The Swissmedic guidance released an information sheet titled "Combined Studies: Clinical Investigations of Medical Devices, Medicinal Products, and Advanced Therapy Medicinal Products (ATMPs)" which provides a detailed framework for sponsors, CROs, and investigators conducting combined clinical investigations involving medical devices and medicinal products in Switzerland. This guide, effective from October 31, 2024, is essential for understanding submission processes, modifications, reporting obligations, and safety measures specific to combined studies.
Combined Study: The term ‘combined study’ has not yet been formally defined in a Swiss or European regulation.
Combined studies can be understood as studies that involve: A clinical trial of an MP / ATMP in parallel with an interventional performance study of an IVD & A clinical trial of an MP / ATMP in parallel with a clinical investigation of an MD.
This guidance aims to guide stakeholders through the approval, conduct, and reporting requirements for combined studies, which are studies that involve both medicinal products (MPs) or advanced therapy medicinal products (ATMPs) alongside medical devices (MDs) or in vitro diagnostic (IVD) devices.
Combined study applications must be submitted simultaneously to Swissmedic and the responsible cantonal ethics committee. A complete submission package, including a power of attorney if needed, must be submitted through Swissmedic's eGov Service eMessage portal. Swissmedic reviews the MP/ATMP and MD/IVD aspects, collaborating with the ethics committee before issuing final approval. In cases with more than one sponsor, all sponsors must be listed in the application. Communication is primarily sent to the first listed sponsor.
Amendments can affect MP/ATMP, MD/IVD, or both aspects of the combined study. Substantial amendments require Swissmedic approval, while non-substantial modifications only require notification. For cases where modifications impact multiple combined studies or related clinical trials, Swissmedic allows a single submission or separate submissions.
Sponsors can submit a combined annual report covering both MP/ATMP and MD/IVD aspects or separate reports. Notifications regarding study completion, early termination, or suspension must specify if they pertain to MP/ATMP or MD/IVD aspects. For more details, please refer to the full document on the Swissmedic website or directly through the following link:
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