Come valutare i risultati di una sperimentazione clinica: Assessing results of clinical trials

Abstract

The basic aspects to be taken into consideration when assessing clinical trials are discussed, with reference to both the method set up and assessment of the results. Evaluation of the methods should take into account: a) study plausibility and relevance, b) adequacy of the aims, study programme and end points, c) coherence of selection criteria with the study aims, d) correctness and adequacy of procedures for assigning treatments, with any masking procedures if necessary, e) correctness and adequacy of sample size and statistical analysis procedures. Assessment of results should take into account: a) if data are clearly summed up in tables and graphs, b) if the analysis is based on “intention to treat” or “by treatment”, c) if statistical test results are correctly written, if the test used is one or two tail, if confidence limits are given, d) if the clinical relevance of any positive result is mentioned, e) if any positive result comes from a series of multiple comparisons or from a subgroup analysis.