Drug trials are over too soon, warn doctors

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A study found a number of trials were stopped early after good interim results

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The benefits of new cancer drugs are being "exaggerated" because trials are stopped too soon, research claims.

It says growing numbers of pharmaceutical companies are halting trials - including those for the breast cancer drugs Herceptin and Lapatinib - shortly after receiving good interim results.

And it warns that patients could be at risk if drugs are licensed and rushed into clinics before possible side-effects are identified.

The study by Dr Giovanni Apolone, whose findings are published in the journal Annals of Oncology, analysed 25 controlled trials.

Picked at random, each lasted around 30 months and was stopped early because it showed a benefit to patients.

Dr Apolone, of the Mario Negri Institute for Pharmacological Research in Milan, said: "When we analysed 25 trials over a ten-year period between 1997 and 2007, we found more than 50 per cent were stopped within the past three years.

"While this could guarantee quicker access to the market for companies, it could also lead to an 'immature' evaluation of the benefit and risk balance of new drugs.

"We believe that only untruncated trials can provide the full level of evidence required to safely translate treatments into clinical practice.

"Without such evidence, unsafe and ineffective drugs could be marketed and prescribed, and patients' health could be jeopardised." Three-quarters of the trials were halted after independent monitoring committees said the drugs were so successful, it would be "unethical" to deprive patients of them. Dr Apolone stressed there there was no evidence anything was wrong with the trial results and that he was not questioning the integrity of those monitoring them. Professor David Kerr, editorin-chief of Annals of Oncology, said: "We, as scientists, put a great deal of work and effort into designing appropriate clinical trials, and in all but the rarest of cases we should not rush to abandon those designs in the face of early signs of benefit."

A spokesman for the Association of the British Pharmaceutical Industry said it strongly rejected any suggestion that commercial interests led to trials being halted early.

"The interest of patients is the overriding concern," he added.

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