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Access to Medicines says outsourced clinical trials need to be codified

By Gareth MacDonald+

03-Dec-2012

The group whose comments on sponsor oversight drew criticism from ACRO says the industry group's preferred ‘trust and verify’ model only works if verification efforts are robust.

Last week the Access to Medicines Foundation (AMF) released its 2012 Index that ranks pharmaceutical firms based on their efforts to make drugs available to the developing world according to various criteria.

One of these variables was oversight of contract research organisations (CRO) and the report's conclusion – that few Pharmas do enough to ensure contractors operate in accordance with ethical standards set out in the Declaration of Helsinki – was criticised by the Association of Clinical Research Organisations (ACRO).

Chief among the industry group’s concerns was that the Index lacked data indicating that clinical trials overseen by CROs adhere to lower standards of patient safety, ethics or quality than those conducted by pharmaceutical companies in-house.

AMF spokeswoman Suzanne Wolf told Outsourcing-pharma.com this information was not included because the report was never designed to look at contractor performance “but rather the conduct of pharmaceutical companies in relation to their management of and transparency around the outsourcing of clinical trials to CROs.”

Clinical practices and financial risk

ACRO also voiced concerns about AMF's conclusion that standards need to improve because, increasingly, trials are conducted by CROs "with potentially different clinical practices [from in-house pharma teams] and a lower level of reputational and financial exposure in the event of problems."

Wolf defended the conclusion and responded that because the Declaration of Helsinki is non-binding and open to interpretation "potentially different clinical practices" are possible "we believe that codification of the standards and practices in an outsourced arrangement is crucial.”

Similarly, Wolf said that the comment about “lower level of reputational and financial exposure” referred “to the need for codification of responsibilities and accountabilities in order for any compensation claim of a trial participant not to be limited by the fact that CROs are in general smaller than the pharmaceutical companies hiring or partnering with them.”

Focus on the findings

Wolf also said that stakeholder attention should be focussed on the findings of the report, rather than how any particular industry group chooses to interpret them.

"The submissions of the pharmaceutical companies, which have been analysed in accordance with our published methodology, strongly point to the need for pharmaceutical companies to increase their level of transparency around their use of CROs and to demonstrate more robust enforcement mechanisms to ensure that, should a CRO fall below the required standard of conduct, effective action can be taken to address that in order that risk to trial participants is eliminated or minimised.

ACRO refers in its statement to its view that the relationship between pharmaceutical companies and CROs should be based on a system of “trust but verify”. The findings of the Index indicate that companies need to do a better job of showing they are robust in their activities in relation to the “verify” portion, and that their verification mechanisms need to be more transparent in order to assure national and international stakeholders that their responsibilities towards trial participants are being fully and visibly fulfilled.”

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