How developing world concerns need to be part of drug development plans: a case study of four emerging antiretrovirals.
Clinical trials are usually designed to meet registration requirements in developed countries, and do not always address key concerns for use in developing countries. Four late-stage investigational new drugs - rilpivirine, etravirine, raltegravir and maraviroc - show potential to improve antiretroviral therapy. However, a number of issues could limit their use in developing countries, including dose selection, treatment strategy, combination with other drugs, use in specific populations and reliance on expensive tests. Key research questions relevant for developing countries need to be answered early in the drug development process to ensure maximum benefit for the majority.
van Roey
Jens
J
Médecins Sans Frontières, Campaign for Access to Essential Medecins, Rue de Lausanne 78, 1211 Geneva, Switzerland.
von Schoen-Angerer
Tido
T
Ford
Nathan
N
Calmy
Alexandra
A
D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003906:Developing Countries; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D006801:Humans; D012192:Retroviridae Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology
D044966:Anti-Retroviral Agents