Test Subjects' Perception of Clinical Trials of Drugs and Pharmacist Clinical Research Coordinators' Responsibilities: A Questionnaire Survey
10.2185/jjrm.56.22
- Author:
Katsuko OKAZAWA
;
Mitsuo TAKANO
- Publication Type:Journal Article
- MeSH:
Clinical;
Questionnaires;
Clinical Trials;
Clinical Research;
Testing
- From:Journal of the Japanese Association of Rural Medicine
2007;56(1):22-28
- CountryJapan
- Language:Japanese
-
Abstract:
A questionnaire survey was taken on the subjects administered an investigational new drug in order to look into their attitude toward a clinical testing and assessment of the work of the pharmacists clinical research coordinating the testing. Questionnaires were sent to 75 outpatients who were tested on with a new drug between January 2001 and March 2006. 55 individuals responded to the inquiry. All the subjects were taken care of by the coordinators by turns. The major concerns to the testees when they participated in the trial were the adverse reactions and efficacy of the new drug. Of the subjects who felt uneasy, 79.4% cited the adverse reactions and 50% about the efficacy. Some 80% of the respondents said they were satisfied with the explanation given beforehand about the nature of the clinical testing. The majority of the subjects, when they were in a fix, turned to pharmacist clinical reave coordinators for advice, not the physician nor nurses. The guidance given by the clinical reave coordinators about medication was generally received favorably. From the above-mentioned findings, it was made clear that the pharmacists clinical research coordinating the clinical trial played an important role as consultants in alleviating the anxiety of the testees during the trial. In the future, pharmacists will do the best to measure up to the expectations as coordinators in the clinical trial of new drugs by improving care of the testees individually while taking into their backgrounds and wishes into full consideration.