Objective : To get first-hand information on and understand MEDWatch, a newly created program of the US FDA, on safety information reporting and management.
Design and Method : Through a visit to the FDA office by Japanese members of the ICH M1 (Medical Terminology) Expert Working Group (EWG) and other concerned experts, and discussion with relevant FDA staffs.
Results and Conclusion : (1) The MEDWatch program was introduced in June 1993, to accelerate the spontaneous reporting of adverse events (AE) to FDA by developing a single Adverse Event Reporting Form, i.e., FDA 3500, for (1) drugs, (2) biologics (except vaccine), (3) medical devices, (4) food, and (5) veterinary medicines; (2) Five responsible sectors in FDA have been working together to develop a smooth flow of information from health care professionals and industries; (3) The remarkable result from the development of this new program is the increased reporting of serious AE; (4) Much efforts have been exerted by FDA on the education of health professionals through various health societies and through publications; (5) Some of the issues which remain unresolved include database integration of NDA and PMS information; (6) Advocacy of the AE concept and importance of reporting thereof by health care professionals and the use of simple, easy-to-fill-out form is recommended in Japan.

This is a report of the 16th Annual Conference on Student Selection held on August 30, 1997 in Tokyo. The main topic of discussion was the subject whether bachelor's degree must be required to medical school applicants. Advantages, disadvantages and expected future problems concerning the proposal by the advisory committee of the Ministry of Education and Culture are widely discussed.

This is a report of the activities of the committee on medical student selection 1994-1996, particularly focused on the 15th Conference on Medical-Student Admission held 1996/8/31 with the subjects of social needs and influences upon high school education for the purpose of improving student selection system in Japan. We must consider how largely admission tests have being influenced high school students at the time of decision making, what medical schools they submit their applications to, and what ability the society or community requires physicians, for creating better system of evaluation for admission in Japan.

Continuous subcutaneous injections of medication are effective in controlling symptoms of the terminal stage of cancer. Chlorpromazine and levomepromazine occasionally cause skin irritation. We examined all patients who underwent continuous subcutaneous administration of psychotropic drugs (chlorpromazine, levomepromazine, midazolam) at the palliative care unit of our hospital from April 2010 to March 2013, the frequency of adverse skin reactions of Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 3 or above. Of the 603 hospitalized patients, 389 (64.5%) underwent continuous subcutaneous administration of one of the three drugs. The frequency of grade 3 or above (ulceration or necrosis) adverse skin reactions was 4 out of 345 chlorpromazine cases (1.2%; 95% CI: 0.0-2.3%), 2 out of 90 levomepromazine cases (2.2%; 95% CI: −0.8-5.2%), and 0 out of 210 midazolam cases (0.0%; 95% CI: 0.0-0.0%). The frequency of serious adverse skin reactions caused by continuous subcutaneous administration of psychotropic drugs was low, suggesting that this treatment is relatively safe for the skin.

We used questionnaires to study the present status of undergraduate clinical training at medical schools in Japan in February 1996. Completed questionnaires were returned by 81%(65) of 80 medical schools and approximately 54%(1, 328 clinical departments) of the schools. The results were as follows. Courses for early clinical exposure in the 1st or 2nd year were provided at 83% of the 65 schools; clinical clerkships in the 5th and 6th years were provided at 28%. Specific behavioral objectives for clinical training were clearly shown to students and teaching staff at 75% of schools. Clinical procedures that medical students were permitted to perform were listed and announced to students and teaching staffs at 66% of schools. Patients were informed and gave consent for clinical training of students at 77% of schools. Essential knowledge and skills of students were assessed before the start of clinical training at 40% of schools, and summative assessment was made at the end of the training at 72%. Training of clinical teaching staff for faculty development was conducted at 51% of schools. Eightynine percent of schools reported a shortage of clinical teaching staff. Similar results were obtained in the survey of clinical departments of university hospitals: most departments complained of a shortage of teaching staff, of students not being active, and of students not being competent to enter clinical training courses. To improve clinical training, the introduction of clinical clerkships and cooperation with community facilities outside universities were the main issues.

A questionnaire survey on clinical procedures performed by medical students on patients during undergraduate clinical training was conducted in february 1996. Responses were received from 1328 clinical departments of university cospitals at 80 medical schools. Basic clinical procedures that medical students were permitted to perform on patients were recommended by a committee of the Ministry of Health and Welfare. These procedures are divided into three categories: level 1; procedures that medical students are permitted to perform under the supervision of an instructor; level 2; procedures medical students are permitted to perform with supervision under certain conditions; and level 3; procedures for which medical students are generally limited to assisting instructors or to attending and observing patients. The status of performance of the procedures was investigated. Of level-1 procedures (36 procedures), 8 were performed by medical students at more than 80 % of university hospitals, 19 were performed at from 50% to 70%, 9 were performed at less than 50%. Of level-2 procedures (15 procedures), 8 were performed at from 55% to 79% of hospitals and 7 were performed at less than 50%. For level-3 procedures (15 procedures), medical students were permitted to assist and observe 4 procedures at from 82% to 86% of hospitals, 11 at from 50% to 79%, and 1 at40%. In addition, students were permitted to perform 13 level-3 procedures at from 10% to 44% of hospitals and to perform 3 at from 6% to 9%. In many clinical departments, other kinds of procedures specific to the departments were adopted. Teaching media, such as standardized patients' computer-assisted instruction models, and animal materials, were used, and facilities in the community cooperated in training. Respondents wrote many suggestions and opinions about the difficulties and concerns with the legality of students' performing clinical procedures, patients' consent or agreement, minimal essentials of clinical competence of students, the shortage of instructors, and the training and guidelines for instructors.

We surveyed in every medical university in Japan on how attitudes development is adopted in its medical educational curriculum so far. There are several universities which in some way have already adopted attitudes development into curriculum or teaching items. However, hours of lesson and the contents are so differed among them. Moreover, both evaluation of these lessons by trainees and judgement as far the educational effect by trainers are not programmed satisfactorily. Some universities complain of manpower shortage, difficulties of fixing curriculum, or shortage of total lesson hours, so that they say they cannot dare work on this attempt. But, there are still an increasing number of universities ready to start their programs, where education arranged by non-medical teachers, practical medical experience at the real front, the introduction of simulated patient (SP) into education, and so on are considerd to be carried out.
Thus, we suppose it is time to have and share some guideline for adequate attitudes development education at this moment. And at the same time, a national system to encourage the medical education, including trainning SP, is urgently required to be planned.

Objective: The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. Methods: Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30–30.6 Gy in 15–17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50–50.4 Gy in 25–28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. Results: Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9–52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%–88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. Conclusion The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.