Based on the analysis of the White Paper Clinical Research published by the SAMS in 2021, the State Secretariat for Education, Research and Innovation (SERI) has recognized the importance of strengthening the interaction between the public actors of clinical research, including the perspective of public health. It has mandated the SAMS, as independent institution, to set up and manage a national coordination platform for clinical research for the ERI period 2021–2024.
What is the goal of the platform?
To strengthen the coordination of public stakeholders of clinical research at a national level; reduce the number of instances in which the same topics are discussed in parallel and distribute tasks more efficiently by bringing key actors to the same table; define concerted, overarching national priorities for publicly funded clinical research.
Why is this platform needed?
Because in the current clinical research landscape in Switzerland, other national structures all have a specific focus and none are currently set up to serve as a national, single point of contact where institutional actors of the entire spectrum of clinical research, including public health, can coordinate the various aspects of clinical research.
Who gives the platform its legitimacy?
The SERI, as lead federal instance, has given a mandate to the SAMS to set up and operate the platform for the ERI period 2021–2024.
Where will the platform be anchored?
For the build-up phase, 2021–2024, the SAMS which has no conflict of interest and will act as «honest broker», will be in charge of setting up and operating the platform. It will assure its scientific secretariat, support its activities and be in charge of liaison with the SERI.
How will the platform be positioned towards other national clinical research institutions?
The platform should strengthen the interaction between all key actors of publicly funded clinical research. The Swiss Clinical Trial Organisation (SCTO) primarily focuses on the support, coordination, and methodological development of clinical trials, for which it is the leader organization at the national level. The Swiss Personalized Health Network (SPHN), as a national initiative active until 2024, focuses on building up infrastructures, processes and a policy framework for the exchange of clinical data needed for research. Other national entities all have a specific focus and field of action.
What will the main platform tasks be?
The platform will help to define the framework conditions to implement the measures proposed in the white paper and identify further fields of action to strengthen the coordination of public stakeholders and improve the use of resources. The platform will prepare recommendations for the attention of the responsible decision-making bodies, or of its mandating instance SERI, which will coordinate further actions with other federal organs (FOPH, swissmedic, SECO, etc.). The SERI might give subsequent mandates to the institutions of the ERI domain for the implementation of the measures.
What will the platform not do?
The platform will not be a regulatory body, it will not be a supervisory authority, and it will not primarily be a point of contact for external requests nor for international actors, at least not during the build-up phase. These tasks are assured by other institutions funded by the Confederation.
What will the initial composition of the platform be?
While the experts involved in the elaboration of the White Paper Clinical Research did so ad personam, the platform will bring together representatives from the main public institutions of clinical research active at the national level and from key stakeholder groups (patients and early career clinical researchers). In the build-up phase, the platform will be kept small so as to work efficiently. Its composition will be adapted over time depending on its tasks by bringing additional expertise. The initial composition of the platform is described in the SERI mandate (in German).
When will the platform be launched?
It is planned to set up the platform and to start its activities by the end of 2021. The SAMS will contact the involved institutions directly and will communicate about the next steps through its usual channels – website, newsletter and Bulletin.
What is the long-term vision for the platform?
The build-up phase (2021–2024) will serve to further define the fields in which a national coordination and concertation is needed, and to specify the platform's tasks and the required resources. After 2024, the structure, organization, and institutional anchoring of the platform beyond the build-up phase will be reexamined to best serve the needs of the clinical research stakeholders.