There is much discussion on how new drugs can be developed for use in developing countries at a p... more There is much discussion on how new drugs can be developed for use in developing countries at a price that makes them accessible to those who need them most. The development of a new antimalarial, chlorproguanil/dapsone (Lapdap), provides an example of a way this can be achieved. The idea of combining chlorproguanil with dapsone came from studies done in east Africa in the 1980s. These studies showed, both in vivo and in vitro, that chlorproguanil/dapsone had advantages over sulphadoxine/pyrimethamine. A public-private partnership was established subsequently to manage a development programme of a fixed ratio tablet of this drug combination. The partnership comprised GlaxoSmithKline (formerly SmithKline Beecham), the World Health Organization (WHO), and the UK's Department for International Development (DFID). All clinical, toxicological, and pharmaceutical chemistry studies are complete and the findings have been submitted for regulatory approval. The question now is how Lapdap...
Transactions of the Royal Society of Tropical Medicine and Hygiene, 2008
The recent increase in funding for diseases endemic in resource-poor countries has led to a progr... more The recent increase in funding for diseases endemic in resource-poor countries has led to a progressive rise in the number of trials conducted in Africa for product development purposes or to answer important questions on reduction of disease burden. This causes an increasing demand for data safety monitoring boards (DSMBs) within Africa, where there is currently a shortage of appropriately skilled people. To address this, and in line with capacity-building efforts directed at improved quality research, AMANET invited the authors to create a curriculum and to train selected Africans with the skills required for members of DSMBs. Based on experience, the facilitators made an overview of clinical trial designs, a comprehensive review of data safety monitoring guidelines and other relevant DSMB governance issues. The wealth of guidelines and recommendations available for establishing and running DSMBs focus mainly on trials set in developed countries. The authors drew from these guidel...
Between March, 2007, and October, 2008, we enrolled healthy children aged 517 months in Kilifi, ... more Between March, 2007, and October, 2008, we enrolled healthy children aged 517 months in Kilifi, Kenya, and Korogwe, Tanzania. Computer-generated block randomisation was used to randomly assign participants (1:1) to receive three doses (at month 0, 1, and 2) of either ...
Malaria claims over one million lives a year in some of the poorest countries of the world. Affec... more 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.
There is much discussion on how new drugs can be developed for use in developing countries at a p... more There is much discussion on how new drugs can be developed for use in developing countries at a price that makes them accessible to those who need them most. The development of a new antimalarial, chlorproguanil/dapsone (Lapdap), provides an example of a way this can be achieved. The idea of combining chlorproguanil with dapsone came from studies done in east Africa in the 1980s. These studies showed, both in vivo and in vitro, that chlorproguanil/dapsone had advantages over sulphadoxine/pyrimethamine. A public-private partnership was established subsequently to manage a development programme of a fixed ratio tablet of this drug combination. The partnership comprised GlaxoSmithKline (formerly SmithKline Beecham), the World Health Organization (WHO), and the UK's Department for International Development (DFID). All clinical, toxicological, and pharmaceutical chemistry studies are complete and the findings have been submitted for regulatory approval. The question now is how Lapdap...
Transactions of the Royal Society of Tropical Medicine and Hygiene, 2008
The recent increase in funding for diseases endemic in resource-poor countries has led to a progr... more The recent increase in funding for diseases endemic in resource-poor countries has led to a progressive rise in the number of trials conducted in Africa for product development purposes or to answer important questions on reduction of disease burden. This causes an increasing demand for data safety monitoring boards (DSMBs) within Africa, where there is currently a shortage of appropriately skilled people. To address this, and in line with capacity-building efforts directed at improved quality research, AMANET invited the authors to create a curriculum and to train selected Africans with the skills required for members of DSMBs. Based on experience, the facilitators made an overview of clinical trial designs, a comprehensive review of data safety monitoring guidelines and other relevant DSMB governance issues. The wealth of guidelines and recommendations available for establishing and running DSMBs focus mainly on trials set in developed countries. The authors drew from these guidel...
Between March, 2007, and October, 2008, we enrolled healthy children aged 517 months in Kilifi, ... more Between March, 2007, and October, 2008, we enrolled healthy children aged 517 months in Kilifi, Kenya, and Korogwe, Tanzania. Computer-generated block randomisation was used to randomly assign participants (1:1) to receive three doses (at month 0, 1, and 2) of either ...
Malaria claims over one million lives a year in some of the poorest countries of the world. Affec... more 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.
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