JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial To conduct a clinical trial, an applicant (a phar- maceutical or medical device marketer) must prepare a protocol and receive approval for such protocol from an institutional review board (IRB). A protocol must cover, among other things, the subject material, purpose, design, methods, statistical considerations and organisation of the proposed clinical trials. The applicant is also required to register the protocol with the MHLW through the PMDA. In practice, the applicant consults with the PMDA informally about its draft protocol before formally registering the protocol with the MHLW. 2.3 Public Availability of the Conduct of a Clinical Trial The website of the National Institute of Pub- lic Health discloses certain basic information regarding clinical trials conducted in Japan, including: • the title of the study; • the subject material of the study; • a brief summary of the study; • information about the monetary sponsor, the relevant IRB, and other organisations involved; • contact information for the parties involved; and • a summary of the results. 2.4 Restriction on Using Online Tools to Support Clinical Trials There is no apparent prohibition on using online tools to support clinical trials, which are gen- erally required to be conducted by doctors or hospitals and include in-person interviews with, and written informed consents from, clinical trial subjects. Recruiting clinical trial subjects can be conducted online. In addition, under a guideline
from the MHLW, if an approved protocol for a clinical trial provides for online medical checks in the clinical trial, such medical checks can be conducted on an online virtual examination basis. 2.5 Use of Data Resulting From Clinical Trials Raw data obtained from clinical trials is consid- ered to be sensitive data of clinical trial subjects. Therefore, clinical trial data obtained by a doctor or hospitals (investigators) is usually converted into a form that prevents the identities of clinical trial subjects from being discoverable and only such anonymised information or data is provided to the sponsor of the clinical trial. Furthermore, upon commencement of a clinical trial, investi- gators must obtain an informed consent letter from each trial subject regarding the use and treatment of such subject’s sensitive personal data as well as potential risks associated with the trial subject’s participation. 2.6 Databases Containing Personal or Sensitive Data As mentioned in 2.5 Use of Data Resulting From Clinical Trials , it is common practice for result- ing data to be anonymised, and in such form the data is not regulated as strictly as sensitive data. Disclosure of original, non-anonymised data (raw data) is heavily regulated as sensitive infor- mation under the Act on the Protection of Per- sonal Information (APPI). In applying the APPI regulations, data of clinical trial results that “can identify specific individuals through easy match - ing with other information” (easy matching) is generally considered to be non-anonymised and sensitive personal data. The Federation of Pharmaceutical Manufacturers’ Associations of Japan issues the Guidelines for the Proper Handling of Personal Information by Pharma- ceutical Companies. Such Guidelines note that
189 CHAMBERS.COM
Powered by FlippingBook