薬理と治療

Abstract

The importance of transparency in clinical trials is increasingly becoming recognized in Japan. We have committed to promote transparency such as making clinical trial information publicly available including the investigative sites’ name and address. 　　　The objective of this survey is to share the situation of clinical trial information disclosure. We collected the reasons why we could not obtain agreement from investigative sites to disclose their name and address and examined solutions. 　　　We started publishing investigative sites’ name and address on Pfizer Japan’s website from Oct 2017. We interviewed investigators, study coordinators, and other medical staffs involved in our clinical trials conducted between Oct 2017 to Dec 2019 and summarized their experience. 　　　The survey indicated about 1/3 of the sites did not agree to disclose their name and address on Pfizer Japan’s website. The main reasons not to disclose were discrepancies with sites’ policies, concerns that it would increase sites’ workload, and short enrollment period. It was also found that access to a website of one company was insufficient to enhance patient access. 　　　Combined efforts among patients, pharmaceutical industry, regulatory authorities, and health care providers are key in enhancing patient access to clinical trials.