Title: The risk of innovation: measuring drug clinical development in Brazil

Authors: Michele De Medeiros Rocha; Danilo Garbazza Vieira; Gilson Brito Alves Lima; Emmanuel Paiva De Andrade; Osvaldo Luis Gonçalves Quelhas

Addresses: Engineering School, Federal Fluminense University, Passo da Pátria St., 156 – São Domingos, Niterói – RJ, 24210-240, Brazil ' Engineering School, Federal Fluminense University, Passo da Pátria St., 156 – São Domingos, Niterói – RJ, 24210-240, Brazil ' Engineering School, Federal Fluminense University, Passo da Pátria St., 156 – São Domingos, Niterói – RJ, 24210-240, Brazil ' Engineering School, Federal Fluminense University, Passo da Pátria St., 156 – São Domingos, Niterói – RJ, 24210-240, Brazil ' Engineering School, Federal Fluminense University, Passo da Pátria St., 156 – São Domingos, Niterói – RJ, 24210-240, Brazil

Abstract: Although risk is inherent in innovation, the pharmaceutical sector still leads research and development (R&D) investments. Therefore, the awareness of potential risks is especially important for this sector that spends approximately 70% of the total cost of new drug development on clinical trials. The economic crisis in Europe and its reimbursement system has made emerging countries, like Brazil, potential strategic markets for the return of these high investments. Using a public database (ClinicalTrials.gov), this study estimated the probabilities of failure and success of clinical trials in Brazil up to approval by the regulatory authority. The results showed the risk in conducting phase 3 clinical trials, the most extensive and complex phase, is considered high (26.7%). On the other hand, regulatory approval represents a high success rate, since over 90% of the drugs with positive results in phase 3 were approved by the Brazilian Agency.

Keywords: risk; innovation; pharmaceuticals; drug development; clinical trials; Brazil.

DOI: 10.1504/IJBIR.2018.094202

International Journal of Business Innovation and Research, 2018 Vol.17 No.1, pp.128 - 145

Received: 29 Aug 2016
Accepted: 02 Jun 2017
Published online: 22 Aug 2018 *

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