European researchers up in arms over new clinical trials edict

Main Category: Public Health
Article Date: 10 Nov 2003 - 0:00 PDT

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European researchers are appealing to their national governments to reject a sweeping new directive on clinical trials. The edict, which must first be incorporated into the law of each European Union (EU) country, is expected to take effect on 1 May 2004.

The directive is intended to standardize and simplify the rules governing clinical trials. But researchers fear that layers of bureaucracy will only add to the regulatory hurdles and cost of clinical trials, without improving patient safety or trial quality (Nat. Med. 7, 1264; 2001).

'There is a real risk that European public health policy makers and national authorities may marginalize key areas of biomedical and health research by developing [these] policies,' says Françoise Meunier, director general of the Brussels-based European Organization for Research and Treatment of Cancer.

The measure proposes one model for all clinical trials, including those sponsored by academia, industry, charities and government bodies.

The model closely resembles one currently used by the pharmaceutical industry and makes researchers responsible for sponsorship, manufacturing authorization and good manufacturing practices (GMP), as well as a huge amount of paperwork on trial authorization and registration, data verification and pharmacovigilance.

Unlike the drug industry, academic centers rarely have the expertise required to build and run GMP-compliant facilities, and some observers already foresee competition with industry for suitable staff. Critics of the directive argue that it was primarily designed with industry in mind, and that the reality of academic trials was ignored.

'The EU rules must move into line with reality and feasibility,' says Jaap Verweij, a researcher at the Erasmus Medical Center in Rotterdam. '[Otherwise], academic clinical research will come to a standstill and global collaboration will cease.'

Under the directive, nationwide trials will be subject to review by a single ethical committee.

But assessing the suitability of staff and locations at distant sites is virtually impossible and is likely to be delegated to the host institutions, notes Simon Thomas, a clinical researcher at the University of Newcastle upon Tyne. As a result, Thomas says, 'independent review of locality issues for multicenter studies will be lost.'

Another issue is cost. According to a study by Cancer Research UK, increased bureaucracy from the legislation will double the paperwork and quadruple the cost of publicly funded clinical trials.

As a result, warns Peter Selby, director of the organization's clinical center at St. James University in Leeds, there will be fewer trials available to patients, and important clinical questions will remain unanswered.

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