Up to $5B worth of clinical testing deemed 'unnecessary'

Up to 25% of clinical trial procedures administered to patients may be unnecessary, costing the industry up to $5 billion in wasted clinical trial costs each year, according to a new study. And the bottom line represents a ripe target for CROs and drug developers looking to streamline procedures and increase efficiency, a big theme in development circles these days.

To help come to that conclusion, researchers from the Center for the Study of Drug Development at the Tufts University School Medicine examined data from 115 clinical trials and more than 22,000 medical procedures. From that, they discovered that one-fourth of the clinical trial procedures were considered "non-core," or those not required to demonstrate a therapy's safety and efficacy. The study--sponsored by Medidata Solutions ($MDSO)--also showed that non-core procedures represent about 20% of a clinical trial's budget, or an estimated $1 million.

So, why are non-core procedures performed so often if they aren't necessary? Tufts University professor Ken Getz told FierceCRO there are many reasons. "Often as insurance in case that data is requested by a regulatory agency; often as 'nice-to-have' information that may be used to inform future studies about a particular innovation," he said. "Often due to protocol authoring templates or carried over from past protocols despite the fact that the procedures are outdated or irrelevant."

Eliminating non-core procedures could save the industry between $3 billion and $5 billion a year, according to the study. With pharma companies under pressure in recent years to conserve money in research and development, the study can serve as a way for them to cut spending, without sacrificing quality.

"By distinguishing between core and non-core procedures early on in the trial process, this research underscores the critical roles study design and protocol development play in overall clinical trial costs," said Marla Curran, director of clinical statistics at GlaxoSmithKline ($GSK), in a statement. "Even with this study's conservative estimate of the procedures organizations could potentially eliminate, it's clear that the industry can take a closer look at trial design to improve efficiencies while still meeting regulatory requirements."

- read a statement about the study

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