임상시험용 의약품 복약지도 항목에 대한 임상시험대상자 및 연구자의 요구도 조사

Abstract

Medication counseling in clinical trials is important for patient safety and implementation of the scientific method. During clinical trials, although basic information about the drug is provided through the participant instructions, there is a lack of research on the extent of the patient awareness of this information, demand for medication guidance by participants, and the appropriate medication guidance methods. A survey was conducted by us in September 2014, enrolling subjects self-administering drugs for a clinical trial, and a study on the principle investigator (PI) and clinical research coordinator (CRC) participating in the clinical trials. The survey related to preferences for medication counseling methods and demand for specific categories, as well as other additional items for clinical trial subjects, to evaluate their awareness of the drugs in the clinical trial. We analyzed the responses of 111 clinical trial subjects and 67 investigators (21 PI and 46 CRC). In terms of preferences for medication counseling methods,‘ written and oral guidance together’was high for both subjects and investigators. When inquired regarding categories for which medication counseling was required, subjects gave the most positive responses for‘ adverse effects’(96.3%) and‘ drug interactions’( 95.4%), while investigators responded highly for ‘methods of use’(100%) and ‘adverse effects’ (100%). The category‘ methods of use’especially showed a significant difference between investigators and subjects in terms of positive response rate, at 100% and 91.7%, respectively (p 0.0001). Categories in which the subjects’awareness of the drugs in the clinical trial was lacking included ‘difference with drugs on the market’(58.6%),‘ interactions with other drugs’(50.5%), and‘ whether the drug is available for sale’(45.1%). Meanwhile, the criteria high on the list of investigators included accurate clinical trials, including guidance about methods of use and dealing with missed doses. Based on the categories revealed by our survey, it will be possible to suggest constituent elements for medication counseling in the future, that accounts for the demands of both subjects and investigators regarding drugs in clinical trials.