The use of state of the art statistical methodology in biomedical research: the example of methodology for interim analyses in clinical trials

Background: Clintcal research stresses the need for evidence as a basis for . setting research agendas. The extent to which current clinical research I nvolves recent advances in biostatistics is not well known Aim. This manusc ript focuses on the use of interim analyses accumulating data in clinical t rials. Material and Methods: A PubMed scai-cb was conducted for tbe period 1990-2000. Keywords used included 'interim analysis', alpha-spending functi on' and 'early termination', after subsetting to randomised controlled tria ls (RCT), that were 'multicenter' since these particular studies are more l ikely to have external monitoring boards conducting interim analyses. Studi es were grouped by clinical discipline and also by journals of high or low impact index. Results: Thirteen thousand two hundred eighty two articles wi th both 'RCT' and 'multicenter' were found. Of these, the 'interim analysis ' keyword yielded 879 articles, of which only 163 (19%) studies reported th eir methodology. The Percentages varied by clinical discipline and by journ al type, A 25% random sample of the articles were further reviewed to inves tigate the appropriateness of the interim analysis methods used. Discussion : Recent articles In the medical literature attempt to make the interim ana lysis methods more accessible to clinicians. However, further training of s tatisticians involved in clinical trials is needed as well (Rev Med Chile 2 001; 129: 983-8).