Pub Date : 2016-10-01DOI: 10.3109/10601333.2016.1151610
S. Mimica Matanović
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.
{"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":"1 1","pages":"49 - 58"},"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}
Pub Date : 2016-07-26DOI: 10.1080/10601333.2016.1210159
Dillan Bono-Lunn, Chantal Villeneuve, Nour J Abdulhay, M. Harker, W. Parker
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.
{"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":"1 1","pages":"39 - 48"},"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}
Pub Date : 2016-05-01DOI: 10.1080/10601333.2016.1176301
Maria Duarte, Paula Ferreira, M. A. Soares, A. Martins, A. Cavaco
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.
{"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":"35 1","pages":"33 - 38"},"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}
Pub Date : 2016-03-16DOI: 10.3109/10601333.2016.1152661
Daniela Drago, M. Yap, O. Ekmekci
Abstract In today’s globalized drug development landscape, the need for regulatory professionals to be more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the benefit of involving regulatory affairs professionals in strategic business decisions, many still lag behind. Limited literature and scholarly discussion is available on whether regulatory affairs professionals are given the stature and power to make a meaningful contribution during strategy formulation across all stages of the product development, launch, and life-cycle management. This article examines the current business environment for the regulated industries; discusses why it is important that regulatory affairs play an active and strategic role in this sector; and proposes a new educational perspective to facilitate the recognition and acceptance of regulatory affairs professionals as strategic partners.
{"title":"Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners","authors":"Daniela Drago, M. Yap, O. Ekmekci","doi":"10.3109/10601333.2016.1152661","DOIUrl":"https://doi.org/10.3109/10601333.2016.1152661","url":null,"abstract":"Abstract In today’s globalized drug development landscape, the need for regulatory professionals to be more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the benefit of involving regulatory affairs professionals in strategic business decisions, many still lag behind. Limited literature and scholarly discussion is available on whether regulatory affairs professionals are given the stature and power to make a meaningful contribution during strategy formulation across all stages of the product development, launch, and life-cycle management. This article examines the current business environment for the regulated industries; discusses why it is important that regulatory affairs play an active and strategic role in this sector; and proposes a new educational perspective to facilitate the recognition and acceptance of regulatory affairs professionals as strategic partners.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"29 1","pages":"59 - 65"},"PeriodicalIF":0.0,"publicationDate":"2016-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78349145","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}
Pub Date : 2016-01-02DOI: 10.3109/10601333.2016.1117096
J. Finley
Abstract ‘Nutraceuticals’ are a category of substances without a legal definition, often sold as dietary supplements or components of conventional foods. Nutraceuticals are considered to impart health benefits beyond ordinary nutrition; many nutraceuticals do improve health, but for others evidence is often equivocal or based on animal and/or in vitro data. Moreover, evidence that a component of a substance in a food has a beneficial effect often does not translate into benefits of a substance that has been isolated and consumed in greater quantities. Increasing regulatory requirements from multiple government agencies complicate the design, testing, and marketing of these substances. Dietary advice also is contradictory to much of the marketing of nutraceuticals as it emphasizes using whole foods and ensuring that the overall diet is adequate, rather than focusing on individual components. How the nutraceutical industry responds to these changing conditions will determine the health and growth of the industry over the coming decade(s).
{"title":"The nutraceutical revolution: Emerging vision or broken dream? Understanding scientific and regulatory concerns","authors":"J. Finley","doi":"10.3109/10601333.2016.1117096","DOIUrl":"https://doi.org/10.3109/10601333.2016.1117096","url":null,"abstract":"Abstract ‘Nutraceuticals’ are a category of substances without a legal definition, often sold as dietary supplements or components of conventional foods. Nutraceuticals are considered to impart health benefits beyond ordinary nutrition; many nutraceuticals do improve health, but for others evidence is often equivocal or based on animal and/or in vitro data. Moreover, evidence that a component of a substance in a food has a beneficial effect often does not translate into benefits of a substance that has been isolated and consumed in greater quantities. Increasing regulatory requirements from multiple government agencies complicate the design, testing, and marketing of these substances. Dietary advice also is contradictory to much of the marketing of nutraceuticals as it emphasizes using whole foods and ensuring that the overall diet is adequate, rather than focusing on individual components. How the nutraceutical industry responds to these changing conditions will determine the health and growth of the industry over the coming decade(s).","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"43 1","pages":"1 - 3"},"PeriodicalIF":0.0,"publicationDate":"2016-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78195573","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}
Pub Date : 2016-01-02DOI: 10.3109/10601333.2016.1127381
N. Mittal, Rakesh Mittal, M. Gupta
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.
{"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":"10 1","pages":"4 - 8"},"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}
Pub Date : 2016-01-02DOI: 10.3109/10601333.2016.1130717
N. Verma
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.
{"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":"38 1","pages":"24 - 9"},"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}
Pub Date : 2016-01-01Epub Date: 2016-06-01DOI: 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
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. .
{"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":"<p><strong>Context: </strong>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.</p><p><strong>Objective: </strong>We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results and discussion: </strong>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.</p><p><strong>Conclusions: </strong>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. .</p>","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"33 2-4","pages":"25-32"},"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}
Pub Date : 2015-10-02DOI: 10.3109/10601333.2015.1078809
Jing Zhang, Yiping Yuan
Abstract Clinical trials are the gold-standard means to evaluate the efficacy and safety of new drugs and other medical technologies. They can provide a scientific basis for treatment decisions for patients and their caregivers as well as sound reimbursement policies for governments and insurers. There has been a spectacular shift from government and academia to industry in the organization of clinical trials in the past decade. Currently, most of the trials are funded by industry and their research does make great contributions to the biomedical innovations, although limitations are inevitable. The finding that industry sponsorship is strongly associated with results that favor the experimental therapy brings concerns of sponsorship bias and quality issues to clinical trial results. However, existing research has its own limitations, and there is no solid evidence of causality. Industry-funded clinical trials are a two-edged sword, and further research on sponsorship bias is encouraged. A stronger regulatory policy and a new model of alliance between academia and industry are also imperative.
{"title":"Industry-funded clinical trials: Beneficial or harmful?","authors":"Jing Zhang, Yiping Yuan","doi":"10.3109/10601333.2015.1078809","DOIUrl":"https://doi.org/10.3109/10601333.2015.1078809","url":null,"abstract":"Abstract Clinical trials are the gold-standard means to evaluate the efficacy and safety of new drugs and other medical technologies. They can provide a scientific basis for treatment decisions for patients and their caregivers as well as sound reimbursement policies for governments and insurers. There has been a spectacular shift from government and academia to industry in the organization of clinical trials in the past decade. Currently, most of the trials are funded by industry and their research does make great contributions to the biomedical innovations, although limitations are inevitable. The finding that industry sponsorship is strongly associated with results that favor the experimental therapy brings concerns of sponsorship bias and quality issues to clinical trial results. However, existing research has its own limitations, and there is no solid evidence of causality. Industry-funded clinical trials are a two-edged sword, and further research on sponsorship bias is encouraged. A stronger regulatory policy and a new model of alliance between academia and industry are also imperative.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"46 1","pages":"109 - 112"},"PeriodicalIF":0.0,"publicationDate":"2015-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85322161","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}
Pub Date : 2015-09-18DOI: 10.3109/10601333.2015.1079217
T. Guetterman, M. Fetters, Laurie J. Legocki, Samkeliso Mawocha, W. Barsan, R. Lewis, D. Berry, W. Meurer
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.
本研究的背景是Adaptive Designs Advancing Promising therapies Into Trials (ADAPT-IT)项目，该项目旨在将灵活的适应性设计纳入关键临床试验，并对试验开发过程进行评估。很少有研究为学术机构规划适应性试验提供指导。本定性研究的目的是探讨利益相关者在反思交互式ADAPT-IT适应性设计开发过程时的观点和经验，并了解他们对试验设计和试验开发的经验教训的看法。作者对10个关键利益相关者进行了半结构化访谈，并对过程进行了观察。他们采用定性主题文本数据分析，将数据简化为ADAPT-IT项目和适应性临床试验的主题。定性分析揭示了四个主题:项目参与者的教育、参与者的反馈如何演变过程、可以促进其他试验发展的程序，以及对更广泛的研究界的教育。虽然参与者更有可能考虑灵活的适应性设计，但需要额外的教育来理解适应性方法并在计划试验时阐明它。
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