Public consultations

Evaluation of the Human Research Act

The SCTO contributed to the evaluation and revision of the Human Research Act (HRA) by participating in working groups and projects, including:

• a working group initiated by the Federal Office of Public Health (FOPH) comprised of representatives from groups of relevant stakeholders;
• a survey project on descriptive statistics in the HRA (using BASEC data), executed jointly by the SCTO’s CTU Network, Cochrane Switzerland, and the Basel Institute for Clinical Epidemiology and Biostatistics.

Complete revision of the Medical Devices Ordinance and the Ordinance on Clinical Trials with Medical Devices

Through its CTU Network and Regulatory Affairs Platform, the SCTO coordinated contributions to the public consultation of the total revision of the Medical Devices Ordinance (MedDO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD).

Furthermore, the SCTO network provides training for research teams on how to comply with these regulations.

Contributions to good lay summary practice

The EU Clinical Trial Regulation requires a lay summary of trial results to be disseminated in accessible language within 12 months after the end of the study and even earlier, within 6 months, for paediatric trials. In response to this, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Forum for Good Clinical Practice (EFGCP) put in motion the Roadmap Initiative to Good Lay Summary Practices. The SCTO and EUPATI CH, the Swiss national platform of the European Patients’ Academy on Therapeutic Innovation, both contributed to this initiative. 

In addition, the SCTO, its Regulatory Affairs Platform, and SwissPedNet contributed to the EU Commission’s public consultation on recommendations for good lay summary practice. Together with its partner organisation the Swiss Group for Clinical Cancer Research (SAKK), the SCTO submitted comments to the Good Lay Summary Practice document. 

Moreover, the SCTO and the SAKK developed a concept for two joint events in 2021: the SCTO Forum and the SAKK Symposium, both of which address good lay summary practice with the goals to raise awareness of the topic within Switzerland and provide information on how to best prepare for this new requirement.