As of April 2005, “Shihango-rinsyoushiken” defined in the GPMSP was renamed “Seizouhanbaigo-rinsyoushiken” in the revised regulations (GPSP). The relevant part of the GCP was also modified at the same time. Strictly speaking, therefore, post-approval clinical trials are not the same as postmarketing clinical trials. This report provides an explanation of post-approval clinical trials and the related regulations. It is generally considered that post-approval clinical trials, which help gather more clinical information, should be actively pursued for the further development of approved drugs in the post-marketing setting. However, the results of the questionnaire show that pharmaceutical companies are not willing to conduct them, mainly due to the high cost. To improve the economic efficiency of post-approval clinical trials, it is necessary to streamline monitoring activities that account for 40% of the cost.

BACKGROUND/AIMS: Upper gastrointestinal symptoms are more frequent and severe in female than in male outpatients in Japan. This study compared the upper gastrointestinal symptoms between healthy male and female young adult volunteers using a questionnaire. METHODS: In total, 581 third-grade medical students at Saga Medical School aged 22 to 30 years underwent upper gastrointestinal endoscopy and completed a questionnaire (frequency scale for symptoms of gastroesophageal reflux disease) from 2007 to 2013. Of these 581 students, 298 who were negative for Helicobacter pylori infection and had no particular lesions on endoscopic examination were enrolled in the present evaluation. A symptom was defined as positive when the subject evaluated the frequency of the symptom as sometimes, often, or always. RESULTS: The subjects comprised of 163 males (average age, 23.7 years) and 135 females (average age, 23.1 years). Upper gastrointestinal symptoms were more frequent in the females (75 of 135, 55.6%) than males (69 of 163, 42.3%; P < 0.05), with a high score for 4 symptoms (bloated stomach, heavy feeling in the stomach after meals, subconscious rubbing of the chest with the hand, and feeling of fullness while eating meals). Of the 144 subjects (69 males and 75 females) who complained of these symptoms, the females complained of dysmotility symptoms more often than did the males, but this was not true for reflux symptoms. CONCLUSIONS: This study suggests that females develop upper gastrointestinal symptoms more frequently than do males among the young healthy Japanese population.
Asian Continental Ancestry Group* ; Dyspepsia ; Eating ; Endoscopy ; Endoscopy, Gastrointestinal ; Esophagitis ; Female* ; Gastroesophageal Reflux ; Gastrointestinal Motility ; Hand ; Helicobacter pylori ; Humans ; Japan ; Male* ; Meals ; Outpatients ; Schools, Medical ; Stomach ; Students, Medical ; Thorax ; Unconscious (Psychology) ; Volunteers* ; Young Adult