February 28, 2012
Today, it is very common for pharmaceutical companies to conduct global clinical trials in emerging and developing countries instead of just in ICH regions (i.e. the U.S., EU and Japan), in order to accelerate clinical development and regulatory approvals around the world. In conducting clinical trials anywhere in the world, we must prioritize human rights, safety and welfare of the participating patients.
Also in clinical trials conducted by Eisai, we consider compliance and ethical conduct, based upon on ICH guidance and regulatory guidelines of each country, as a top priority. According to our Code of Conduct, we must comply with GCP regulations as well as pharmaceutical laws, and conduct business activities that conform to high ethical standards that are based on ourhhcphilosophy.
Furthermore, we disclose information at appropriate times on clinical studies conducted by Eisai that meet certain criteria, and thus ensure transparency of our clinical studies and that patients and medical professionals are able to access such information. We have also established our very own clinical trial registration and result disclosure policy which takes into consideration the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” issued by the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations), and the regulatory requirements for clinical trial information disclosure in major countries. Our clinical trial information is disclosed via the U.S. National Institute of Health (NIH) website, ClinicalTrials.gov (https://clinicaltrials.gov/). We also disclose clinical trial information in compliance with the local regulatory requirements in each country as necessary.