Survey of Participants' Satisfaction with an Investigator-initiated Clinical Trial and Their Appraisal of Clinical Research Coordinators

Abstract

Background: While many previous studies have examined the satisfaction of participants in clinical trials sponsored by pharmaceutical companies for the development of new drugs, few studies of subject satisfaction have been conducted on investigator-initiated clinical trials. The present study surveyed the participants' satisfaction with an investigator-initiated clinical trial and their appraisal of clinical research coordinators (CRCs).
Methods: A questionnaire was sent by post to 32 middle-aged patients who participated in a phase II trial related to an orthopaedic disease. The questionnaire consisted of a total of 16 items. The participants were asked to fill out the questionnaires anonymously and return them by post.
Results: The response rate of the questionnaire was 91%. The contribution of CRCs to the trial was highly rated and they were considered indispensable to the clinical trial. Particularly, CRC's knowledge about the healthcare and insurance systems was given a high score, and their assistance at medical examinations during the trial was also highly rated.
Conclusion: The present study revealed the needs and potential contribution of CRCs in an investigator-initiated clinical trial for an orthopedic disease. Further studies are required to determine whether the results obtained from the present study can be generalized to clinical trials in other clinical areas.