Overvolunteering in Phase I Trials

The need for a system to prevent overvolunteering has been recognised for many years.   

TOPS ( T he O vervolunteering P revention S ystem) was developed to prevent healthy volunteers from participating too frequently in clinical studies of potential new medicines. https://www.tops.org.uk/info.htm . Twenty one phase I units and CROs are now using the TOPS system to detect overvolunteering . The system requires only national insurance number or passport number to identify the subject, and the date the subject was last dosed.

In a newsletter from COREC dated 12 April 2005 , the following points were made regarding the TOPS system:

“Type 1 RECs may be interested in this website, as there are scientific, safety, and ethical reasons why healthy volunteers should not participate too frequently in studies of potential new medicines. First, the subject might be exposed to interacting substances in consecutive studies. Second, the results of a study might be influenced by the subject’s participation in a previous study. Third, an excessive volume of blood might be removed from the subject. Fourth, it is unethical for subjects to be exposed too frequently to pharmaceutical products from which they can derive no benefit.”