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Returning to Italy from Dublin, where the XIV Cochrane Colloquium took place, we had the opportunity to reflect on the main purpose of the colloquium, which was “… to plan for the future and to continue to make progress” (Mike Clarke, Director of the UK Cochrane Centre, http://colloquium.info/welcome.htm (accessed 5 November 2006)).
The Cochrane Collaboration, an international non-profit and independent organisation dedicated to providing up-to-date, accurate information about the effects of healthcare interventions, has been successful in producing and disseminating systematic reviews. Further progress was made during the Colloquium with the development of strategies aimed at increasing the quality of systematic reviews through the improvement of search strategies, critical appraisal of primary studies, data extraction, statistical analysis and reporting. In addition, new initiatives, such as the development of “umbrella” reviews and the use of Cochrane reviews in the production of treatment guidelines, were discussed.
However, there are other key issues, particularly related to the conduct and reporting of drug trials that deserve careful consideration by people involved in evidence-based health care. In this article we discuss these issues and suggest strategies that we believe would improve the clinical implementation of treatments based on the best available evidence.
(1) IMPROVING THE QUALITY OF PHASE III STUDIES
Strategy: changing current regulatory systems for drug approval
For the last 15–20 years systematic reviews have been successful in highlighting the methodological pitfalls that may confound the results and implications of phase III clinical trials (drug trials conducted for regulatory purposes). These pitfalls include a lack of statistical power, the use of placebo arms in disorders where active treatments were available, the use of inappropriate dose regimens, the employment of multiple comparison strategies to identify differences, the use of complex outcome measures that are almost never employed in practice and, lastly, the very short lengths of follow up. Despite recognition of these problems, there has been no significant change in the …