The risk of innovation: measuring drug clinical development in 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.