The new article outlines the reporting requirements to be followed by the parties responsible for clinical investigations conducted in Switzerland.
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Swissmedic, the country’s regulatory agency in the sphere of healthcare products, has published an information sheet dedicated to combination studies. The document provides an overview of the applicable regulatory requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved.
At the same time, the authority reserves the right to make changes to the document and information provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Reporting Duties During Combined Studies
In combined studies, the reporting duties are outlined in the Clinical Trials Ordinance (ClinO) for medicinal products (MPs) / advanced therapy medicinal products (ATMPs) and in the ClinO-MD for medical devices (MDs) / in-vitro diagnostic devices (IVDs) apply. These duties include timelines and safety event definitions.
All submissions related to reporting, except those for SUSARs (Suspected Unexpected Serious Adverse Reactions), must be made through the eGov Service eMessage portal.
Annual Safety Report (ASR) / Development Safety Update Report (DSUR)
In accordance with the applicable legislation, sponsors can submit either a combined report that includes information on both the MP/ATMP and MD/IVD aspects of the study or separate reports for each aspect.
To submit ASR/DSUR reports:
- Use form BW610_20_025e_FO and indicate which aspect(s) of the study (MP, ATMP, MD/IVD, or multiple) the report pertains to.
- All reports should be placed in the folder 17.3.0_Annual_safety_report.
- If the report includes information about the MP/ATMP, also include the FO submission form and place it in folder 18.00.
Study Completion, Discontinuation, or Interruption
To notify Swissmedic about the regular completion, discontinuation, or interruption of a study for reasons unrelated to safety, the party responsible for a study should use the form BW610_20_025e_FO. Indicate which aspect of the study (MP, ATMP, MD/IVD, or multiple) is affected.
If the notification involves the MP/ATMP, include the FO submission form in folder 18.00.
- A final report must be submitted within one year of the study’s completion (or the completion of that aspect).
- If a temporary halt or early termination is related to the MD/IVD aspect, the final report is due within three months.
(Serious) Adverse Events
Sponsors must ensure that investigators and laboratory personnel apply the appropriate seriousness criteria from both the Clinical Trials Regulation (CTR) and the Medical Device Regulation (MDR)/In-Vitro Diagnostic Regulation (IVDR) for all adverse events (AEs). Both sets of regulations must be followed for reporting duties.
For companion diagnostics (CDx), determining the relationship between the IVD (or its test results) and an adverse event (AE or SAE) can be complex. Adverse events may occur during or long after the CDx test.
Swissmedic will accept events categorized as “not related” to the CDx unless there is evidence that the quality of testing might have affected the result. If such issues arise, the (S)AEs should be re-evaluated regarding their relationship to the IVD.
Problems could stem from factors like sample collection, preparation, storage, the IVD itself, its application, or test evaluation.
Safety Measures
The following safety measures must be submitted to Swissmedic using form BW610_20_026e_FO:
- Notification of discontinuation or interruption of a combined study (or aspect) for safety reasons.
- Notification of safety and protective measures.
- Notification of urgent safety measures (USM).
The form must specify which aspect(s) of the study (MP, ATMP, MD/IVD, or multiple) are concerned by the safety measure, and the eDok should be populated according to section 3 instructions.
For the submission of SUSARs, the CIOMS form must be completed, and the instructions in the information sheet BW101_20_002e_MB should be followed. It is crucial to use the Swissmedic reference number provided in the authorization letter for the combined study when submitting SUSARs.
For notifications related to ATMP events, form BW315_00_960e_FO should be completed, following the instructions in the information sheet BW315_00_961e_MB. Again, the Swissmedic reference number from the authorization letter must be used for all ATMP-related submissions.
Conclusion
In summary, reporting during combined studies requires strict adherence to the reporting obligations outlined in the ClinO and ClinO-MD. This includes submitting annual safety reports, adverse event reports, and notifications of study completion or interruptions. Safety measures and urgent actions must be promptly communicated to Swissmedic, with proper categorization of the study aspects involved. For both MPs/ATMPs and MDs/IVDs, sponsors must ensure that all reporting follows specific procedures, using appropriate forms and reference numbers for timely submission.
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