The pot is calling the kettle

"extremely inefficient and therefore expensive"

I think the FDA needs to look at themselves first...and right away...

Quality must be backbone of clinical trial process, says FDA deputy

22/05/2007 - Quality needs to be built into every step of the clinical trials process, insists a leading US Food and Drug Administration (FDA) official.

There is a need for extensive standardisation and clear accountability - but also for an acknowledgment that variations do occur and can be accounted for, says Dr Janet Woodcock.

The FDA deputy commissioner and chief medical officer was addressing a recent workshop in Washington on 'Defining and Implementing Quality in Clinical Investigations from Design to Completion', held jointly by the Drug Information Association (DIA) and the FDA's Office of Critical Path Programs.

The workshop was part of the Human Subject Protection and Bioresearch Monitoring Initiative, announced by the FDA in June 2006 and focusing largely on data quality and the oversight of institutional review boards (IRBs). The initiative comes under the broader umbrella of the US agency's Critical Path programme, which aims to modernise and streamline medical product development.

The context for improving quality throughout clinical research was that, while the process generally produced high-quality data, much of the evidence needed to support modern evidence-based medicine never came through, Woodcock noted.

This was the legacy of an "extremely inefficient and therefore expensive" system, in which regulatory burdens and the lack of a stable infrastructure limited the number of clinical questions that could be pursued. Fraud was rare, Woodcock claimed, but when it occurred it might go undetected for some time, tarnishing the reputation of "the research enterprise" and eroding trust when it was eventually discovered.

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