Non-industry trials under threat in EU

- Last updated on GMT

Related tags: Pharmaceutical industry, Clinical trial, Clinical research, European union

European clinical researchers have launched a campaign calling on
the European Parliament and Commission to repeal a new Directive on
Good Clinical Practice (GCP) on the grounds that it will hinder the
conduct of non-commercial trials.

Implementation of Directive EC/2001/20, which is due to come into effect across the EU by next May, will place "enormous, and possibly insurmountable, obstacles in the way of non-commercial, academically-led, patient-focused clinical research,"​ according to the group.

The researchers' concerns lie in the increased obligations which the Directive imposes on the individual or organisation who must now take total legal and financial responsibility for the clinical trial. This responsibility will include paying for all drug and device costs (even the cost of routine non-investigational aspects of the treatment) while patients are on study.

For example an academic sponsor, rather than a national health service, would have to pay for all the drugs that a patient was receiving, including fully licensed drugs, even if just one component of their treatment was experimental.

The risk is that this will inhibit trials that the pharmaceutical industry has no interest in conducting, for example, one comparing a new and expensive drug to an older, cheaper treatment. Such studies are often designed to explore the best use of scarce resources and to maximise the use of existing medicines, for example by finding new applications for them.

While the pharmaceutical industry can provide this level of funding in support of commercially-inspired trials, charities and academic institutions can not, contends the campaign. As a result, the only studies which will take place in the future will be those run by the drug industry.

One of Europe's top cancer researchers, Martine Piccart of the Breast International Group, one of the founders of the campaign, said: "It is vital that the European politicians understand the necessity to preserve independent investigations by academic researchers, charities and co-operative groups."

The repeal campaign​ was launched a few weeks ago and now has the signatures of approximately 1,500 leading researchers and 15 major international research groups and charities on a petition which will be delivered to every Member of the European Parliament (MEP) and Commissioner.

Examples of critically important, non-commercial research include the trials which led to the discovery of the benefits of aspirin in patients with circulatory disease and the use of magnesium sulphate in the treatment of pre-eclampsia of pregnancy.

Cancer research would be particularly hard-hit, according to John Crown of the Irish Clinical Oncology Research Group. He believes that the trials which led to the cure of childhood leukaemia, and to the development of treatments which enabled women with breast cancer and patients with throat cancer to avoid mutilating surgery, would not have been possible if the regulations had been in place at the time when they were conducted.

Concerns have also been expressed that the regulations might make Europe an unattractive venue for research investment, with consequent knock-on employment and economic effects. In a recent statement, Phillippe Busquin, EU Research Commissioner, acknowledged these problems, and highlighted a worrying downward trend in European research investment by pharmaceutical companies. According to the campaign organisers, the Directive can only accelerate this downward trend.