The «White Paper Clinical Research» published by the SAMS in 2021 has shown the necessity to bring the actors of the entire clinical research spectrum to the same table, thereby allowing a better alignment of efforts and a clearer distribution of tasks and responsibilities. The State Secretariat for Education, Research and Innovation (SERI) has mandated the SAMS to set up and manage the national Coordination Platform Clinical Research (CPCR) for the ERI period 2021–2024.
What is the goal of the platform?
To strengthen the interaction between public stakeholders of clinical research at the national level; to exploit synergies; to reduce redundancies and to improve the coordination and the use of resources. The platform should support an institutionalized dialogue in the field of 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 is 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 is the platform anchored?
For its build-up phase, 2021–2024, the SAMS acts as an «honest broker» and is in charge of operating the platform. It assures its scientific secretariat, support its activities, and is in charge of liaison with the SERI.
What are the main tasks of the platform?
The platform will help to define the framework conditions to implement the measures proposed in the white paper and specify the tasks and responsibilities for this. It will also 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.).
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.
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. While 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) focuses on building up infrastructures, processes and a policy framework for the exchange of clinical data needed for research. Similarly, other national entities all have a specific focus and field of action (SAKK: clinical cancer research; SNSF: research funding; SBP: biobanks and biosamples; unimedsuisse: university hospitals and medical faculties; SSPH+: public health, etc.).
What is the initial composition of the platform?
While the experts involved in the elaboration of the white paper 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 in additional expertise. The initial composition of the platform, based on the SERI mandate, is described on the platform website.
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.