Patient-oriented clinical research has improved thanks to significant public investments in several initiatives, data infrastructures, and support instruments. These efforts have however also led to a fragmentation of activities and deficits remain. Published by the SAMS in 2021, the «White Paper Clinical Research» formulates seven goals to bring together the actors around a shared vision to increase the impact of clinical research and its benefits for all.
Elaborated by experts from various backgrounds, the White Paper Clinical Research analyzes the major driving forces that are transforming clinical research and identifies the weaknesses and redundancies of its current state in our country. Based on the notion that good care comes with – and from – good science, the white paper calls for a transformation of the clinical research culture so as to make it more integrative at all levels.
The key points
The white paper presents the necessity of strengthening the clinical research culture in hospitals and related research institutions. This will contribute to the development of a «learning healthcare system». Stronger involvement from patients and citizens and a direct engagement between scientists and the public is needed to promote education and an effective knowledge transfer.
To reach this goal, the education, training, mentoring, and support of clinical researchers with diverse profiles and at all career levels, is of paramount importance. In addition, interdisciplinary and interprofessional teams, involving patients and citizens, and integrating various perspectives must be fostered.
Clinical research methods should be expanded to include innovative clinical trial designs, precision medicine, health data research, and digital and technological approaches. Data-related guidelines need to be harmonized.
Considering the main stakeholders of the research landscape, fragmentation, overlaps, decentralized structures, regulatory hurdles, and a lack of shared strategic priorities are evident. A national alignment and coordination of efforts is essential to improve the quality and impact of clinical research.
In a roadmap, the white paper outlines the following seven goals which constitute an action plan for change to make Switzerland an international leader in patient-centered clinical research:
- Create a national platform to coordinate publicly funded stakeholders in clinical research
- Establish strong partnerships with society, citizens, and patients
- Promote a healthcare system that systematically integrates clinical research: good care comes with – and from – good science
- Invest in the development of innovative and dynamic clinical research approaches, designs, and technologies enabled by digital tools
- Strengthen translational, multidisciplinary, and integrated clinical research teams
- Ensure an environment that is attractive to clinical and health researchers and support them at all career levels
- Increase the efficiency and accelerate the delivery of clinical research by reducing the complexity of regulatory and data-related processes
National coordination platform for clinical research
Based on the white paper analysis, the State Secretariat for Education, Research and Innovation (SERI) has recognized the importance of strengthening the interaction between the public actors of clinical research, integrating the perspective of public health. It has mandated the SAMS, as an independent institution, to set up and operate a national coordination platform for clinical research for the ERI period 2021–2024. Such a broad exchange structure, bringing the actors of the entire clinical research spectrum to the same table, thereby allowing the alignment of efforts and clear distribution of tasks and responsibilities, has been missing so far.
The platform will not be a supervisory authority nor a regulatory body. Its mission is to help define concerted priority action areas for publicly funded clinical research and to formulate recommendations to the attention of decision-making bodies or of the SERI. Composed in its build-up phase of a small number of members so as to ensure an efficient functioning, its structure, organization and the necessary resources will be reexamined in view of the ERI period 2025–2028, so as to best serve the needs of all clinical research stakeholders.
It is planned to set up the platform and to start its activities by the end of 2021. The FAQ gives further information on its aims and positioning. The SAMS will contact the involved institutions directly and will communicate about the next steps through its usual channels – website, newsletter and bulletin.
Related activities and topics
The reflection on clinical research in Switzerland, long considered a «problem» in international comparison and compared to basic and experimental research, is one of the SAMS strategic priorities. Over the years, the SAMS has contributed to and elaborated several publications with the aim of improving the framework conditions for clinical research and has initiated, with its partners, many projects to strengthen the clinical research culture in academic medicine, to foster interdisciplinarity, to support early career researchers and to improve research infrastructures.
The White Paper Clinical Research (see above) presents a consolidated vision for the future of clinical research. Elaborated on behalf of the SERI, the white paper recommendations are expected to contribute to the Confederation's «Masterplan Biomedicine 2021–2025», which is currently being drafted. A Swiss-focused view to address the heterogeneity of the clinical research landscape was thus deliberately chosen. A detailed international benchmarking was considered outside the scope of the mandate.