The Department of Clinical Research Support supports the planning of clinical research and offers provisional consultation, especially in investigator-initiated NDA trials. We coordinate consultations between academia and the regulatory Pharmaceuticals and Medical Devices Agency (PMDA) of the Ministry of Health, Labour and Welfare (MHLW) of Japan. Our members have extensive experienced in every phase of pharmaceutical affairs activities.
The Department of Clinical Epidemiology cooperates in providing consultation services and expert advice on clinical research design and statistics to NCNP investigators as they launch new research projects. This service includes free face-to-face clinical design and biostatistics consultation. Staff also participate in the review of study protocols by the NCNP Ethics Committee.
The ethical implications of research involving humans are paramount to consider. TMC staff advise on a number of inquiries about research ethics, such as how to handle human tissues from patients with rare disease, how research results will be reported (especially health-related information incidentally found through the research), and what the national policy is for human ES cell research. Our goals at TMC are to handle inquiries from any researcher on ethical issues regarding human subject research and to ensure our research is totally ethical and appropriate, from the viewpoint of not only the researchers, but also patients, research participants, and society in general. As part of these efforts, we also provide ethics education to researchers on, for example, the ethical principles of human subject research, research misconduct and authorship, ethical dilemmas in human genetic research involving minors, and national and international policy for protecting human subjects.