CAMBRIDGE, U.K.--A controversial European Union directive may force researchers to abandon or delay scores of clinical trials across the continent. Critics say the edict--an attempt to standardize the rules governing clinical trials in E.U. member states--imperils trials run by public agencies and nonprofits. "It could severely reduce or stop our trials," says Richard Sullivan, head of clinical programs at Cancer Research UK (CRUK), a charity in London that spends more than $16 million a year on clinical trials.
As Science went to press, the chiefs of several major U.K. biomedical organizations--including the Medical Research Council and CRUK--were finalizing a letter to Health Secretary Alan Milburn that outlines their concerns about draft regulations from the U.K.'s Medicines and Health Care Products Regulatory Agency. The agency released the rules earlier this month in response to the E.U. directive.
One issue is cost. CRUK predicts that new requirements, such as additional toxicology tests, could quadruple trial costs without significantly improving patient benefits. More problematic, however, is a requirement that each trial have a single sponsor that, according to CRUK, would be "legally liable for failures ... regardless of who was responsible." Commercial trials typically have such a sole sponsor, but academic and nonprofit studies may have multiple partners.
At stake, says Sullivan, are trials that drug companies rarely pursue, including those aimed at improving regimens of drugs already on the market or developing drugs for rare and childhood cancers. Moreover, almost all tissue banks exploited in academic research are built up with samples donated by patients in noncommercial clinical trials, notes Sullivan, who also serves as vice chair of the European Cancer Research Managers Forum.
The view from continental Europe is equally glum. "All multidisciplinary academic trials" not funded by drug companies could be affected, predicts Françoise Meunier, director-general of the European Organisation for Research and Treatment of Cancer.
Sullivan sees the letter to Milburn as "an opening shot" in a battle to convince the government to revise the proposal before it becomes law next year. European clinical trial experts will press their case with E.U. officials next month at a Brussels summit on the directive
