The introduction and promotion of information technology (IT) in institutional review boards (IRB) have been a topic of intense discussions. From around 2012, practical examples using tablet devices and cloud systems have been reported. For sponsors and clinical trial offices, introduction of IT has been shown to result in benefits such as shortening of preparation time, reduction of paper waste, and cost reduction. In 2013, the Ministry of Health, Labour and Welfare specified the filename format for electromagnetic records and recommended PDF as the file format in the guidelines for the use of electromagnetic records. We introduced tablet devices and developed operational processes based on the guidelines. For the operation, IRB members pointed out that it was difficult to identify the document contents from the filenames, because there were numerous files and the PDF filenames were coded. To overcome this demerit from IRB members' viewpoint, we have developed four algorithms and an “Institutional Review Board Support System” that improve readability of PDF files and allow completion of operations in a short time. The system is able to merge PDF files in a preset order, convert the coded PDF filename into a format including the document name, and detect filenames not conforming to the guidelines. Using the system, a process that conventionally takes several up to ten hours can be completed in a few minutes. The system can also be applied to tablets devices and cloud systems. We believe the system is helpful in the promotion of IT in IRB.

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The Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs (the Committee) was launched in 2009 to address the issue of unapproved drugs or off-label uses of drugs that are approved in the other developed countries but not in Japan. The Committee evaluates whether a proposed drug or treatment meets high medical needs by reviewing the formal petitions submitted by patient advocacy groups, academic societies, and pharmaceutical companies. Based on the review of the Committee, the Ministry of Health, Labour and Welfare (MHLW) determines the mode of regulatory authorization process. Especially for unapproved use of an approved drug, the MHLW decides whether the use meets the criteria for “abbreviated application of publicly known but unapproved indication”. If applicable, the marketing authorization holder can submit a dossier for the abbreviated application, which includes existing data generated from clinical practice without additional clinical trial data. If the drug does not meet the criteria, new data from additional registered clinical trials are usually required. As of June 2014, the MHLW gave decisions on the mode of regulatory process for 174 petitions submitted to the Committee during the first and the second public recruitments for drug development. We reviewed these documents to determine which factors were associated with the decision of abbreviated application. Among 59 petitions received in the second recruitment providing detailed background and reasons necessitating the development, 21 petitions provided the data of domestic investigator-initiated prospective trials. Seventeen of the 21 petitions were determined to be valid for abbreviated application, indicating a strong association with the presence of domestic clinical trial data. On the other hand, regulatory approval in other developed countries, despite being a prerequisite for abbreviated application, was inversely associated with actual designation of the abbreviated application. The clinical data required for designation of the abbreviated application are not as well controlled as one derived from conventional clinical trial data, and consequently are expected to have a lower evidence level. The abbreviated application strategy should be cautiously employed while the issue of drug lag is being resolved gradually in Japan.

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The aim of the present trial was to compare the sedative effects of second generation antihistamines in healthy adult male volunteers. This randomized, double-blind, cross-over clinical trial compared the effects of single doses of olopatadine 5 mg, ketotifen fumarate 1.38 mg, fexofenadine 60 mg, and placebo on psychomotor function in 15 healthy male subjects who gave written informed consent for participation in the study. For each sedative, sleep latency time was measured using the multiple sleep latency test (MSLT); and psychomotor function was measured by thresholds of critical flicker fusion (CFF), the digit symbol substitution test (DSST), and a Straight line Analog Rating Scale (LARS). Measurements were performed before and 2, 5, and 8h after drug administration. The differences between the drugs and placebo were analyzed by repeated analysis of variance (ANOVA) and paired t-tests as appropriate. Intergroup differences in baseline values of all parameters were not significant. Ketotifen induced the shortest sleep latency at 2h (p＝0.03 vs. fexofenadine, p=0.03 vs. olopatadine) and 5h (p=0.04 vs. fexofenadine) after administration. Ketotifen also showed the most prolonged recognition (CFF down) at 2h (p<0.001 vs. fexofenadine, p=0.03 vs. olopatadine) and 8h (p=0.01 vs. fexofenadine). Olopatadine showed a more prolonged recognition than fexofenadine at 2h (p=0.03). Ketotifen induced the greatest decline in concentration and cognitive function at 8h (p=0.03) according to DSST. The drugs affected objective psychomotor function without causing subjective symptoms as shown by no significant differences in LARS score. The study indicates that the extent of impaired performance, an important adverse drug reaction, may differ even among second generation antihistamines.

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