title: Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.
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.
authors: *Medical Research Council of Zimbabwe, Harare, Zimbabwe; †Social & Scientific Systems, Inc. AIDS Clinical Trials Group, International Site Support, Silver Spring, MD; ‡Department of Medicine, Faculty of Health Sciences, Clinical HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
authors: Paul
authors: P
authors: Ndebele
authors: Christina
authors: C
authors: Blanchard-Horan
authors: Akbar
authors: A
authors: Shahkolahi
authors: Ian
authors: I
authors: Sanne
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D028741:Ethics Committees, Clinical / Q000941:ethics / Q000592:standards*; D028744:Ethics Committees, Research / Q000941:ethics / Q000592:standards*; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control; D006295:Health Resources; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards; D011634:Public Health