As it stands investigators disqualified from working with one type of investigational product, such as biologics, could, in theory, continue testing another. The US Food and Drug Administration (FDA) has published a proposal make disqualifications apply to all investigational product types.
“This proposed action of explicitly extending a disqualified investigator’s ineligibility to receive any FDA-regulated test article would help to reduce the risk of additional violations in other FDA- regulated investigations”, said the agency.
Publication of the proposed rule follows changes made by the FDA in August 2009. A month later the US Government Accountability Office (GAO) released a report recommending changes to the disqualification procedures.
Clarification and harmonisation of disqualification regulations are also covered by the proposed rule. Collectively the changes are intended to help ensure data quality, protect trial participants and increase public confidence in the clinical process.
Evidence investigators disqualified in one area continued working in another is minimal, if it exists at all. In fact, 75 per cent of disqualification cases from 1998 to 2007 were settled by consent decrees which prohibited the investigator from working with other FDA-regulated test articles.
However, the GAO said, and the FDA agrees, the loophole for the 20 per cent who are disqualified but could, in theory, work with other FDA-regulated test articles, should be closed. Based on historic disqualification rates, up to two investigators a year will be affected by the rule.
Interested parties have until July 12 to submit written comments in response to the document.