Total Quality System Breakdowns in Outsourced Clinical Trials.

摘要

Numerous deaths, tragedies, and underreported drug side effects occur in outsourced clinical trials. Total quality system breakdowns occur even though quality agreement contracts and quality management systems are used by pharmaceutical organizations. The purpose of this single case study was to explore strategies clinical quality assurance managers use to avoid breakdowns in quality with outsourced clinical trials in Asia-Pacific countries. The study included a purposeful sample of 15 clinical quality assurance managers from 1 pharmaceutical organization located in the Northeast region of the United States. The conceptual framework was von Bertalanffy's general systems theory. Face-to-face semistructured interviews or e-mail questionnaires containing open-ended questions were used to gather data from clinical quality assurance managers who had a minimum of 5 years of experience with outsourced clinical trials. Coded data and themes were identified through the modified van Kaam method. The three emergent themes were the following: vendor quality management, building quality in outsourced clinical trials, and quality management systems. Results of the study may contribute to social change by helping pharmaceutical organizations' leaders develop strategies and tools to improve the quality of outsourced clinical trials.