Are CT Regulation Deficiencies a Thing of the Past?


Applied Clinical Trials

Dr Hans-Georg Eichler, senior medical officer at the European Medicines Agency, takes a very measured view of clinical trial regulation. He told Applied Clinical Trials on June 6 that while there had been errors, most of them were in the past.

"Yes, there may still be some rotten apples in the barrel," he said, declining to presume omniscience on whether all industry misdemeanours were identified and sanctioned or neutralised. But his view, expressed on the fringes of a seminar on access to medical research data in the European Parliament, was that the regulatory apparatus was capable of capturing the vast majority of trials conducted in Europe, irrespective of their outcome.

The opportunities for sponsors to conceal unsatisfactory results had been largely closed off, he suggested. "It is unacceptable that any clinical trial should disappear under the rug", he said. And with current requirements to register trials, it was almost impossible too.

But Eichler did express concerns about the risks that can arise from ill-informed or ill-intentioned manipulation of data in metastudies, which anyone can do without authorisation, and can lead to false conclusions that can be damaging to health - and he cited the UK case of the anxieties unjustifiably aroused about MMR vaccines by highly questionable data studies.

Raw data is "a tool that can be put to bad use", he said, cautioning against analysis of published data for ulterior motives, to further careers, to stoke controversy, or to raise personal profile, rather than to bring new scientific understanding. The results could, he warned, be "phantom risks or miracle cures".

Access to data has to be the general rule, he said, but it must be "judicious". And, he suggested, there should also be full transparency on any analysis - notably distinguishing exploratory from confirmatory conclusions.

His remarks provided some counterpoint to the litany of attacks made on drug industry research and on regulators during the course of the seminar. Allegations were repeatedly made by academics and MEPs of deliberate concealment of negative results, and of inbuilt bias driven by commercial considerations. The current debates in the parliament on future EU research funding, and the debates that will start soon on clinical trials (once the European Commission has presented its proposal, scheduled for mid-July), are likely to be heavily influenced by some rooted hostility and suspicion.

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