The decision making process by patients of whether or not to participate in clinicaltrials occurs in relation to the balance of profits obtained from clinical trials and thedisadvantage (especially, health damage) experienced in clinical trials, and the informationabout a critical adverse event is an important factor in the decision making process.
Among all report cases (1, 907 cases) provided to our hospital, 1, 014 cases (53%) were known adverse reactions and 844 cases (44%) were newly detected, The invesigators (physicians) judged the causal relationship between the investigationaldrug and adverse events observed, as follows ; “definite” 228 cases (12%), “probable” 555 cases (29%), “unlikely” 118 cases (6%), and “unknown” 907 cases (48%).Because about one half of all events make up “unknown” events, the burden andresponsibility of the medical institutions which undertake clinical trials to evaluate theclinical importance of reported events are very large.
Many of the events are observed in the drugs which are available commercially inforeign countries at present, and the burden of information management is great for theinstitutions. Another new problem is the difference in the interpretation of informationgiven in English, such as CIOMS report style and Med Watch report style, which maycause some confusion.
It is possible to enhance the accuracy of judging a causal relationship by standardizationof the information item and establishing the collection system . The transmission ofinformation using electronic media can increase the efficiency of data management inboth the medical institutions and the clinical trials subjects.

View full abstract

The aim of this study was to look at the clinical trials from the viewpoint of medicalinstitution's own data management. From source documents verification (SDV) from 33clinical trials (126 cases) carried out in Nippon Medical School Hospital between June1999 and July 2000, the verification rate, inconsistency rate and occurrence state ofdeviation were surveyed.
In the SDV of 126 cases, the mean verification rate was 97.5 ± 4.0% [mean± SD (range: 85.8-100%)]. The data with the lowest verification rate was on items for“evaluation” (82.9%) followed by “others”, “side effects/adverse events” and “withdrawal/dropout”. The major reason for the impossibility to verify was due to the factthat investigators entered the records directly to CRF without recording on to medicalcharts (no statement was made to regard data entered to CRF as source data). Otherreasons were due to the monitor's inappropriate interpretation of the medical chart, insufficient preparation of source documents for SDV. There was no case which sourcedata was missed.
Among the 26, 628 data verified, inconsistency was found between CRF and thesource documents in 333 data [1.7±2.3% (range: 0-8.1%)]. Inconsistency was causedmainly by inaccurate entering of data to CRF and by incomplete data of CRF due toomission of entry. Other reasons were miscalculation, misspelling, and contradictionbetween source documents.
In 126 cases 68 deviations were found. The majority was that laboratory tests hadnot been carried out. Serious deviations observed were those of exclusion/inclusioncriteria, inappropriate informed consent, and omission of the evaluation.
Data error observed in this survey were considered to be within the acceptable range.We conclude that by reviewing the verification rate, the inconsistency rate and theoccurrence state of deviation as measurements of quality of clinical trial data, eachmedical institution can achieve their own data management.

View full abstract

Since the 2000 academic year, we have conducted one week of pharmaceutical caretraining for the 5th and 6th year students of the faculty of medicine as part of the bedsideteaching (BST) program at the Department of Pharmacy, University of Tokyo Hospital.From the practical point of view, the textbook and curriculum of BST has been designedfor the medical students to understand the importance of the rational use of the drugs.In this study, handed out a questionnaire survey of the students' views on this BSTcurriculum. The medical students evaluated both the textbook and curriculum ; thepercentage of respondants answering “excellent” or “good” was over 80 percent. Theywere particularly interested in the dispensing section, and highly evaluated the programof “how to make out a prescription”. Furthermore, the students' impression of thehospital pharmacists was improved and they understood that the hospital pharmacistsplay an important role in the rational drug use and risk management of the medicalservice. The results showed that almost all medical students found this BST curriculumto be useful for the future when they would become doctors.

View full abstract