Pub Date : 2021-10-01DOI: 10.54920/scto.2021.rawatch.6.36
Cordula Landgraf
Involving patients in academic clinical research ensures that research questions and clinical research outcomes are addressed and implemented in a manner relevant to patients. As one of our key strategic goals in the new 2021–2024 performance period, the Swiss Clinical Trial Organisation (SCTO) and its Clinical Trial Unit (CTU) Network are placing greater emphasis on the implementation of patient and public involvement (PPI) in academic clinical research. In pursuit of this strategic goal, the SCTO sent out a survey to relevant stakeholders in order to identify and characterise all PPI initiatives and projects in Switzerland and thereby establish the status quo. As a next step, the SCTO envisions establishing a central coordination and contact point that is pathology-independent and spans organisations. We aim for a sustainable, inclusive PPI approach in academic clinical research that is established in close collaboration with our partners and stakeholders.
{"title":"Involving patients in academic clinical research: It’s time to walk the talk","authors":"Cordula Landgraf","doi":"10.54920/scto.2021.rawatch.6.36","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.36","url":null,"abstract":"Involving patients in academic clinical research ensures that research questions and clinical research outcomes are addressed and implemented in a manner relevant to patients. As one of our key strategic goals in the new 2021–2024 performance period, the Swiss Clinical Trial Organisation (SCTO) and its Clinical Trial Unit (CTU) Network are placing greater emphasis on the implementation of patient and public involvement (PPI) in academic clinical research. In pursuit of this strategic goal, the SCTO sent out a survey to relevant stakeholders in order to identify and characterise all PPI initiatives and projects in Switzerland and thereby establish the status quo. As a next step, the SCTO envisions establishing a central coordination and contact point that is pathology-independent and spans organisations. We aim for a sustainable, inclusive PPI approach in academic clinical research that is established in close collaboration with our partners and stakeholders.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 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":"120815768","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.6.25
Therese Stutz Steiger, O. Menzel
Patients and members of the public contribute valuable information and perspectives to research projects because they have experienced a disease themselves or are close to someone affected by an illness. Patients with rare diseases are incredibly motivated to participate in research projects. Any advancement of scientific or medical knowledge or favourable political decisions can increase the possibility of a cure – or at least a treatment – that can stop or slow the progression of their disease and improve their quality of life. Patients’ lived experience may help researchers fill gaps in understanding conditions that they know mainly from theory. In this article, the authors address the need for more focus on patient-oriented clinical and public health research, the importance of bringing patients’ perspectives into research, issues around patient involvement, and areas for future research on the topic.
{"title":"Promoting inclusive, patient-oriented research: A rare disease patient perspective","authors":"Therese Stutz Steiger, O. Menzel","doi":"10.54920/scto.2021.rawatch.6.25","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.25","url":null,"abstract":"Patients and members of the public contribute valuable information and perspectives to research projects because they have experienced a disease themselves or are close to someone affected by an illness. Patients with rare diseases are incredibly motivated to participate in research projects. Any advancement of scientific or medical knowledge or favourable political decisions can increase the possibility of a cure – or at least a treatment – that can stop or slow the progression of their disease and improve their quality of life. Patients’ lived experience may help researchers fill gaps in understanding conditions that they know mainly from theory. In this article, the authors address the need for more focus on patient-oriented clinical and public health research, the importance of bringing patients’ perspectives into research, issues around patient involvement, and areas for future research on the topic.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"18 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":"132117935","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.6.8
D. Haerry, N. Brooke, M. Dutarte, J. Geissler
Patient and public involvement (PPI) in academic human research has been evolving in the United States and Europe since the early 1980s, when it was jump-started by activists responding to the HIV pandemic. This article provides a brief look at the development of PPI in academic human research in the US and Europe, highlights the PPI initiatives of several US and European organisations, discusses how PPI is gaining momentum in health technology assessment bodies, and provides recommendations for various stakeholders on how to incorporate more PPI into academic human research.
{"title":"The evolving practice of patient and public involvement in Europe and the United States","authors":"D. Haerry, N. Brooke, M. Dutarte, J. Geissler","doi":"10.54920/scto.2021.rawatch.6.8","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.8","url":null,"abstract":"Patient and public involvement (PPI) in academic human research has been evolving in the United States and Europe since the early 1980s, when it was jump-started by activists responding to the HIV pandemic. This article provides a brief look at the development of PPI in academic human research in the US and Europe, highlights the PPI initiatives of several US and European organisations, discusses how PPI is gaining momentum in health technology assessment bodies, and provides recommendations for various stakeholders on how to incorporate more PPI into academic human research.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"57 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":"126689478","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.6.22
R. Mucklow, C. Schmid
The European Patients’ Academy on Therapeutic Innovation (EUPATI) is an independent, non-profit foundation committed to changing the face of patient engagement through education. It provides training for patients and patient representatives on medicines research and development (R&D). EUPATI Switzerland (EUPATI CH) is the official Swiss EUPATI National Platform and acts as a central point for inquiries and cooperation for patient empowerment and involvement in medicines R&D in Switzerland. After successfully launching the increasingly popular annual Swiss Patient Forum (SPF) in 2017, EUPATI CH is currently developing a Swiss training module for Swiss patients and patient representatives who wish to be involved in patient engagement activities and who are interested in learning about the Swiss legal and ethical framework for clinical R&D in one of Switzerland’s national languages.
{"title":"Power to the patient: How EUPATI (CH) is changing the face of patient education","authors":"R. Mucklow, C. Schmid","doi":"10.54920/scto.2021.rawatch.6.22","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.22","url":null,"abstract":"The European Patients’ Academy on Therapeutic Innovation (EUPATI) is an independent, non-profit foundation committed to changing the face of patient engagement through education. It provides training for patients and patient representatives on medicines research and development (R&D). EUPATI Switzerland (EUPATI CH) is the official Swiss EUPATI National Platform and acts as a central point for inquiries and cooperation for patient empowerment and involvement in medicines R&D in Switzerland. After successfully launching the increasingly popular annual Swiss Patient Forum (SPF) in 2017, EUPATI CH is currently developing a Swiss training module for Swiss patients and patient representatives who wish to be involved in patient engagement activities and who are interested in learning about the Swiss legal and ethical framework for clinical R&D in one of Switzerland’s national languages.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"16 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":"114776552","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.6.19
Gabriela Zenhäusern, Lukas Jaggi
The COVID-19 pandemic has highlighted the value of public engagement as a way of building confidence in innovative treatments, diagnostics, and vaccines for coronavirus-induced disease that have been brought to market readiness within a very short space of time. Developing public trust and engagement extends beyond providing transparent research results and evidence-based information to creating a framework for a dialogue that includes patients’ perspectives. Whereas frameworks exist in the US, the UK, the Netherlands, and Germany, systematic patient involvement in Switzerland’s healthcare system is still taking root. Even though Swiss policymakers acknowledge the importance of stakeholder involvement in healthcare, tangible, overarching forms and systems of participation are only gradually being rolled out. Swissmedic, the Swiss Agency for Therapeutic Products, is also tackling the issue of how to integrate patients and the public into its regulatory processes. As it responds to this issue, Swissmedic aims to not only adopt current approaches but also actively create solutions that give patients a voice and incorporate their experiences and concerns into regulatory processes wherever possible.
2019冠状病毒病大流行凸显了公众参与的价值，公众参与是建立信心的一种方式，可以在很短的时间内将针对冠状病毒引起的疾病的创新治疗方法、诊断方法和疫苗推向市场。发展公众信任和参与不仅要提供透明的研究结果和基于证据的信息，还要建立一个包括患者观点的对话框架。尽管美国、英国、荷兰和德国都有相关框架，但瑞士医疗保健系统中系统性的患者参与仍在生根发芽。尽管瑞士政策制定者承认利益相关者参与医疗保健的重要性，但具体的、总体的参与形式和体系只是逐步推出。瑞士药品管理局(Swiss Agency for Therapeutic Products)也在解决如何将患者和公众纳入其监管流程的问题。在应对这一问题时，Swissmedic的目标不仅是采用当前的方法，而且还积极创造解决方案，让患者发出自己的声音，并尽可能将他们的经验和关切纳入监管过程。
{"title":"Involving patients and consumers in Swissmedic’s regulatory processes: From information sharing to participation","authors":"Gabriela Zenhäusern, Lukas Jaggi","doi":"10.54920/scto.2021.rawatch.6.19","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.6.19","url":null,"abstract":"The COVID-19 pandemic has highlighted the value of public engagement as a way of building confidence in innovative treatments, diagnostics, and vaccines for coronavirus-induced disease that have been brought to market readiness within a very short space of time. Developing public trust and engagement extends beyond providing transparent research results and evidence-based information to creating a framework for a dialogue that includes patients’ perspectives. Whereas frameworks exist in the US, the UK, the Netherlands, and Germany, systematic patient involvement in Switzerland’s healthcare system is still taking root. Even though Swiss policymakers acknowledge the importance of stakeholder involvement in healthcare, tangible, overarching forms and systems of participation are only gradually being rolled out. Swissmedic, the Swiss Agency for Therapeutic Products, is also tackling the issue of how to integrate patients and the public into its regulatory processes. As it responds to this issue, Swissmedic aims to not only adopt current approaches but also actively create solutions that give patients a voice and incorporate their experiences and concerns into regulatory processes wherever possible.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"5 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":"133211377","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.5.4
S. Méance
This article summarises the findings of an internal survey, which was conducted at the end of the first wave of the COVID-19 pandemic by the Swiss Clinical Trial Organisation’s (SCTO’s) Regulatory Affairs Platform (RA Platform). The survey showed that the Clinical Trial Units (CTUs) and Swiss Group for Clinical Cancer Research (SAKK) centres received many requests to support academic human research on COVID-19 during the first wave of the pandemic. Local strategies to prioritise research projects had to be adopted, new practices were implemented, and ways of working from home were successfully developed. The established RA Platform network was considered helpful for sharing information and effective practices. Synergies among research projects were initially missing, and better coordination should be encouraged. At the same time, services provided by and interactions with Swissmedic, swissethics, and the cantonal ethics committees (ECs) were much appreciated. Swissmedic and ECs focused their resources on projects related to COVID-19 and adapted their procedures to allow studies to start quickly. Some practices have been effective and should continue. The pandemic has shown that Switzerland can be considered a competitive place to launch studies in an emergency situation.
{"title":"First lessons learnt about the regulatory aspects of human research related to COVID-19: Perspectives from the SCTO's Regulatory Affairs Platform","authors":"S. Méance","doi":"10.54920/scto.2021.rawatch.5.4","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.4","url":null,"abstract":"This article summarises the findings of an internal survey, which was conducted at the end of the first wave of the COVID-19 pandemic by the Swiss Clinical Trial Organisation’s (SCTO’s) Regulatory Affairs Platform (RA Platform). The survey showed that the Clinical Trial Units (CTUs) and Swiss Group for Clinical Cancer Research (SAKK) centres received many requests to support academic human research on COVID-19 during the first wave of the pandemic. Local strategies to prioritise research projects had to be adopted, new practices were implemented, and ways of working from home were successfully developed. The established RA Platform network was considered helpful for sharing information and effective practices. Synergies among research projects were initially missing, and better coordination should be encouraged. At the same time, services provided by and interactions with Swissmedic, swissethics, and the cantonal ethics committees (ECs) were much appreciated. Swissmedic and ECs focused their resources on projects related to COVID-19 and adapted their procedures to allow studies to start quickly. Some practices have been effective and should continue. The pandemic has shown that Switzerland can be considered a competitive place to launch studies in an emergency situation.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"30 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":"125741612","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.5.22
Loane Warpelin-Decrausaz, A. Fayet-Mello
The World Health Organization’s Solidarity trial is one of the largest international randomised clinical trials for COVID-19 treatments in the world and provides an excellent example of a global effort to fight the pandemic. When Switzerland was invited to participate in the trial, the Swiss research community gave a resoundingly positive response. Researchers, investigators, hospitals, ethics committees, and authorities all worked together and made extraordinary efforts – in the midst of the difficulties brought on by the pandemic – to get the trial up and running in Switzerland in a relatively short amount of time. Lausanne University Hospital (CHUV) and the Clinical Trial Unit (CTU) Lausanne coordinate these remarkable efforts. In this article, two national coordinators for the Solidarity trial provide an overview of the trial, address some of the challenges encountered and solutions found when preparing for and conducting the trial in Switzerland, and discuss some of the lessons learnt so far that can be carried into the future.
{"title":"Swiss participation in the WHO’s Solidarity trial to test the efficacy of repurposed drugs for treating COVID-19: What the research community has learnt so far","authors":"Loane Warpelin-Decrausaz, A. Fayet-Mello","doi":"10.54920/scto.2021.rawatch.5.22","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.22","url":null,"abstract":"The World Health Organization’s Solidarity trial is one of the largest international randomised clinical trials for COVID-19 treatments in the world and provides an excellent example of a global effort to fight the pandemic. When Switzerland was invited to participate in the trial, the Swiss research community gave a resoundingly positive response. Researchers, investigators, hospitals, ethics committees, and authorities all worked together and made extraordinary efforts – in the midst of the difficulties brought on by the pandemic – to get the trial up and running in Switzerland in a relatively short amount of time. Lausanne University Hospital (CHUV) and the Clinical Trial Unit (CTU) Lausanne coordinate these remarkable efforts. In this article, two national coordinators for the Solidarity trial provide an overview of the trial, address some of the challenges encountered and solutions found when preparing for and conducting the trial in Switzerland, and discuss some of the lessons learnt so far that can be carried into the future.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 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":"134285540","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.5.31
Sonia Carboni
Can we speed up coronavirus vaccine development? A human challenge study, in which volunteers would be deliberately infected with coronavirus, could help in theory. In this article, two collaborators from the CTU Geneva explore the potential benefits and the risks associated with SARS-CoV-2 challenge studies.
{"title":"Human challenge studies in the time of COVID-19: Pros and cons","authors":"Sonia Carboni","doi":"10.54920/scto.2021.rawatch.5.31","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.31","url":null,"abstract":"Can we speed up coronavirus vaccine development? A human challenge study, in which volunteers would be deliberately infected with coronavirus, could help in theory. In this article, two collaborators from the CTU Geneva explore the potential benefits and the risks associated with SARS-CoV-2 challenge studies.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"59 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":"114375319","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.5.28
C. Schmid, A. Magnin
Uncoordinated and fragmented research activities were the scientific community’s early reactions to the COVID-19 pandemic, with researchers planning and running many small stand‐alone trials or observational studies of single‐agent uses. In this article, we discuss actions that were taken by the European Clinical Research Infrastructure Network (ECRIN) and its national partner the Swiss Clinical Trial Organisation (SCTO) to address the issue of uncoordinated clinical research.
{"title":"ECRIN’s and the SCTO’s roles as COVID-19 fosters innovation and catalyses cooperation amongst European clinical research actors","authors":"C. Schmid, A. Magnin","doi":"10.54920/scto.2021.rawatch.5.28","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.28","url":null,"abstract":"Uncoordinated and fragmented research activities were the scientific community’s early reactions to the COVID-19 pandemic, with researchers planning and running many small stand‐alone trials or observational studies of single‐agent uses. In this article, we discuss actions that were taken by the European Clinical Research Infrastructure Network (ECRIN) and its national partner the Swiss Clinical Trial Organisation (SCTO) to address the issue of uncoordinated clinical research.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"88 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":"132073468","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.5.15
Simone Ferbitz-Scheurer, Alexander Mion
The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.
{"title":"Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation","authors":"Simone Ferbitz-Scheurer, Alexander Mion","doi":"10.54920/scto.2021.rawatch.5.15","DOIUrl":"https://doi.org/10.54920/scto.2021.rawatch.5.15","url":null,"abstract":"The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"56 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":"124170862","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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