Christine Cole Johnson, Mei Lu","doi":"10.1080/10601333.2016.1182693","DOIUrl":"10.1080/10601333.2016.1182693","url":null,"abstract":"Context: Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in \"real life\" settings.Objective: We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma.Materials and methods: Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention.Results and discussion: 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing.Conclusions: Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more \"explanatory\" framework. .","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5417689/pdf/nihms816460.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34975416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Industry-funded clinical trials: Beneficial or harmful? 行业资助的临床试验:有益还是有害?

Clinical Research and Regulatory Affairs Pub Date : 2015-10-02 DOI: 10.3109/10601333.2015.1078809

Jing Zhang, Yiping Yuan

引用次数: 3

Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process—Findings from a qualitative study 关于适应性设计加速有希望的治疗试验(ADAPT-IT)过程的思考——一项定性研究的结果

Clinical Research and Regulatory Affairs Pub Date : 2015-09-18 DOI: 10.3109/10601333.2015.1079217

T. Guetterman, M. Fetters, Laurie J. Legocki, Samkeliso Mawocha, W. Barsan, R. Lewis, D. Berry, W. Meurer

{"title":"Reflections on the adaptive designs accelerating promising trials into treatments (ADAPT-IT) process—Findings from a qualitative study","authors":"T. Guetterman, M. Fetters, Laurie J. Legocki, Samkeliso Mawocha, W. Barsan, R. Lewis, D. Berry, W. Meurer","doi":"10.3109/10601333.2015.1079217","DOIUrl":"https://doi.org/10.3109/10601333.2015.1079217","url":null,"abstract":"Abstract The context for this study was the Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project, which aimed to incorporate flexible adaptive designs into pivotal clinical trials and to conduct an assessment of the trial development process. Little research provides guidance to academic institutions in planning adaptive trials. The purpose of this qualitative study was to explore the perspectives and experiences of stakeholders as they reflected back about the interactive ADAPT-IT adaptive design development process, and to understand their perspectives regarding lessons learned about the design of the trials and trial development. The authors conducted semi-structured interviews with 10 key stakeholders, and observations of the process. They employed qualitative thematic text data analysis to reduce the data into themes about the ADAPT-IT project and adaptive clinical trials. The qualitative analysis revealed four themes: education of the project participants, how the process evolved with participant feedback, procedures that could enhance the development of other trials, and education of the broader research community. While participants became more likely to consider flexible adaptive designs, additional education is needed to both understand the adaptive methodology and articulate it when planning trials.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78679377","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: 11