Marcus Müllner

Implications of the EU directive on clinical trials for emergency medicine.

A laudable attempt by the European Union to implement good clinical practice in the conduct of clinical trials on drugs for human use will, unless amended, make impossible a range of potentially life saving studies after May 2004. Directive 2001/20/EC, adopted in April last year, is an important and comprehensive document.1 It is a cornerstone of a Europe-wide harmonisation of the provisions governing clinical trials and can be expected to foster and facilitate multinational clinical research. It will be adopted by member states before 1 May 2003, and its provisions will be applied from 1 May 2004 at the latest. Several articles in the directive deal with the protection of clinical trial subjects. Article 5 outlines the conditions for research in incapacitated patients unable to give informed consent. The article, however, is framed to address the needs of individuals who are incapacitated for long periods, many even permanently. A clinical trial can only be done if “informed consent of the legal representative has been obtained.” …

Pleasing both authors and readers : A combination of short print articles and longer electronic ones may help us do this

Papers pp 897-914 To succeed, journals need to please both authors and readers. There is, however, a tension between the needs of the two, particularly when the authors are mostly researchers and the readers mostly practitioners. Practitioners like research articles to be short and sweet, whereas researchers want—rightly—to include enough material for critical readers (often other researchers) to be able to appraise the study and if necessary repeat it and also, increasingly, to be able to include it in a systematic review. Journals have struggled with this tension for years, and often the result is that we please nobody. Research among readers consistently shows that research articles are not well read, while many studies have shown that essential data are often missing from research reports. Now the electronic revolution offers us a chance to please both readers and authors simultaneously. Todays BMJ includes four papers where a short version is published in the paper journal and a …

Di Bella's therapy: the last word?: The evidence would be stronger if the researchers had randomised their studies

Papers p 224 and Reviews p 268 Wonder cures for cancer appear regularly. The latest comes from Italian physiologist Luigi Di Bella, whose “multitherapy” comprises a mixture of melatonin, bromocriptine, somatostatin, a solution of retinoids, and, depending on the kind of cancer, either cyclophosphamide or hydroxyurea. Political and media support for Di Bellas treatment led to the courts ruling that Italian hospitals must provide it.1 But research that we publish today (p 224),2 which has already been reported in the media, suggests that the treatment is ineffective and toxic. The research could, however, have been better designed. The researchers, who were funded by the Italian government, conducted 11independent uncontrolled multicentre trials …

Website of the week: Interactive patient simulators

When it comes to diagnosing and treating arrhythmias (p 719) and other potentially life threatening conditions, many doctors feel uneasy. You need lots of training and experience to feel confident in this area. The web lends itself to interactive skills assessment and learning. Imagine you are making your hospital ward round and a patient collapses right in front of you. What would you …

Intelligence, schizophrenia, and the corporate industry

According to a paper in this weeks BMJ (p 819), better childhood mental ability predicts a longer life. Hundreds of promising sites on the web will allow you to measure your intelligence, creativity, sexuality, or emotional intelligence www.selfgrowth.com/test.html is just one of the many collections of links. I tried several of these tests: some are fun, some are …