European survey on national harmonization in clinical research

Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials through-out the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardizedpublishersversionpublishe

The Role of EUPATI CH in Promoting Patient Involvement in Clinical Research: A Multi-Stakeholder Research Project

Background: The European Patients' Academy on Therapeutic Innovation Switzerland (EUPATI CH) was established as an association in 2016 with the mission to improve patient empowerment in Switzerland, raise public awareness of EUPATI's education material, and foster multi-stakeholder partnerships in order to promote public involvement in all aspects of medicines research and development (R&amp;amp;D). In order to achieve its goal of improving patient involvement (PI) in all processes of medicines R&amp;amp;D in Switzerland and to obtain guidance and recommendations for future activities, EUPATI CH initiated a multi-stakeholder survey on PI experiences, hurdles, and best practices. The survey enabled EUPATI CH to obtain and analyze the views of various stakeholders and shape its workplan.Methods: Data collection occurred between January and July 2019 using a survey and semi-structured interviews with individual stakeholders from different groups. The online survey responses were analyzed using quantitative methods and the interviews were analyzed using qualitative methods.Results: The online survey was completed by 55 respondents (10%), and the semi-structured interviews were conducted with 14 stakeholders. Respondents to the online survey were patient representatives (45%), researchers from academia (25%), individuals from the pharmaceutical industry (9%), healthcare professionals (23%), and representatives from government agencies (6%). Some respondents were also members of EUPATI CH. Thirty-eight percent of respondents consider PI in Switzerland to be limited or absent. They identified the main barriers to PI as, first and foremost, a lack of funds and human resources (65%), followed by a lack of information and a lack of education on how to become a patient advocate (21%), a lack of collaboration with other stakeholders (16%), and a lack of adequate resources. Respondents' expectations of EUPATI CH's role in supporting PI were to provide education for active PI and improve networking and collaboration among stakeholders.Conclusions: EUPATI CH's multi-stakeholder research identified some of the difficulties in promoting PI in medicines R&amp;amp;D in Switzerland, in particular the complex collaboration among stakeholders and a lack of funds, human resources, and knowledge. To respond to these difficulties, EUPATI CH has begun preparing a basic training course for patients that is adapted to Switzerland.</jats:p

Erneuerte Vorlagen für Biobanken-Reglement, Information und Einwilligung: Ausarbeitung von schweizweiten Vorlagen für Biobanken-Reglement, Information und Einwilligung

Die Schweizerische Akademie der Medizinischen Wissenschaften (SAMW) hat 2006 die medizin-ethischen Richtlinien «Biobanken» veröffentlicht. Gestützt auf die Richtlinien hat eine gemeinsame Arbeitsgruppe der Stiftung biobank-suisse (BBS) und der SAMW, 2010 Vorlagen für einen Generalkonsent (Information und Einwilligung) und für ein Biobanken-Reglement ausgearbeitet und veröffentlicht [Salathé]. Die Vorlagen stellten den ersten schweizweiten Konsens betreffend Inhalt und Umfang der Patienteneinwilligung für die Weiterverwendung von Daten und humanen Proben für Forschungszwecke dar. Seit 2014 definiert das Humanforschungsgesetz (HFG) auch die rechtlichen Rahmenbedingungen für die Forschung mit menschlichen biologischen Materialien. 2013 beauftragte Swissethics, die Dachorganisation der Schweizer Ethikkommissionen für Forschung, eine Arbeitsgruppe unter Leitung von Prof. A. Perren mit der Ausarbeitung von Vorlagen zur Information und Einwilligung, welche Forschenden den Umgang mit dem HFG erleichtern sollte. Die von der Arbeitsgruppe «Biobanken» erarbeiteten Vorlagen für die Information und Einwilligung zur Weiterverwendung von Material und Daten für Forschungszwecke und das Biobankenreglement werden nachfolgend vorgestellt. Die Vorlagen sind in deutscher, englischer, französischer und italienischer Fassung auf der Webseite von Swissethics (www.swissethics.ch) veröffentlicht; sie werden regelmässig aktualisiert

Data_Sheet_1_The Role of EUPATI CH in Promoting Patient Involvement in Clinical Research: A Multi-Stakeholder Research Project.pdf

Background: The European Patients' Academy on Therapeutic Innovation Switzerland (EUPATI CH) was established as an association in 2016 with the mission to improve patient empowerment in Switzerland, raise public awareness of EUPATI's education material, and foster multi-stakeholder partnerships in order to promote public involvement in all aspects of medicines research and development (R&D). In order to achieve its goal of improving patient involvement (PI) in all processes of medicines R&D in Switzerland and to obtain guidance and recommendations for future activities, EUPATI CH initiated a multi-stakeholder survey on PI experiences, hurdles, and best practices. The survey enabled EUPATI CH to obtain and analyze the views of various stakeholders and shape its workplan.Methods: Data collection occurred between January and July 2019 using a survey and semi-structured interviews with individual stakeholders from different groups. The online survey responses were analyzed using quantitative methods and the interviews were analyzed using qualitative methods.Results: The online survey was completed by 55 respondents (10%), and the semi-structured interviews were conducted with 14 stakeholders. Respondents to the online survey were patient representatives (45%), researchers from academia (25%), individuals from the pharmaceutical industry (9%), healthcare professionals (23%), and representatives from government agencies (6%). Some respondents were also members of EUPATI CH. Thirty-eight percent of respondents consider PI in Switzerland to be limited or absent. They identified the main barriers to PI as, first and foremost, a lack of funds and human resources (65%), followed by a lack of information and a lack of education on how to become a patient advocate (21%), a lack of collaboration with other stakeholders (16%), and a lack of adequate resources. Respondents' expectations of EUPATI CH's role in supporting PI were to provide education for active PI and improve networking and collaboration among stakeholders.Conclusions: EUPATI CH's multi-stakeholder research identified some of the difficulties in promoting PI in medicines R&D in Switzerland, in particular the complex collaboration among stakeholders and a lack of funds, human resources, and knowledge. To respond to these difficulties, EUPATI CH has begun preparing a basic training course for patients that is adapted to Switzerland.</p

Improving sex and gender equity in research protocols: the new SAGER-swissethics recommendations

No abstract availabl

Seroprevalence trends of anti-SARS-CoV-2 antibodies and associated risk factors: a population-based study

Abstract Purpose We aimed to assess the seroprevalence trends of SARS-CoV-2 antibodies in several Swiss cantons between May 2020 and September 2021 and investigate risk factors for seropositivity and their changes over time. Methods We conducted repeated population-based serological studies in different Swiss regions using a common methodology. We defined three study periods: May–October 2020 (period 1, prior to vaccination), November 2020–mid-May 2021 (period 2, first months of the vaccination campaign), and mid-May–September 2021 (period 3, a large share of the population vaccinated). We measured anti-spike IgG. Participants provided information on sociodemographic and socioeconomic characteristics, health status, and adherence to preventive measures. We estimated seroprevalence with a Bayesian logistic regression model and the association between risk factors and seropositivity with Poisson models. Results We included 13,291 participants aged 20 and older from 11 Swiss cantons. Seroprevalence was 3.7% (95% CI 2.1–4.9) in period 1, 16.2% (95% CI 14.4–17.5) in period 2, and 72.0% (95% CI 70.3–73.8) in period 3, with regional variations. In period 1, younger age (20–64) was the only factor associated with higher seropositivity. In period 3, being aged ≥ 65 years, with a high income, retired, overweight or obese or with other comorbidities, was associated with higher seropositivity. These associations disappeared after adjusting for vaccination status. Seropositivity was lower in participants with lower adherence to preventive measures, due to a lower vaccination uptake. Conclusions Seroprevalence sharply increased over time, also thanks to vaccination, with some regional variations. After the vaccination campaign, no differences between subgroups were observed. </jats:sec

Changes in socioeconomic resources and mental health after the second COVID-19 wave (2020–2021): a longitudinal study in Switzerland

Abstract Background During the 2020/2021 winter, the labour market was under the impact of the COVID-19 pandemic. Changes in socioeconomic resources during this period could have influenced individual mental health. This association may have been mitigated or exacerbated by subjective risk perceptions, such as perceived risk of getting infected with SARS-CoV-2 or perception of the national economic situation. Therefore, we aimed to determine if changes in financial resources and employment situation during and after the second COVID-19 wave were prospectively associated with depression, anxiety and stress, and whether perceptions of the national economic situation and of the risk of getting infected modified this association. Methods One thousand seven hundred fifty nine participants from a nation-wide population-based eCohort in Switzerland were followed between November 2020 and September 2021. Financial resources and employment status were assessed twice (Nov2020–Mar2021, May–Jul 2021). Mental health was assessed after the second measurement of financial resources and employment status, using the Depression, Anxiety and Stress Scale (DASS-21). We modelled DASS-21 scores with linear regression, adjusting for demographics, health status, social relationships and changes in workload, and tested interactions with subjective risk perceptions. Results We observed scores above thresholds for normal levels for 16% (95%CI = 15–18) of participants for depression, 8% (95%CI = 7–10) for anxiety, and 10% (95%CI = 9–12) for stress. Compared to continuously comfortable or sufficient financial resources, continuously precarious or insufficient resources were associated with worse scores for all outcomes. Increased financial resources were associated with higher anxiety. In the working-age group, shifting from full to part-time employment was associated with higher stress and anxiety. Perceiving the Swiss economic situation as worrisome was associated with higher anxiety in participants who lost financial resources or had continuously precarious or insufficient resources. Conclusion This study confirms the association of economic stressors and mental health during the COVID-19 pandemic and highlights the exacerbating role of subjective risk perception on this association. </jats:sec

Global Climate

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