title: Impact of regulatory assessment on clinical studies in Brazil.
abstract: BACKGROUND
  Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion.
  
  
  OBJECTIVE
  This article examines the allocation process of clinical studies to Brazil in comparison with other countries, as well as the financial impact of studies not completed due to interruption caused by the delay in the regulatory process.
  
  
  METHODS
  The allocation processes of studies were compared in nine countries with similar stages of economic development and countries in Latin America using the websites http://data.worldbank.org/data-catalog/GDP-rankings-table and http://worldpopulationreview.com and clinicaltrials.gov, comprising 185 countries. The 46 studies sponsored by the pharmaceutical industry underwent an analysis of the regulatory review process.
  
  
  RESULTS
  46 studies sponsored by the industry and submitted in the country between June 2007 and June 2013 were analyzed; 18 (39%) were discontinued due to the delay in obtaining the necessary approvals. For the approved studies, patient recruitment began an average of 11 months after the other countries. It is estimated that 530 Brazilians patients did not have the opportunity to participate in these studies. Financial losses were to the order of 14.6 million dollars for the country, including patient, medication and supplies costs, and expenses.
  
  
  CONCLUSIONS
  Brazil has enormous potential for the realization of clinical studies. Researchers, associations of disabled people and patients with chronic diseases, sponsors and the authorities must work together to develop an approval process that is efficient, predictable and, most of all, transparent. The current regulatory environment must and can be improved and optimized in order to result in tangible benefits for patients, society and the country's scientific development.
authors.affiliation: PhD - Director of Centro de Pesquisas e Análises Clínicas (CCBR), Rio de Janeiro, RJ, Brazil.
authors.forename: Luis Augusto Tavares
authors.initials: LA
authors.lastname: Russo
authors.affiliation: MD, Researcher - Director of Centro de Pesquisas Clínicas. President of the Medical Research Committee of Sociedade Brasileira de Endocrinologia e Metabolismo (SBEM), São Paulo, SP, Brazil.
authors.forename: Freddy Goldberg
authors.initials: FG
authors.lastname: Eliaschewitz
authors.affiliation: MD - Pharmacist and Lecturer of the Medical Research Graduate Program at Faculdade de Ciências Médicas da Santa Casa de São Paulo. Director of Quintiles, São Paulo, SP, Brazil.
authors.forename: Vitor
authors.initials: V
authors.lastname: Harada
authors.affiliation: Pharmacist and MSc in Health Economics - Partner/Owner of Idealclinops - Advisory services in Medical Research and Pharmacoeconomics, São Paulo, SP, Brazil.
authors.forename: Roberta Pereira
authors.initials: RP
authors.lastname: Trefiglio
authors.affiliation: Pharmacist and MBA - Medical Integrated Hospital and Intensive Care Division at Novartis Pharmaceuticals, São Paulo, SP, Brazil.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Picciotti
authors.affiliation: MD, PhD and MBA. Head of the Medical Integrated Hospital and Intensive Care Division at Novartis Pharmaceuticals, São Paulo, SP, Brazil.
authors.forename: Paula Goulart Pinheiro
authors.initials: PG
authors.lastname: Machado
authors.affiliation: MD - Director of Instituto Vis Research. Member of the Board, Sociedade Brasileira de Medicina Farmacêutica. Representative of Associação Médica Brasileira, São Paulo, SP, Brazil.
authors.forename: Gustavo Luiz Ferreira
authors.initials: GL
authors.lastname: Kesselring
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence; D001938:Brazil; D000068456:Clinical Studies as Topic / Q000191:economics / Q000331:legislation & jurisprudence*; D028741:Ethics Committees, Clinical / Q000191:economics / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D033161:Government Regulation; D006801:Humans; D012109:Research Support as Topic; D013997:Time Factors