Beyond registration—measuring the public-health potential of new treatments for malaria in Africa

• Published in: The Lancet infectious diseases 2006, Vol.6 (1), p.46-52
• Main Authors: Lang, Trudie, Hughes, Dyfrig, Kanyok, Tom, Kengeya-Kayondo, Jane, Marsh, Vicki, Haaland, Ane, Pirmohamed, Munir, Winstanley, Peter
• Format: Article
• Language: English
• Subjects: Africa; Antimalarials - administration & dosage; Antimalarials - adverse effects; Antimalarials - therapeutic use; Biological and medical sciences; Clinical Trials, Phase IV as Topic; Drug Costs; Female; Human protozoal diseases; Humans; Infectious diseases; Malaria; Malaria - drug therapy; Malaria - epidemiology; Medical sciences; Parasitic diseases; Pregnancy; Pregnancy Complications, Parasitic - drug therapy; Protozoal diseases; Public health; Public private partnerships; Vector-borne diseases
• ISSN: 1473-3099; 1474-4457
• DOI: 10.1016/S1473-3099(05)70326-1

Malaria claims over one million lives a year in some of the poorest countries of the world. Affected populations and governments cannot afford to pay for expensive new therapies. Most antimalarial treatments are purchased from local shops and administered in the home. These factors make for a complex set of requirements for any new treatment for malaria if a substantial reduction in mortality is ever to be achieved. Thankfully there are several treatments being developed, mostly within public–private partnerships. Typically, the goal of public–private partnerships is the granting of a product license, so work plans end after phase III trials. As these drugs will ultimately be used unsupervised, malaria control programme managers will require further data on safety and whether the drug is as efficacious when used outside of controlled clinical trials before allowing widespread use of these new products. These data need to be collected in highly specific phase IV programmes. We explain why public–private partnerships should extend their development plans well beyond drug registration, and set out the requirements of such a programme. We aim to generate debate and discussion so that guidelines that are internationally accepted and adhered to can be developed not only for antimalarials but for all drugs that are being developed specifically for use in resource-poor settings.