Clinical Trial Ethics Committee
When a favorable safety and efficacy profile of a new drug can be reasonably expected in humans as a result of various studies using animal models of disease such as rats and mice, clinical trials in humans can be conducted.
Human clinical trials are conducted in three stages. The first stage is generally conducted in healthy adults and is used to determine how fast the drug is absorbed into the body and how it is excreted out of the body and how long this process takes. Initial evaluations of the safety profile are also made. In the second stage, the drug is administered to a relatively small group of patients to evaluate the efficacy and safety profiles of the drug, as well as to determine the most effective dosage and dosing interval. In the third stage, the drug is administered to a larger number of patients to confirm the efficacy and safety seen in the previous smaller studies.
When conducting clinical trials, Shionogi is required to observe the Ethical Principles for Medical Research Involving Human Subjects (World Medical Association “Declaration of Helsinki”), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, in addition to pharmaceutical regulations and laws of each participating country, and conduct the trial scientifically and medically with adequate ethical considerations. To ensure this, Shionogi has established an internal Clinical Trial Ethics Committee. This ethics committee consists of academic/social science specialists, including medical/healthcare professionals and legal professionals, along with members representing general public. All trials conducted by Shionogi are subjected to rigorous scientific and ethical review by this committee, and only those approved can be conducted.