Our Approach to Clinical Trials

Chugai conducts clinical trials rigorously with high ethics and scientific properties, paying close attention to ensuring safety and respecting the human rights of clinical trial participants in accordance with global standards.

Clinical trials are essential processes in the development of pharmaceuticals to determine their safety and efficacy, and they are rigorously conducted with high ethical and scientific values, respecting the human rights of participants, and paying close attention to ensuring safety.

Chugai complies with relevant regulations such as the Pharmaceuticals and Medical Devices Act and internationally recognized standards for clinical trials such as the Declaration of Helsinki*1 and the ICH Guideline*2 in order to conduct clinical trials ethically for the purpose of market launch. Based on those laws, regulations, and global standards, Chugai prepares standard operating procedures, follows necessary and adequate procedures, and the value of the drug is reliably determined step by step with making maximum consideration inferring from the non-clinical results and drugs with similar mechanism of action as scientific aspects.

Clinical trial planning is designed by experts in fields such as medicine, pharmacy, statistics, and clinical pharmacology, and the protocol is assessed the ethics and scientific nature of the risks and safety impacts of participants by the internal and institutional review boards. Clinical trials are conducted in accordance with an approved protocol.

Following the initiation of clinical trials, safety information is collected and evaluated in a timely fashion, and if necessary, Chugai communicates information to participants, regulatory authorities, and study sites, always giving top priority to ensure the safety of participants. With regards to the quality of clinical trials, Chugai takes various measures to ensure the reliability of clinical trial results.

Chugai conducts clinical trials with ethics and safety to participants as the top priority. Chugai also respects and protects the human rights of participants (e.g., personal dignity, right to self-determination, privacy, and personal information protection) and obtains informed consent from all participants (or their legally acceptable representatives) appropriately. Clinical trial participants can communicate their opinions on clinical trials to Chugai via their physicians or clinical trial coordinators, and Chugai will respond seriously to their opinions.

To ensure clinical trials in a scientific and ethical manner, employees involved in conducting clinical trials are required to be trained in relevant laws, ICH guidelines, standard operating procedures, and scientific standards, and to meet other necessary requirements.

Chugai is also outsourcing some tasks related to clinical trials to contract research organization (CRO). Chugai regularly monitors CROs and outside contractors involved in conducting or managing clinical trials on behalf of Chugai to ensure and audit that they meet Chugai’s Quality Assurance Policy. Chugai will disclose any violations of laws and regulations or serious ethical violations or corrective actions as a result of regular monitoring.

Chugai believes that sharing clinical trial data in an appropriate manner is important for improving the transparency of clinical trials and ensuring social trust. For further details, please refer to “Clinical Trial Data Sharing.”

  • *1 The Declaration of Helsinki refers to Recommendations for Physicians Engaged in Biomedical Research Involving Humans adopted at the World Medical Association General Assembly in 1964. Biomedical research does not contribute to actual healthcare, unless it is ultimately based on testing in humans. Current clinical trials are based on the Declaration of Helsinki in 1964 as an ethical foundation (Source: The Pharmaceutical Society of Japan)
  • *2 ICH is an abbreviation of the International Conference on Harmonization of Drugs and Regulations in the U.S., EU, and Japan and stipulated as guidelines on the matters that should be adhered in terms of Quality, Efficacy, Safety, Multidisciplinary, etc.
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