Increasing Complexity of Clinical Trials

Increasing Complexity of Clinical Trials

Definitions:
Procedures: include lab & blood work, routine exams, x-rays & imaging, questionnaire & subjective assessments, invasive procedures, heart assessment, etc.

Protocol: the clinical-trial design plan
Enrollment rate: the percentage of volunteers meeting the increasing number of protocol eligibility criteria (percentage screened who were then enrolled)

Retention rates: the percentage of volunteers enrolled who then completed the study; declining retention rates mean that firms must enroll more patients initially and/or recruit more patients during the trial.

Increasing Complexity of Clinical Trials
During the last decade clinical trial designs and procedures have become much more complex, demanding more staff time and effort, and discouraging patient-enrollment and retention

Unique Procedures per Trial Protocol (Median)
Total Procedures per Trial Protocol (Median)
Clinical-Trial Staff Work Burden (Measured in Work-effort Units)
Length of Clinical Trial (Days)
Clinical-Trial-Participant Enrollment Rate
Clinical-Trial-Participant Retention Rate

Increasing Complexity of Clinical Trials.ppt