Clinical Evaluation LLC
Avoiding errors in planning and conduct of clinical trials
Many clinical trials are adversely affected by preventable errors in the preparation or implementation of a study protocol. These waste resources and may delay study completion or impact the accuracy and reliability of the data collected. Institutional Review Board assessment may not “flag” all these errors.
Examples of questions that may be posed to reduce such problems include:
- Are the Protocol Inclusion/Exclusion (I/E) criteria medically reasonable and defensible and does the protocol adequately address all permitted and prohibited medications or classes of medication?
- How will the I/E requirements affect recruiting efficiency and the time course of the study? What is the research organization’s range of screen failure rates? Will failure rates be monitored during screening?
- Are the protocol-specified adverse events consistent with GCP/ICH guidelines? Conflict with GCP/ICH is more common than is usually assumed.
- What are the sponsor’s and the research organization’s definitions of “Clinically Significant” and “Not Clinically Significant” abnormalities of laboratory testing, electrocardiography, and physical examination? Are these definitions evidence-based?