The Discussion of Volunteer Management Methods in PhaseⅠ Clinical Trials for New Drugs

Objective To analyze the main factors affecting volunteer management in phase I clinical trials and explore the Methods of enhancing the volunteer compliance and the quality of clinical trials. Methods In terms of the volunteer recruitment, informed consent, screening, the control of the trial procedure and the follow-up, we compared the volunteer management before the measures in 2008-2011 and after the measures in 2012. Results The rate of recruited subjects increased and the recruitment period was shortened one fold by the combined recruitment methods. A fully informed consent, strict screening and volunteer training in the trials improved the compliance of the subjects. The professional follow-up was useful for our work. Conclusion Taking effective measures in volunteer management improved the compliance of the subjects, which enhanced the quality of clinical trials.