IDEAS home Printed from https://ideas.repec.org/a/ids/ijbire/v17y2018i1p128-145.html
   My bibliography  Save this article

The risk of innovation: measuring drug clinical development in Brazil

Author

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

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.

Suggested Citation

  • Michele De Medeiros Rocha & Danilo Garbazza Vieira & Gilson Brito Alves Lima & Emmanuel Paiva De Andrade & Osvaldo Luis Gonçalves Quelhas, 2018. "The risk of innovation: measuring drug clinical development in Brazil," International Journal of Business Innovation and Research, Inderscience Enterprises Ltd, vol. 17(1), pages 128-145.
    • Handle: RePEc:ids:ijbire:v:17:y:2018:i:1:p:128-145
    as

    Download full text from publisher

    File URL: http://www.inderscience.com/link.php?id=94202
    Download Restriction: Access to full text is restricted to subscribers.
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:ids:ijbire:v:17:y:2018:i:1:p:128-145. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sarah Parker (email available below). General contact details of provider: http://www.inderscience.com/browse/index.php?journalID=203 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.