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  • WHO official demands integrity in clinical trials

A top World Health Organisation (WHO) official has criticised the “inappropriate involvement” of commercial sponsors in clinical trials of new drugs. In a strongly worded editorial in the latest WHO Bulletin Jonathan Quick, director of essential drugs and medicines policy at the WHO, also calls for new guidelines to protect clinical investigators against commercial pressures.

Quick suggests that a code of practice — similar to the 1964 Helsinki Declaration on the ethics of medical research on human subjects — could be drawn up to clarify the rights and obligations of clinical researchers. Such a declaration would safeguard intellectual independence of investigators both in terms of trial design and the right to publish negative results.

Continued progress in the development of effective medicines “depends critically on the quality of clinical trials”, Quick points out. He refers to antiretroviral HIV drugs that have been developed over the last decade as a success story in combating AIDS, and emphasises the need to ensure access to such medicines both in the North and South.

Quick identifies three factors as threats to reliable research and development: financial conflicts of interest on the part of researchers; pressure from industry partners on the design and management of trials; and bias in the publication of research findings.

While it may not be realistically possible to “stem the tide of commercial influence”, Quick says, sponsors of clinical trials must allow scientists to conduct their research independently.

Quick’s article concludes, “it is in the interest of all stakeholders, including pharmaceutical firms, that the evidence on which clinical and policy decisions are based meets the highest standards of scientific and ethical integrity”.

In a move that echoes Quick’s comments, the British Committee on Publication Ethics (COPE) has called for a new national body to deal with misconduct in biomedical research. The announcement follows a meeting in October where “there was unanimous agreement that a national panel was required,” according to the chair of COPE, Michael Farthing.

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