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Open Access Debate

The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries

Lydia Kapiriri1, James V Lavery2, Peter A Singer3, Hassan Mshinda4, Lorne Babiuk5 and Abdallah S Daar3*

Author Affiliations

1 Department of Health Aging and Society, McMaster University, 1280 Main St. W, Hamilton, Ontario, L8S 4M4, Canada

2 Centre for Research on Inner City Health and Centre for Global Health Research, Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital & University of Toronto 209 Victoria St, 3rd floor, Toronto, Ontario, M5B 1C6, Canada

3 Centre for Global Health MaRS Centre, South Tower, 101 College Street, Suite 406, Toronto, Ontario, M5G 1L7, Canada

4 Tanzania Commission for Science and Technology, P.O. BOX 4302, Dar es salaam, Tanzania

5 University of Alberta, University of Alberta, 1-20 University Hall, Edmonton, Alberta, T6G 2J9, Canada

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BMC Public Health 2011, 11:811  doi:10.1186/1471-2458-11-811

Published: 18 October 2011

Abstract

Background

Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries.

Discussion

There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials.

Summary

While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.