CROs lack oversight, report says; ACRO cries foul

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The majority of Big Pharma companies use CROs to conduct clinical trials in the developing world, but very few could provide evidence that they'd ever disciplined contractors that ran afoul of ethics codes, possibly putting participants at risk, according to a study by the Access to Medicine Foundation.

But ACRO, a trade group for pharma contractors, said the study fails to cite any evidence to back up its assertion that a lack of disciplinary action leaves patients unsafe in the hands of CROs.

The foundation's report takes a wide-ranging look at the practices of the 20 largest drugmakers, but when it came to enforcing CRO behavior, only four of the profiled companies could provide any evidence of taking punitive measures against contractors that violated the Declaration of Helsinki, a nonbinding international code of ethics for human trials.

Excepting the four compliant companies--Merck ($MRK), GlaxoSmithKline ($GSK), Sanofi ($SNY) and Eisai--drugmakers that don't enforce codes of conduct leave patients "vulnerable to clinical malpractice with little recourse to justice," according to the foundation.

ACRO begs to differ. The group says the foundation's report "demonstrates a total lack of understanding of the CRO industry," in that it doesn't account for the internal ethical standards maintained by contractors--especially those that snag partnerships with the 20 biggest drugmakers. Furthermore, ACRO takes serious issue with the claim that CROs are subject to a "lower level of reputational and financial exposure in the event of problems with the trial," which it says is patently false.

"As to reputational and financial risk, CROs actually face more exposure if there is a problem with a trial, because poor performance can be a death knell for a CRO whose primary business is research," ACRO said in a statement. "From the perspective of ACRO members, the sponsor-CRO relationship is built on [a] system of 'trust but verify,' and to suggest anything less is simply uninformed."

- check out the study (pdf)
- read ACRO's response

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