title: FDAAA legislation is working, but methodological flaws undermine the reliability of clinical trials: a cross-sectional study.
abstract: The relationship between clinical research and the pharmaceutical industry has placed clinical trials in jeopardy. According to the medical literature, more than 70% of clinical trials are industry-funded. Many of these trials remain unpublished or have methodological flaws that distort their results. In 2007, it was signed into law the Food and Drug Administration Amendments Act (FDAAA), aiming to provide publicly access to a broad range of biomedical information to be made available on the platform ClinicalTrials (available at https://www.clinicaltrials.gov). We accessed ClinicalTrials.gov and evaluated the compliance of researchers and sponsors with the FDAAA. Our sample comprised 243 protocols of clinical trials of biological monoclonal antibodies (mAb) adalimumab, bevacizumab, infliximab, rituximab, and trastuzumab. We demonstrate that the new legislation has positively affected transparency patterns in clinical research, through a significant increase in publication and online reporting rates after the enactment of the law. Poorly designed trials, however, remain a challenge to be overcome, due to a high prevalence of methodological flaws. These flaws affect the quality of clinical information available, breaching ethical duties of sponsors and researchers, as well as the human right to health.
authors.affiliation: Federal University of São Paulo (Unifesp) , São Paulo , Brazil.
authors.forename: Douglas H
authors.initials: DH
authors.lastname: Marin Dos Santos
authors.affiliation: Federal University of São Paulo (Unifesp) , São Paulo , Brazil.
authors.forename: Álvaro N
authors.initials: ÁN
authors.lastname: Atallah
keywords: Clinical trials; Design methods; FDAAA; Right to health; Right to information; Selective publication