Pub Date : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.25
L. H. Nielsen, Jose Benito Gonzalez Lopez, Tim Smith, Alexandros Ioannidis
Properly managing, preserving, and sharing data can be a daunting task, especially for busy researchers who are constantly confronted with new tasks and requirements from funders and their institutions. Zenodo is a general-purpose data repository that enables researchers, scientists, project managers, and institutions to share, preserve, and showcase multidisciplinary research results (data, software, publications, and other research objects) that are outside the scope of existing institutional or subject-based repositories. Based in the trustworthy CERN data centre, Zenodo is a service provided by researchers to researchers contributing to open science by capturing research objects and making them FAIR (findable, accessible, interoperable, and reusable). This article addresses some of the challenges of data storage and data sharing, such as finding the right place to store data, citing data properly, and using hybrid data sharing solutions. It also demonstrates how using a data repository like Zenodo can help researchers address these challenges.
{"title":"Zenodo data repository: Providing practical solutions for data storage and data sharing","authors":"L. H. Nielsen, Jose Benito Gonzalez Lopez, Tim Smith, Alexandros Ioannidis","doi":"10.54920/scto.2022.rawatch.7.25","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.25","url":null,"abstract":"Properly managing, preserving, and sharing data can be a daunting task, especially for busy researchers who are constantly confronted with new tasks and requirements from funders and their institutions. Zenodo is a general-purpose data repository that enables researchers, scientists, project managers, and institutions to share, preserve, and showcase multidisciplinary research results (data, software, publications, and other research objects) that are outside the scope of existing institutional or subject-based repositories. Based in the trustworthy CERN data centre, Zenodo is a service provided by researchers to researchers contributing to open science by capturing research objects and making them FAIR (findable, accessible, interoperable, and reusable). This article addresses some of the challenges of data storage and data sharing, such as finding the right place to store data, citing data properly, and using hybrid data sharing solutions. It also demonstrates how using a data repository like Zenodo can help researchers address these challenges.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124086108","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 : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.12
Eva Brombacher, Virgilia Rumetsch
Over the past few years, Switzerland has seen a marked increase in the further use of routine clinical data, research data, and biological materials for research purposes. This article aims to shed some light on a few typical problems the cantonal ethics committee of Zurich encounters in the area of the further use of biological material and patient data for research with or without consent. Other difficult questions may arise in emergency situations, in the evaluation of sample size and pre-screening patients for clinical studies, and in situations when a patient revokes consent.
{"title":"Further use of data in research: Current trends, legal background, and typical problems","authors":"Eva Brombacher, Virgilia Rumetsch","doi":"10.54920/scto.2022.rawatch.7.12","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.12","url":null,"abstract":"Over the past few years, Switzerland has seen a marked increase in the further use of routine clinical data, research data, and biological materials for research purposes. This article aims to shed some light on a few typical problems the cantonal ethics committee of Zurich encounters in the area of the further use of biological material and patient data for research with or without consent. Other difficult questions may arise in emergency situations, in the evaluation of sample size and pre-screening patients for clinical studies, and in situations when a patient revokes consent.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125213663","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 : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.22
M. Engelhard
Sharing health data in a meaningful way that preserves privacy is the foundation of a well-functioning digital health data ecosystem. A digital ecosystem implies that stakeholders are embedded in the necessary conditions to collect, store, share, and use health data electronically. Health data ecosystems can provide many benefits to society, including effective personalised medicine for patients, greater innovation in research, and improved policymaking. As an integral part of these health data ecosystems, the pharmaceutical industry already contributes substantially to them by investing in and sharing health data in order to facilitate medical progress. While many countries have recognised the value of health data ecosystems, Switzerland lags massively behind when it comes to secondary health data usage. To change this, Switzerland needs to develop a coherent strategy to create a health data ecosystem involving all relevant stakeholders.
{"title":"Health data ecosystems: Sharing health data to facilitate medical progress","authors":"M. Engelhard","doi":"10.54920/scto.2022.rawatch.7.22","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.22","url":null,"abstract":"Sharing health data in a meaningful way that preserves privacy is the foundation of a well-functioning digital health data ecosystem. A digital ecosystem implies that stakeholders are embedded in the necessary conditions to collect, store, share, and use health data electronically. Health data ecosystems can provide many benefits to society, including effective personalised medicine for patients, greater innovation in research, and improved policymaking. As an integral part of these health data ecosystems, the pharmaceutical industry already contributes substantially to them by investing in and sharing health data in order to facilitate medical progress. While many countries have recognised the value of health data ecosystems, Switzerland lags massively behind when it comes to secondary health data usage. To change this, Switzerland needs to develop a coherent strategy to create a health data ecosystem involving all relevant stakeholders.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"97 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131387713","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}
Since entering into force in 2014, the Human Research Act (HRA) and its ordinances have provided the regulatory framework in Switzerland for accessing health-related personal data and biological material for the purposes of research related to human diseases and to the structure and functioning of the human body. This legislation aims to protect participants’ privacy. At the same time, the scientific community wants to generate knowledge. Aside from the HRA, data privacy in Switzerland is more widely covered by the Federal Act on Data Protection (FADP) and in some cases by the EU’s General Data Protection Regulation (GDPR). When preparing and conducting a clinical study, researchers have to comply with a number of requirements and guidelines in order to respect the rights of patients (i.e. data privacy) and fulfil their duties to the scientific community (i.e. data sharing). This article discusses how these statutory requirements apply to specific clinical study documents, processes, and tools.
{"title":"Data privacy and data sharing within the regulatory framework governing human, health-related research in Switzerland","authors":"Samantha Chan, Hélène Maby-El Hajjami, Sonia Carboni, Isabelle Guilleret, Denis Falcetta, Claudia Becherer","doi":"10.54920/scto.2022.rawatch.7.4","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.4","url":null,"abstract":"Since entering into force in 2014, the Human Research Act (HRA) and its ordinances have provided the regulatory framework in Switzerland for accessing health-related personal data and biological material for the purposes of research related to human diseases and to the structure and functioning of the human body. This legislation aims to protect participants’ privacy. At the same time, the scientific community wants to generate knowledge. Aside from the HRA, data privacy in Switzerland is more widely covered by the Federal Act on Data Protection (FADP) and in some cases by the EU’s General Data Protection Regulation (GDPR). When preparing and conducting a clinical study, researchers have to comply with a number of requirements and guidelines in order to respect the rights of patients (i.e. data privacy) and fulfil their duties to the scientific community (i.e. data sharing). This article discusses how these statutory requirements apply to specific clinical study documents, processes, and tools.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126803025","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.4
Deborah Eberle, Marie Mi Bonde Hansen, Anouk Fricker, Marina Roggo
Patient and public involvement (PPI) describes the active engagement of patients and the public in different aspects of clinical research. This Deep Dive article covers the current situation of PPI in academic clinical research in Switzerland, giving examples of local support and initiatives that are currently offered by university hospital clinical trial units (CTUs) and also addressing the lack of legislation related to PPI. In addition, it provides an overview of data protection regulations to be considered when working with data generated during PPI and ends with a discussion of the key issues related to PPI in Switzerland.
{"title":"Regulatory aspects of patient and public involvement in academic clinical research in Switzerland","authors":"Deborah Eberle, Marie Mi Bonde Hansen, Anouk Fricker, Marina Roggo","doi":"10.54920/scto.2021.rawatch.6.4","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.4","url":null,"abstract":"Patient and public involvement (PPI) describes the active engagement of patients and the public in different aspects of clinical research. This Deep Dive article covers the current situation of PPI in academic clinical research in Switzerland, giving examples of local support and initiatives that are currently offered by university hospital clinical trial units (CTUs) and also addressing the lack of legislation related to PPI. In addition, it provides an overview of data protection regulations to be considered when working with data generated during PPI and ends with a discussion of the key issues related to PPI in Switzerland.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122127133","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.29
M. Tapernoux, Claudio Bassetti, H. Bounameaux
What does clinical research in Switzerland need in order to increase its benefit to patients and society? What changes are necessary? This year, the Swiss Academy of Medical Sciences (SAMS) published its White Paper: Clinical Research, which formulates seven goals that bring together clinical research stakeholders around a shared vision. This vision – to strengthen the impact of clinical research – is based on a solid partnership with patients and the public.
{"title":"Towards integrative, patient-centred clinical research","authors":"M. Tapernoux, Claudio Bassetti, H. Bounameaux","doi":"10.54920/scto.2021.rawatch.6.29","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.29","url":null,"abstract":"What does clinical research in Switzerland need in order to increase its benefit to patients and society? What changes are necessary? This year, the Swiss Academy of Medical Sciences (SAMS) published its White Paper: Clinical Research, which formulates seven goals that bring together clinical research stakeholders around a shared vision. This vision – to strengthen the impact of clinical research – is based on a solid partnership with patients and the public.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"90 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115945445","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.33
Marie Mi Bonde Hansen
Because of their lived experience, patients provide unique insights and perspectives on clinical research studies. This article presents two case studies from the University Hospital Basel that illustrate how researchers and patients can collaborate to shape research priorities and study design as well as assess study feasibility.
{"title":"The valuable insights of patients: Two case studies","authors":"Marie Mi Bonde Hansen","doi":"10.54920/scto.2021.rawatch.6.33","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.33","url":null,"abstract":"Because of their lived experience, patients provide unique insights and perspectives on clinical research studies. This article presents two case studies from the University Hospital Basel that illustrate how researchers and patients can collaborate to shape research priorities and study design as well as assess study feasibility.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131838121","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.31
Tourane Corbière, N. Elia, Sonia Carboni
While the concept of patients as partners in clinical research is becoming increasingly prevalent, there is still room for improvement. The development and validation of partnership models to engage patients in the design and governance of clinical research programmes are still in the early stages, and approaches that can ensure substantial and effective patient contributions to research are needed. In this article, we describe the patient partnership model being developed at Geneva University Hospitals (HUG) to engage patients and their caregivers in the design of clinical research studies and to encourage research groups in their efforts to involve patients within their teams.
{"title":"Patient engagement in clinical research: Geneva University Hospitals’ model","authors":"Tourane Corbière, N. Elia, Sonia Carboni","doi":"10.54920/scto.2021.rawatch.6.31","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.31","url":null,"abstract":"While the concept of patients as partners in clinical research is becoming increasingly prevalent, there is still room for improvement. The development and validation of partnership models to engage patients in the design and governance of clinical research programmes are still in the early stages, and approaches that can ensure substantial and effective patient contributions to research are needed. In this article, we describe the patient partnership model being developed at Geneva University Hospitals (HUG) to engage patients and their caregivers in the design of clinical research studies and to encourage research groups in their efforts to involve patients within their teams.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114191429","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.17
It has been widely proven that involving patients and laypeople throughout the entire human research process provides added value for human research in general, for patients in their everyday lives, and therefore for society as a whole. Public and patient involvement (PPI) is possible at the very early stages of research when defining objectives and planning a study, when a study is conducted, and when study results are published. PPI means that patients are treated as active research partners rather than just passive research subjects. This article discusses how swissethics promotes transparency in order to lay the foundation of trust needed for PPI and provides examples of PPI for the regulatory and ethical aspects of human research.
{"title":"swissethics: Building trust and including patients’ perspectives in the human research process","authors":"","doi":"10.54920/scto.2021.rawatch.6.17","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.17","url":null,"abstract":"It has been widely proven that involving patients and laypeople throughout the entire human research process provides added value for human research in general, for patients in their everyday lives, and therefore for society as a whole. Public and patient involvement (PPI) is possible at the very early stages of research when defining objectives and planning a study, when a study is conducted, and when study results are published. PPI means that patients are treated as active research partners rather than just passive research subjects. This article discusses how swissethics promotes transparency in order to lay the foundation of trust needed for PPI and provides examples of PPI for the regulatory and ethical aspects of human research.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134005506","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 : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.14
Carolin von Schoultz, Deborah Studer, M. Korneli
Since 2016, the Swiss National Science Foundation (SNSF) has been funding investigator-initiated clinical trials (IICTs) on topics that lie outside of industry focus but are of significance to society. This year, patient and public representatives actively participated in the evaluation of applications submitted to this programme for the first time, a measure that has been overdue at the SNSF when compared to other European funders. The inclusion of the patient’s perspective to “standard” clinical and statistical assessments added value to the evaluation and was an eye-opening experience for everyone involved.
{"title":"Giving patients and the public a voice in evaluating funding applications for clinical trials","authors":"Carolin von Schoultz, Deborah Studer, M. Korneli","doi":"10.54920/scto.2021.rawatch.6.14","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.14","url":null,"abstract":"Since 2016, the Swiss National Science Foundation (SNSF) has been funding investigator-initiated clinical trials (IICTs) on topics that lie outside of industry focus but are of significance to society. This year, patient and public representatives actively participated in the evaluation of applications submitted to this programme for the first time, a measure that has been overdue at the SNSF when compared to other European funders. The inclusion of the patient’s perspective to “standard” clinical and statistical assessments added value to the evaluation and was an eye-opening experience for everyone involved.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"83 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114179324","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：