Science  30 May 2003:
Vol. 300, Issue 5624, pp. 1353

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  1. Clinical Trials Face European Directive

    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

  2. Biodiversity Ticker Tapes

    LONDON—The decade-old Biodiversity Treaty, long derided as a feel-good statement on the health of the planet, could soon get a boost. Meeting here last week, delegates to the United Nations Convention on Biological Diversity asked the U.N.'s World Conservation Monitoring Centre (WCMC) in Cambridge, U.K., to develop a list of 10 or so indicators that governments could use to track biodiversity health.


    Biodiversity advocates hope the list will help spur government efforts to monitor biodiversity loss. “You don't know what you've got until it's gone,” warned WCMC director Mark Collins, quoting folk legend Joni Mitchell. Possible gauges include the World Conservation Union's Red List of endangered species and an economic approach called the Natural Capital Index studied by the Dutch government. WCMC plans to issue its report this summer.

  3. Gates Invests in Diagnostics

    The Bill & Melinda Gates Foundation has donated $30 million to help develop better diagnostic tests for some of the world's most deadly diseases. The money will be distributed through the new Foundation for Innovative New Diagnostics (FIND) in Geneva, in close collaboration with the World Health Organization's (WHO's) Special Programme for Research and Training in Tropical Diseases.

    The lack of fast and accurate diagnostic tests bedevils efforts to control many infectious diseases, especially in developing countries. For instance, the current sputum test for tuberculosis—FIND's first target—is over a century old, time-consuming, and not very reliable. FIND, led by Giorgio Roscigno, a former development director at the Global Alliance for TB Drug Development in New York City, is hoping to develop the science behind new tests and help them reach the market by working with industry, WHO, and others.

    “It's a great initiative,” says Carol Nacy, CEO of Sequella, a Rockville, Maryland, company specializing in new tools to fight TB. “We need better diagnostics really badly.”