青森県津軽地区の病院における治験実施体制の実情に関する調査津軽地区治験ネットワークの設立のために Investigation on Conducting Clinical Research Studies within Hospitals in the Tsugaru Area of Aomori Prefecture
The investigation of the ability to perform of clinical research study in a hospital was carried out in the Tsugaru area of Aomori Prefecture, as a first step toward the establishment of a regional network group for clinical research studies in this area. A questionnaire was thirteen questions on the following factors was distributed: 1) number of personnel in the hospital, 2) names of clinical departments in the hospital, 3) number of outpatients per day, 4) number of beds for inpatients, 5) number of protocols accepted for performing a clinical research study in one year, 6) management rules of the Investigational Review Board (IRB), 7) management rules of clinical research study office, 8) clinical research coordinator (CRC) protocol for clinical research trial, 9) control protocol for clinical research drugs, 10) monitoring system of clinical data by a pharmaceutical company, 11) support program for the patients in the clinical research study, 12) distribution method of the profit from a pharmaceutical company within the hospital, 13) evaluation of the clinical research study in the hospital. Nineteen questionnaires were sent to hospitals in the Tsugaru area. The return rate of the questionnaire was 47%, and five hospitals belonged to the Tsugaru Clinical Research Study Network Group, that is 26% of all questionnaires . All six hospitals within the Clinical Research Network Group, which included a university hospital, are general hospitals . About three thousand outpatients are treated in the hospitals of our clinical research network each day. The six hospitals within our regional network group have a total of 1985 beds for the treatment of inpatients. All six hospitals have had previous experience performing clinical research studies. However, there were differences between hospitals in the number of accepted protocols and the number of patients enrolled in clinical research trials . Two hospitals have set up a clinical research office, and the department of pharmacy or the hospital office functions as a clinical research office in two hospitals, and a clinical research coordinator (CRC) is available in three hospitals, which included the university hospital. With the exception of the university hospital, there is no monitoring room in the participating hospitals. Based on these results, the hospitals within our clinical research network appear to be fully capable of performing a clinical research study, however, a clinical research infrastructure needs to be established at several of the hospitals.
- 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 37(4), 235-238, 2006-07-31
The Japanese Society of Clinical Pharmacology and Therapeutics