Advocating for a balanced and fit-for-purpose regulatory environment for clinical research in Switzerland, the SCTO is engaged in numerous activities. In 2023, we analysed and evaluated the potential impact of the proposed revisions to the ordinances of the Human Research Act (HRA) and provided our feedback during the public consultation process. At our annual roundtable, we continued the dialogue with Swissmedic and swissethics about good clinical practice (GCP) inspections.
On 24 July 2023, the SCTO submitted its consolidated feedback on the partial revision of the ordinances associated with the Human Research Act (HRA) to the Federal Office of Public Health (FOPH).
Overall, the FOPH’s efforts to adapt to advances in digitalisation and innovative developments are welcome. The additional possibility of e-consent is appreciated and is considered a big step forward in the endeavour to foster digitalisation.
However, several changes raise serious concerns in terms of usability and practicability. There is considerable concern that the proposed changes cannot be transferred into real-life research without an additional administrative burden to researchers and their organisations (i.e. hospitals).
We look forward to continuing our dialogue with the FOPH in 2024.
Since 2014, the SCTO has organised an annual roundtable discussion between experts from Swissmedic, swissethics, and the SCTO CTU Network in order to discuss challenges and share news from each of the institutions. This discussion serves to promote mutual understanding and cooperation when it comes to resolving operational difficulties in the area of clinical research.
This year’s roundtable focused on the revised Informed Consent Form Template from swissethics as well as the results of Swissmedic’s Good Clinical Practice (GCP) inspections and the Electronic Submission Portal IMP/ATMPs from Swissmedic.
The SCTO Safety Platform and swissethics revised together the Annual Safety Report form for investigator-initiated trials (IITs) governed by the Clinical Trials Ordinance (ClinO) and/or the Ordinance on Clinical Trials with Medical Devices (ClinO-MD).