Pub Date : 2021-03-01DOI: 10.54920/scto.2021.rawatch.5.20
Patient organisations support and advocate for the patient communities they represent while also increasing the role of patients in improving and shaping healthcare practices, policies, and systems. During the coronavirus pandemic, patient organisations have provided their patient communities with relevant information on COVID-19 and have brought patients’ perspectives into the dialogue around COVID-19. Moreover, they have advocated for patients’ needs and concerns related to the pandemic’s effects on human research and to coronavirus vaccine development and authorisation. This article summarises several of the issues facing patient communities during the pandemic and provides examples of patient organisations’ responses to these issues.
{"title":"Patient organisations: COVID-19 concerns related to human research","authors":"","doi":"10.54920/scto.2021.rawatch.5.20","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.20","url":null,"abstract":"Patient organisations support and advocate for the patient communities they represent while also increasing the role of patients in improving and shaping healthcare practices, policies, and systems. During the coronavirus pandemic, patient organisations have provided their patient communities with relevant information on COVID-19 and have brought patients’ perspectives into the dialogue around COVID-19. Moreover, they have advocated for patients’ needs and concerns related to the pandemic’s effects on human research and to coronavirus vaccine development and authorisation. This article summarises several of the issues facing patient communities during the pandemic and provides examples of patient organisations’ responses to these issues.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125562980","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 : 2021-03-01DOI: 10.54920/scto.2021.rawatch.5.13
Irène Knüsel, Stéphanie Wyss, Pascal Walther, Marc Zbinden
As the foremost research funding organisation in Switzerland, the Swiss National Science Foundation (SNSF) plays a key role in promoting scientific research in Switzerland. In 2019, the SNSF supported 18,900 researchers with over 1 billion Swiss francs in order to promote research that benefits society, the economy, and politics. All three of these areas have been dramatically affected by the COVID-19 pandemic – with profound national and inter- national consequences. This article provides an overview of the SNSF’s national and international responses to the pandemic, discusses the challenges the SNSF has faced during the pandemic, and highlights lessons learnt so far.
{"title":"Supporting research during the pandemic: How the Swiss National Science Foundation has responded to COVID-19","authors":"Irène Knüsel, Stéphanie Wyss, Pascal Walther, Marc Zbinden","doi":"10.54920/scto.2021.rawatch.5.13","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.13","url":null,"abstract":"As the foremost research funding organisation in Switzerland, the Swiss National Science Foundation (SNSF) plays a key role in promoting scientific research in Switzerland. In 2019, the SNSF supported 18,900 researchers with over 1 billion Swiss francs in order to promote research that benefits society, the economy, and politics. All three of these areas have been dramatically affected by the COVID-19 pandemic – with profound national and inter- national consequences. This article provides an overview of the SNSF’s national and international responses to the pandemic, discusses the challenges the SNSF has faced during the pandemic, and highlights lessons learnt so far.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"68 31","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120887083","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 : 2021-03-01DOI: 10.54920/scto.2021.rawatch.5.10
Madeleine Vollmer, Claudia Becherer
The pandemic hit us all much faster and to a larger extent than we could have imagined. We have had to find strategies for adapting quickly to the circumstances on both private and business levels. The Department of Clinical Research (DKF) at the University Hospital Basel (USB) has developed work practices for how to reconcile home office and work, how to handle frequently updated guidelines, and how to respond to questions from researchers about their clinical trials. In this article, we summarise nine DKF work practices and discuss lessons learnt during the corona crisis.
{"title":"COVID: 1–9 work practices and lessons learnt at one CTU","authors":"Madeleine Vollmer, Claudia Becherer","doi":"10.54920/scto.2021.rawatch.5.10","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.10","url":null,"abstract":"The pandemic hit us all much faster and to a larger extent than we could have imagined. We have had to find strategies for adapting quickly to the circumstances on both private and business levels. The Department of Clinical Research (DKF) at the University Hospital Basel (USB) has developed work practices for how to reconcile home office and work, how to handle frequently updated guidelines, and how to respond to questions from researchers about their clinical trials. In this article, we summarise nine DKF work practices and discuss lessons learnt during the corona crisis.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"244 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134274667","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 : 2021-03-01DOI: 10.54920/scto.2021.rawatch.5.17
{"title":"The role of swissethics and ethics committees during the COVID-19 pandemic","authors":"","doi":"10.54920/scto.2021.rawatch.5.17","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.17","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125149126","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.23
Elke Hiendlmeyer
Every day, more and more health data are captured and documented electronically instead of in stacks of printouts, as it often once was. The near future promises a full transition from paper to electronic records. This digital progress is felt far beyond the initial steps of capturing patient records, however. Health data are a fundamental building block of clinical trials. So the practices of how data are selected and collected are closely linked to the regulatory requirements of clinical trials and how these trials will be run from an operational standpoint.
{"title":"A national survey on the use of EHR systems in clinical research","authors":"Elke Hiendlmeyer","doi":"10.54920/scto.2021.rawatch.4.23","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.23","url":null,"abstract":"Every day, more and more health data are captured and documented electronically instead of in stacks of printouts, as it often once was. The near future promises a full transition from paper to electronic records. This digital progress is felt far beyond the initial steps of capturing patient records, however. Health data are a fundamental building block of clinical trials. So the practices of how data are selected and collected are closely linked to the regulatory requirements of clinical trials and how these trials will be run from an operational standpoint.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117081675","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.12
A. Nienhaus
{"title":"Towards a national strategy for registries and cohorts","authors":"A. Nienhaus","doi":"10.54920/scto.2021.rawatch.4.12","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.12","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130976096","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.20
Interview with Julia Parafita, project leader for data registries, medical direction, CHUV
访谈Julia Parafita, CHUV医学方向数据注册项目负责人
{"title":"Medical registries: An illustration of how governance works at the university hospital level","authors":"","doi":"10.54920/scto.2021.rawatch.4.20","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.20","url":null,"abstract":"Interview with Julia Parafita, project leader for data registries, medical direction, CHUV","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133288656","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.17
Philipp do Canto
Since its foundation in 1959, the Swiss Multiple Sclerosis Society (Swiss MS Society) has been supporting people living with multiple sclerosis (MS) in their daily lives. The organisation also provides funding for scientific research and serves as an independent platform for information related to MS. The quest to better understand MS and ultimately find its cure has always been a driver for innovation. Seizing the opportunities created by the emergence of data-driven medicine, the Swiss MS Society created the Swiss MS Registry – the first health registry in Switzerland owned exclusively by a patient organisation.
自1959年成立以来，瑞士多发性硬化症协会(Swiss MS Society)一直在日常生活中支持多发性硬化症(MS)患者。该组织还为科学研究提供资金，并作为一个与多发性硬化症相关的独立信息平台。寻求更好地了解多发性硬化症并最终找到治疗方法一直是创新的动力。抓住数据驱动医学的出现所带来的机遇，瑞士多发性硬化症协会创建了瑞士多发性硬化症登记处，这是瑞士第一个由患者组织独家拥有的健康登记处。
{"title":"Swiss Multiple Sclerosis Registry: A landmark project for citizen science","authors":"Philipp do Canto","doi":"10.54920/scto.2021.rawatch.4.17","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.17","url":null,"abstract":"Since its foundation in 1959, the Swiss Multiple Sclerosis Society (Swiss MS Society) has been supporting people living with multiple sclerosis (MS) in their daily lives. The organisation also provides funding for scientific research and serves as an independent platform for information related to MS. The quest to better understand MS and ultimately find its cure has always been a driver for innovation. Seizing the opportunities created by the emergence of data-driven medicine, the Swiss MS Society created the Swiss MS Registry – the first health registry in Switzerland owned exclusively by a patient organisation.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"30 6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124326035","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.4
Elke Hiendlmeyer, F. Jörger
Registries provide important real-world data about public health and thus have a major impact on far-reaching political health decisions and medical patient care. In addition, registries contribute to transparency and comparability of medical services and are the basis for epidemiological and clinical research. Last but not least, they play a key role for quality assurance and the development of medical services (Mathis-Edenhofer and Piso 2011). It is therefore hardly surprising that the number of registries in Switzerland is steadily increasing. In order to effectively operate registries and use them for research purposes, it is essential to ensure the quality of the collected data and their compliance with regulatory requirements. This article provides an overview of medical registries by discussing four related questions.
{"title":"Medical registries and their use for research projects","authors":"Elke Hiendlmeyer, F. Jörger","doi":"10.54920/scto.2021.rawatch.4.4","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.4","url":null,"abstract":"Registries provide important real-world data about public health and thus have a major impact on far-reaching political health decisions and medical patient care. In addition, registries contribute to transparency and comparability of medical services and are the basis for epidemiological and clinical research. Last but not least, they play a key role for quality assurance and the development of medical services (Mathis-Edenhofer and Piso 2011). It is therefore hardly surprising that the number of registries in Switzerland is steadily increasing. In order to effectively operate registries and use them for research purposes, it is essential to ensure the quality of the collected data and their compliance with regulatory requirements. This article provides an overview of medical registries by discussing four related questions.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114645629","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 : 2020-10-01DOI: 10.54920/scto.2021.rawatch.4.14
Nicole Steck, M. Zwahlen, A. Spoerri
With the increasing use of implantable medical devices, registries are critical for conducting post-market surveillance and identifying long-term safety risks. Switzerland’s national implant registry SIRIS is an outstanding example of the benefits a well-managed registry can provide to different players in healthcare. The SIRIS registry also illustrates how to ensure high-quality registry data.
{"title":"Using medical registries: Switzerland’s implant registry SIRIS as a successful model","authors":"Nicole Steck, M. Zwahlen, A. Spoerri","doi":"10.54920/scto.2021.rawatch.4.14","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.4.14","url":null,"abstract":"With the increasing use of implantable medical devices, registries are critical for conducting post-market surveillance and identifying long-term safety risks. Switzerland’s national implant registry SIRIS is an outstanding example of the benefits a well-managed registry can provide to different players in healthcare. The SIRIS registry also illustrates how to ensure high-quality registry data.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131530262","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}
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