Annual report on inspections of clinical trials as part of Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for designing, conducting, documenting and reporting clinical trials with human subjects. During the period from 2022 to 2024, Swissmedic conducted 114 inspections out of a total of 139 drug studies. The focus was on the protection of participants and data quality. Trials conducted by academic sponsors (universities, public research or healthcare institutions) faced more critical findings than those conducted by commercial sponsors (pharmaceutical companies).

Between 2022 and 2024, Swissmedic conducted GCP inspections of clinical trials with medicinal products. The most frequently identified deficiencies were as follows:

• Failure to ensure the safety of the subjects
• Incomplete or deficient source documentation (e.g. missing or incorrect data)
• Shortcomings in organisational structures and in the quality management system (e.g. missing or deficient written instructions and inadequate staff training)

Swissmedic has increased the number of GCP inspections in recent years. The inspections included routine inspections and so-called "for-cause" inspections, which are triggered when serious deficiencies are suspected. Most inspections were completed without any serious complaints. Academic sponsors were the subject of critical findings more frequently than commercial sponsors. Such observations help to rectify weak points and refine standards. The results underscore the crucial importance of quality management and active study monitoring by the sponsors.

Rectifying deficiencies

On completion of a GCP inspection, the sponsor must submit an action plan to rectify the identified deficiencies within four weeks. Swissmedic reviews this plan and approves it for implementation. If the therapeutic products agency identifies areas for improvement in the plan, the sponsor must submit a revised version.

Regulatory framework in Switzerland

In Switzerland, the legal basis for clinical trials is set out in the Therapeutic Products Act (TPA), the Human Research Act (HRA) and the Ordinance on Clinical Trials (ClinO). These laws are based on international guidelines such as ICH GCP and ensure that clinical trials are conducted in accordance with the highest ethical and scientific standards. Accordingly, GCP helps to ensure the protection, dignity and safety of the trial participants, as well as the integrity of the generated data. At the same time, GCP makes an important contribution to quality assurance in research.