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Sponsor oversight of CROs is lacking according to report; ACRO responds

By Gareth Macdonald , 29-Nov-2012
Last updated the 30-Nov-2012 at 09:06 GMT

Pharmaceutical sponsors are not doing enough to ensure the CROs they work with conduct trials safely and ethically, according to a new report.

The study by the Netherlands-based Access to Medicine Foundation assessed industry efforts to improve access to medicines in the developing world and found that it “is doing more than it was two years ago, with GSK still outperforming its peers, but an expanding group of leaders closing the gap.”

One area of criticism however was the drug industry’s interaction with contract research organizations (CRO), particularly how sponsors go about ensuring that research is conducted and whether it complies with the Declaration of Helsinki .

“Company accountability involves ensuring the wellbeing of trial participants through adequate due diligence in selecting these contractors, monitoring how they conduct the trials and willingness to enforce codes of conduct with disciplinary action.

However, only four companies [Merck & Co., Sanofi, GlaxoSmithKline and Eisai] provided evidence that they use disciplinary measures to enforce codes of conduct with their CROs to ensure that trials of their products are conducted safely and ethically.”

ACRO responds

CRO industry group ACRO was quick to respond, arguing that the Foundation’s conclusions “fundamentally misrepresents the relationship between research sponsors and CROs and demonstrates a total lack of understanding of the CRO industry.”

Chief among ACRO’s criticisms is that the report lacks data to support the suggestion that trials overseen by CROs adhere to lower standards of patient safety, ethics or quality which, according to ACRO, “is because no such evidence exists.”

The group also rejected the idea that increase drug industry use of CRO means more different research practices are used and the suggestion that third party researchers face lower level of reputational and financial exposure in the event of problems with the trial.

Instead ACRO argues that: “One of the great benefits that CROs bring to the drug development process is a level of global standards and practices that ensure trials are conducted to the same high standards anywhere in the world.

“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. In this

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