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Involving patients in academic clinical research: It’s time to walk the talk 让患者参与学术临床研究:是时候言出必行了
Regulatory Affairs Watch Pub Date : 2021-10-01 DOI: 10.54920/scto.2021.rawatch.6.36
Cordula Landgraf
{"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}
引用次数: 2
Promoting inclusive, patient-oriented research: A rare disease patient perspective 促进包容性，以患者为导向的研究:罕见病患者的观点
Regulatory Affairs Watch Pub Date : 2021-10-01 DOI: 10.54920/scto.2021.rawatch.6.25
Therese Stutz Steiger, O. Menzel
{"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}
引用次数: 0
The evolving practice of patient and public involvement in Europe and the United States 在欧洲和美国，病人和公众参与的不断发展的实践
Regulatory Affairs Watch Pub Date : 2021-10-01 DOI: 10.54920/scto.2021.rawatch.6.8
D. Haerry, N. Brooke, M. Dutarte, J. Geissler
{"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}
引用次数: 0
Power to the patient: How EUPATI (CH) is changing the face of patient education 病人的力量:EUPATI (CH)如何改变病人教育的面貌
Regulatory Affairs Watch Pub Date : 2021-10-01 DOI: 10.54920/scto.2021.rawatch.6.22
R. Mucklow, C. Schmid
{"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}
引用次数: 0
Involving patients and consumers in Swissmedic’s regulatory processes: From information sharing to participation 让患者和消费者参与瑞士医疗监管流程:从信息共享到参与
Regulatory Affairs Watch Pub Date : 2021-10-01 DOI: 10.54920/scto.2021.rawatch.6.19
Gabriela Zenhäusern, Lukas Jaggi
{"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}
引用次数: 0
First lessons learnt about the regulatory aspects of human research related to COVID-19: Perspectives from the SCTO's Regulatory Affairs Platform 从与COVID-19相关的人体研究的监管方面吸取的第一个教训:从SCTO监管事务平台的角度来看
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.4
S. Méance
{"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}
引用次数: 0
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 瑞士参与世卫组织“团结”试验，以测试重新使用药物治疗COVID-19的疗效:迄今为止研究界的收获
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.22
Loane Warpelin-Decrausaz, A. Fayet-Mello
{"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}
引用次数: 0
Human challenge studies in the time of COVID-19: Pros and cons COVID-19时期的人类挑战研究:利弊
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.31
Sonia Carboni
{"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}
引用次数: 0
ECRIN’s and the SCTO’s roles as COVID-19 fosters innovation and catalyses cooperation amongst European clinical research actors ECRIN和SCTO在COVID-19方面的作用促进了欧洲临床研究参与者之间的创新和合作
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.28
C. Schmid, A. Magnin
{"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}
引用次数: 0
Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation 从COVID-19危机中吸取的教训:与人体研究和产品授权相关的监管方面
Regulatory Affairs Watch Pub Date : 2021-03-01 DOI: 10.54920/scto.2021.rawatch.5.15
Simone Ferbitz-Scheurer, Alexander Mion
{"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}
引用次数: 0
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