Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings

J Acquir Immune Defic Syndr. 2014 Jan 1;65 Suppl 1(0 1):S29-31. doi: 10.1097/QAI.0000000000000037.

Abstract

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Clinical Trials as Topic / ethics
  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / standards*
  • Drug and Narcotic Control / legislation & jurisprudence
  • Ethics Committees, Clinical / ethics
  • Ethics Committees, Clinical / standards*
  • Ethics Committees, Research / ethics
  • Ethics Committees, Research / standards*
  • Guidelines as Topic
  • HIV Infections / drug therapy
  • HIV Infections / prevention & control
  • Health Resources*
  • Humans
  • International Cooperation* / legislation & jurisprudence
  • Multicenter Studies as Topic / ethics
  • Multicenter Studies as Topic / legislation & jurisprudence
  • Multicenter Studies as Topic / standards
  • Public Health