Practical considerations in planning and conducting clinical trials with investigational or marketed drugs

A system is presented to increase efficiency in planning, initiating, conducting, and analyzing the results of a clinical trial. The procedures to be used are designed to assist clinical investigators of sponsored or unsponsored studies, as well as drug corporations and other sponsors of drug studies. The series of checklists and steps to follow may be easily modified for individual trials. The procedures and steps to be implemented are described in terms of the following nine categories: Interview and Selection of Investigator(s); Clinical Study Initiation: I. Internal Documents and Procedures; Clinical Study Initiation: II. Information for the Investigator to Send to the Sponsor; Clinical Study Initiation: III. Information for the Sponsor to Send to the Investigator; Prestudy Roundtable Meeting; Conducting the Clinical Study; Monitoring and Troubleshooting a Study; Clinical Study Termination; and Clinical Study Data Entry and Analysis.