Report of the Study Group on Utilization of Big Data in the Medical and Health Fields vol.4
Masami Morita (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Kazuteru Sugiura (Senior Researcher, Pharmaceuticals and Industrial Policy Research Institute)
Takayuki Sasaki (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
(Published May 2019)
This study group has been conducting research and studies in order to make recommendations on important issues in the utilization of big data in the medical and health fields, with "utilization of PHR" as the main theme in FY 2018, and to discuss trends in infrastructure development and the expansion of utilization data based on two major trends: "data distribution platforms centered on individuals" and "expansion of utilization data. We conducted a survey and research on the trends in infrastructure development and the expectations and challenges of utilization in the pharmaceutical industry based on the two major trends of "data distribution platforms centered on individuals" and "expansion of utilized data.
PHR (Personal Health Record) is expected to cover a wide variety of personal data managed at the will of individuals and medical health information over a lifetime, so-called life course health data. As a backdrop, data portability is being discussed worldwide, and platforms that integrate and distribute a variety of data with the individual as the axis are emerging in various fields. These platforms, which are characterized by the ease of integrating and collecting diverse data and the ease of access to individuals, can be expected to be utilized in various ways in the pharmaceutical industry, from research and development to post-launch.
The pharmaceutical industry is also expanding the scope of data that can be utilized not only by medical institutions, but also by those outside of medical institutions. For example, in the research area, there are attempts to link personalized medicine and preventive/preemptive medicine through integrated analysis of health checkup data and vital data in addition to genomic and clinical data; in the clinical development area, data from wearable devices can be used as evaluation indicators; and post-launch, solutions can be provided to support early diagnosis and early detection of adverse events. In the area of clinical development, efforts are being made to use data from wearable devices and other devices as evaluation indices. In utilizing data, it is important to be aware of the "Fit for Purpose" perspective, and to use different platforms for different purposes based on their characteristics, such as the type of platform and the data subject. In addition, the utilization of PHRs will become an indispensable element in the pharmaceutical industry as well, in view of the progress of the paradigm shift in healthcare, such as personalized medicine, preventive and preemptive medicine, patient-centered medicine, and the shift from "things" to "services. We have made five proposals as important initiatives to promote the use of PHRs.