ACCP Position Statement: "Sentinel Dosing--Time for a Risk-based Approach?"

, /PRNewswire/ -- The American College of Clinical Pharmacology^® (ACCP) published a recent Position Paper entitled "Sentinel Dosing—Time for a Risk-Based Approach?" Human testing of experimental drugs is historically a remarkably safe exercise that leads to the approval of therapeutics that significantly improve quality of daily life and survival. Yet quite rare safety events during this testing period have led to a cumbersome and expensive general approach to assessment of drugs in early stages of clinical trials. Within this general approach is sentinel dosing, a process in which 1-2 subjects receive the drug before a slightly larger group of 4-6 subjects, receive the drug. The widespread use of sentinel dosing in early trials is typically found to be unnecessary but is still conducted as part of First-in-Human studies. In those rare cases where a serious drug-related event occurred, sentinel dosing would not have prevented the injury or death.

ACCP has published a Position Paper that argues for more limited use of sentinel dosing. If heeded, more efficient drug development will ensue and there will be less false optimism for experimental drugs that do have serious safety issues.

About ACCP
ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals.  

SOURCE American College of Clinical Pharmacology