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    Somente Metadadados
    Viés de publicação em ensaios clínicos sobre anticorpos monoclonais e repercussão jurídica do direito fundamental à saúde baseada em evidências
    (Universidade Federal de São Paulo (UNIFESP), 2014-12-31) Santos, Douglas Henrique Marin dos [UNIFESP]; Atallah, Alvaro Nagib Atallah [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Aims: We aimed to assess the proportion of publication and reporting of results of clinical trials on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab registered at ClinicalTrials.gov. We also aimed to evaluate the circumstances associated to publications bias and the effectiveness of FDAAA legislation in controlling it. Methods: In this cross-sectional, we searched ClinicalTrials.gov for protocols of interventional studies, phases III and IV, on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab, interventional (n = 243). After, we searched Pubmed, Embase, Lilacs, Cochrane Central and Google Scholar in order to evaluate and find published papers. Results: Among the 243 trials that comprised our initial sample, 178 (?73,2%) were published and 73 (?30%) had results reported at ClinicalTrials.gov. Industry sponsored trials were 169 (? 69.5%). Regarding the methodological quality of protocols, 159 (?65,4%) trials were designed with two or more comparison groups (intervention versus control), 149 (?61,3%) were randomized and 84 (?34,5%) were masked. Only 82 trials (?33,7%) were cumulatively designed with control groups, randomized allocation of participants, and masking. Among published studies (n=178), 118 (?66,3%) reported positive results, 18 (? 10%) reported negative results, 11 (?6,2%) found neutral or inconclusive results, and 24 (?13,5%) were partially positive. In the subsample of trials under FDAAA mandatory reporting (n=57), 48 (?84.2%) were published and 40 (?70,2%) had their results disclosed at ClinicalTrials.gov. Placebo-controlled trials were significantly more common among industry-funded trials when compared with independent trials (n=44/169 [26%] versus 9/74 [?12,2%]; p=0,025). Treatment as usual controlled trials were significantly more common among independent studies when compared to industry-funded trials (n=36/74 [?48.6%] versus 44/169 [?26%]; p<0,001). Conclusions: Publication bias in clinical trials is intense, despite the nature of intervention investigated (in this case, monoclonal antibodies). The source of funding (independent or industry) did not change the patterns of publication, suggesting that publication bias is evenly spread among different sponsors. However, studies involving placebo or single arm studies were more common in industry-funded trials. Our findings also suggest a higher prevalence of positive results among published trials. Lack of transparency, therefore, goes beyond selective publications and encompasses poor designed and biased protocols. Clinical trials subject to the FDAAA legislation had a greater proportion of published studies and disclosed results at ClinicalTrials.gov, suggesting the effectiveness of U.S. law in controlling publication bias and expanding in clinical research.