RWE in Japan: data governance arrangements
The Office of Health Economics (OHE; London, UK) has released a new consulting report evaluating the processes by which real-world data (RWD) are accessed, generated and used to produce real-world evidence (RWE) in Japan.
Real world-data (RWD) and real-world evidence (RWE) are playing an increasingly key role in clinical studies and healthcare decision making; medical societies are incorporating the use of RWE into their guideline revisions to create more useful medical decision tools. This latest Office of Health Economics (OHE; London, UK) report evaluates RWD governance arrangements in Japan. It follows the release of two previous such reports – in 2015 and 2017 – on the specifics under which RWE is used in eight countries (Australia, France, Germany, Italy, Sweden, the Netherlands, the UK and the USA), and South Korea respectively.
In the report, the current status of RWD use in Japan is described according to four categories: (1) core legislation and governance arrangement, (2) data linking, (3) data access, and (4) data use. These are considered against the ‘ideal RWD use framework’ outlined in the 2015 OHE report.
Frequently asked questions:
The report highlights that, in Japan, patients’ medical information may only be used for business purposes if patients' written consent for this has been provided; this includes data use by pharmaceutical and consulting companies. However, use of this patient data in academic studies is not restricted by such consent provision.
This means that the extent of RWD/E research studies undertaken by the private sector – including pharmaceutical and consulting companies – may be being restricted if these studies are not subcontracted to academic institutions.
However, this is not a case limited to Japan; in many counties the governance of data for research purposes differs between non-profit and for-profit organizations.
Further, the report highlights Japan’s strict de-identification laws; patients’ personal information may not leave the institution – hospital, insurer etc. – at which it was collated. These laws may limit the usability and interoperability of the data.
2018 Japanese legislation – the Next-generation Healthcare Infrastructure Act – may allow for certain, certified operators to collect patients’ personal information directly from healthcare providers and link this, at the individual level, to provide researchers with de-identified RWD. This has the potential to revolutionize RWD/E studies and use in Japan; however, as the law is so new, it is still uncertain to what degree data accessibility concerns will be addressed by it and what limitations these may therefore continue to impose.
Yasunaga H, Yamana H, Rodes Sanchez M, Towse A. Data governance arrangements for real-world evidence in Japan. (2019).
RWD is derived from various sources associated with outcomes in a heterogeneous patient population in real-world settings. These include patient surveys, claims registries and observational cohort studies.
RWD is observational data obtained outside the context of randomized controlled trials and generated during routine clinical practice. RWD depicts patient experiences in their real-world environments, outside of the tightly controlled, unnatural clinical trial settings.
Following a previous project in which the results of 30 randomized controlled trials were replicated, there is an ongoing initiative to employ RWE to predict the results of seven Phase IV trials. Termed 'RCT DUPLICATE', this study uses the Aetion Evidence Platform™ (NY, USA) and represents the first time researchers will attempt to predict the results of trials that have not concluded.