<b>4．New Paradigm for Post-marketing Surveillance in Japan Which is Introduced New Pharmaco-epidemiology Research Design and Integrated Data Center Based Disease Registry </b> / 薬剤疫学

Using foreign clinical trial data in new drug submission, new drug can be approved with a few observations of Japanese patients. In current Japanese drug development situation, the importance of post-marketing surveillance (PMS) for Japanese patients has been increased. Rigid PMS system in Japan which has no selective options should be rescinded. In order to perform primary role of PMS which is to keep in safety and efficacy of pharmaceutical and medical devices, the Japanese PMS should change from standard form to selection of study design according to scientific consideration. The paper proposed that new pharmaco-epidemiology research design was applied to PMS and PMS were conducted by independent and integrated data center based disease registry.

<b>Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE</b> / 薬剤疫学

A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.<br>1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities<br>2．How to select Safety Specification (SS) and describe its characteristics<br>・Selection of SS<br>・Characterization of SS<br>・Association with Research Questions (RQ)<br>3．How to define and describe RQ<br>・What is RQ ?<br>・RQ interpretation in other relevant guidelines<br>・Methodology to develop RQ for PVP with examples<br>・Best approach to integrating PVP for whole aspects of safety concern<br>4．How to optimize PVP for specific RQ<br>・Routine PVP or additional PVP ?<br>・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)<br>・Checklist to help develop PVP<br>5．Epilogue:<br>・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.<br>・Significance of background incidence rate and needs for comparator group<br>・Infrastructure for the future PVP activities<br>6．Appendix: Checklist to help develop PVP activities in RMP<br>The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

<b>Revisiting Sampling Methods in Cohort Studies and Case-Control Studies</b> / 薬剤疫学

In pharmacoepidemiology, cohort studies and case-control studies have been commonly used as research methods to examine causal relationship between exposures to medicines and occurrences of advance events. For both study designs, we could assume a common population at risk, in which cases are developed. A cohort study defines a research cohort within the population at risk and tries to investigate the research cohort directly, and a case-control study tries to investigate the research cohort partly by the control sampling. Assuming an underling research cohort, it becomes possible to understand cohort studies and case-control studies within an unified framework. We revisited several sampling methods to select controls in case-control studies and effect measures implied by the sampling methods. (Jpn J Pharmacoepidemiol 2013; 18(2): 95-111)

<b>Case-Crossover Study</b> / 薬剤疫学

Case-crossover study is research using only data from cases, patient with interested event. Getting control from own data, the case-crossover study is classified into self-controlled study. It has a lot of condition to be valid study. When study satisfies the conditions, the case-crossover has a lot of advantage in which it is not necessary to collect information of control group patients, and the control is to be matched genetic and other background. The paper is summarized the case-crossover study design. (Jpn J Pharmacoepidemiol 2013; 18(2): 90-94)

<b>Case Cohort Study</b> / 薬剤疫学

In this article, we provide a brief summary of a case-cohort study design and an introduction of Japan Statin Study (JSS) as an example for case-cohort study conducted in Japan. In the case-cohort study, the control as a sub-cohort is randomly selected from a research cohort at the beginning of the study. As it is not necessary to be sampled a control by interesting event in the research, the study design as well as cohort study can examine some events in the same time. Therefore the study design can be also applied to pharmaco-vigilance survey. The case-cohort study design has wide application range. (Jpn J Pharmacoepidemiol 2013; 18(2): 84-89)

<b>Case-Control Study within a Cohort</b> / 薬剤疫学

In this article, we provide a brief summary of study design of case-control study within a cohort and an introduction of two case-control studies within a cohort conducted in Japan recently using antihypertensive drug database based on the post-marketing surveillance data of pharmaceutical companies. In the case-control study within a cohort, it is possible to avoid bias caused in a case-control study and conduct more efficiently than cohort study. Therefore the case-control study within a cohort widely has been used in pharmacoepidemiological studies with a database. (Jpn J Pharmacoepidemiol 2013; 18(2): 77-83)

<b>The Use of SS-MIX in Clinical Trials and Postmarketing Studies： From the View of Pharmaceutical Industries </b> / 薬剤疫学

Those of us in the pharmaceutical industry are in favor of using SS-MIX standardized storage to alleviate the burden on medical professionals. As previously suggested, in addition to the benefits of reducing study periods, supporting a variety of investigative research and safety measures, and obtaining more accurate data on disease states and treatments, actively using this kind of new technology is a societal imperative in an information-driven society. Possible practical uses include (1) general application in drug use surveillance and special drug use surveillance, (2) appropriate sampling surveys, (3) patient monitoring, (4) observational studies with controls, such as those using disease registries, and (5) reviewing the results of safety measures. However, there is the issue of regulatory interpretation and consensus, with debate on information protection, and the issue of social infrastructure. Therefore, industry, government, and academia must continue its active, cooperative discussion to enable true implementation of this technology. (Jpn J Clin Pharmacoepidemiol 2013; 18(1): 57-64)