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FDA, WHO criticise integrity of data at contract research firm Semler

Published on 25/04/16 at 09:30am

The US Food and Drug Administration and the World Health Organisation have raised serious concerns related to violations of good laboratory and clinical practices at Indian-based contract-researchers, Semler Research.

The investigation from the WHO revealed that the “manipulation of at least five studies over an extended period of time indicates this is a common practice.” The investigators concluded that this was not the result of an isolated issue confined to within a certain section of the company. They add: “WHO is of the impression that to execute this type of manipulation several staff members on various levels within the organisation have to be collaborating and coordinating.”

They pinpointed trials into five specific drugs that were of particular concern, including atazanavir, acetazolamide, celecoxib, saquinavir and lamivudine. Despite previous warnings, the results of the latest WHO investigation deem Semler to not have implemented the necessary changes. They conclude: “Medicines whose data is manipulated or otherwise associated with implausible evaluations are associated with unquantifiable risks due to unknown safety and efficacy and thus cannot be trusted to bring patients the desired level of benefit.”

The FDA, meanwhile, has issued a notice to all sponsors of New Drug Applications and Abbreviated New Drug Applications that all studies conducted by Semler Research are not acceptable as a result of data integrity concerns.  Any company needing to redo clinical studies as a result is sure to incur high costs.

To read a full copy of the WHO report, please click here.

Sean Murray

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