Quality of randomised controlled trials

Editor—The Save European Science campaign (www.SaveEuropeanResearch.org) was launched on 9 December 2003 out of concern for the future of academic and investigator led research in Europe with the advent of the European Union clinical trials directive (see p 240). It was launched from a cancer platform but is inclusive in spirit and has already gained momentum in cardiology, dermatology, and psychiatry. The directive was written and passed after minimal consultation with interested parties in the member states. Frustration at the inevitability of its arrival in May 2004 and the lack of a process to alter its course was much discussed at medical conferences and meetings around the world last year. This concern is reflected in the fervour with which researchers from all over Europe and the world have signed the letter to MEPs on the campaign’s website. It starts, “why did the European Union decide to stop cancer research,” and by 15 January more than 2000 researchers had signed. The directive raises the bar in terms of quality and reporting standards for all research. The pharmaceutical industry has understandably accepted this as an achievable minor inconvenience. What is new is that this is now the minimum standard for all clinical research regardless of the financial backing or goal of the project. Under the directive all investigators must take on more paperwork, liability, reporting, and cost burden. Little was wrong with the processes of academic or investigator led research in the European Union in the first place. Many important medical breakthroughs in recent times have been a product of this mechanism. Several eminent American and Australasian researchers have signed the letter, with messages of support that they consider it bad news for the development of medicine if European academia is shut out. To be updated on the progress of this campaign, please sign the letter and provide an email address to receive regular reports. Brian Moulton chief executive officer Irish Clinical Oncology Research Group, 120 Pembroke Road, Ballsbridge, Dublin 4, Republic of Ireland [email protected]