Ensuring the Safety of Participants in Clinical Trials

Clinical trials carried out by Shionogi are conducted in compliance with the Helsinki Declaration, the ICHGCP and other guidelines, and Japan’s Pharmaceutical Affairs Law or other regulations applicable in the country where the trial is conducted. In the case of participation in a clinical trial, written informed consent is obtained based on the free will of the participants and the utmost efforts are made to protect the participants’ human rights, ensure their safety and improve their well-being.

Specifically, in all clinical trials that Shionogi carries out, the highest priority is shown for ethical concerns. To guarantee the appropriateness of the trial in scientific and medical terms, it is conducted in accordance with a trial protocol that has been reviewed and approved by independent review committees established within the Company and within the medical institution (ethics committee/institutional review board). Additionally, during the conduct of the clinical trial, a staff member of the medical institution is responsible for collecting safety information on the participants, and where safety information relating to newly observed serious adverse events in the participants is received, a prompt report is made to the participating medical institutions and the regulatory authority of the relevant country in accordance with GCP, the regulatory provisions of the country, and company regulations. In this way, the utmost efforts are made to ensure the safety of participants in the clinical trial.