Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries
Summary: Background: Investing in late-stage clinical trials, trial sites, and production capacity for new health products could improve access to vaccines, therapeutics, and infectious disease diagnostics in middle-income countries. This study assesses the case for such investment in three of thes...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-07-01
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| Series: | The Lancet Global Health |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214109X22002066 |
| _version_ | 1811226295181246464 |
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| author | Marco Schäferhoff, PhD Armand Zimmerman, MS Mohamed M Diab, MD Wenhui Mao, PhD Vipul Chowdhary, MD Davinder Gill, PhD Robert Karanja, PhD Mziwandile Madikizela, PhD Osondu Ogbuoji, ScD Gavin Yamey, ProfMD |
| author_facet | Marco Schäferhoff, PhD Armand Zimmerman, MS Mohamed M Diab, MD Wenhui Mao, PhD Vipul Chowdhary, MD Davinder Gill, PhD Robert Karanja, PhD Mziwandile Madikizela, PhD Osondu Ogbuoji, ScD Gavin Yamey, ProfMD |
| author_sort | Marco Schäferhoff, PhD |
| collection | DOAJ |
| description | Summary: Background: Investing in late-stage clinical trials, trial sites, and production capacity for new health products could improve access to vaccines, therapeutics, and infectious disease diagnostics in middle-income countries. This study assesses the case for such investment in three of these countries: India, Kenya, and South Africa. Methods: We applied investment case modelling and assessed how many cases, deaths, and disability-adjusted life years (DALYs) could be averted from the development and manufacturing of new technologies (therapeutics and vaccines) in these countries from 2021 to 2036, for five diseases—HIV, tuberculosis, malaria, pneumonia, and diarrhoeal diseases. We also estimated the economic benefits that might accrue from making these investments and we developed benefit–cost ratios for each of the three middle-income countries. Our modelling applies two investment case perspectives: a societal perspective with all costs and benefits measured at the societal level, and a country perspective to estimate how much health and economic benefit accrues to each middle-income country for every dollar invested in clinical trials and manufacturing by the middle-income country government. For each perspective, we modelled two scenarios: one that considers only domestic health and economic benefits; and one that includes regional health and economic benefits. In the regional scenarios, we assumed that new products developed and manufactured in India would benefit eight countries in south Asia, whereas new products developed and manufactured in Kenya would benefit all 21 countries in the Common Market for Eastern and Southern Africa (COMESA). We also assumed that all 16 countries in the Southern African Development Community (SADC) would benefit from products developed and manufactured in South Africa. Findings: From 2021 to 2036, product development and manufacturing in Kenya could avert 4·44 million deaths and 206·27 million DALYs in the COMESA region. In South Africa, it could prevent 5·19 million deaths and 253·83 million DALYs in the SADC region. In India, it could avert 9·76 million deaths and 374·42 million DALYs in south Asia. Economic returns would be especially high if new tools were produced for regional markets rather than for domestic markets only. Under a societal perspective, regional returns outweigh investments by a factor of 20·51 in Kenya, 33·27 in South Africa, and 66·56 in India. Under a country perspective, the regional benefit–cost ratios amount to 60·71 in India, 8·78 in Kenya, and 11·88 in South Africa. Interpretation: Our study supports the creation of regional hubs for clinical trials and product manufacturing compared with narrow national efforts. Funding: Bill & Melinda Gates Foundation. |
| first_indexed | 2024-04-12T09:22:48Z |
| format | Article |
| id | doaj.art-8c72b124b9564bcdb9629cbc2dc7b930 |
| institution | Directory Open Access Journal |
| issn | 2214-109X |
| language | English |
| last_indexed | 2024-04-12T09:22:48Z |
| publishDate | 2022-07-01 |
| publisher | Elsevier |
| record_format | Article |
| series | The Lancet Global Health |
| spelling | doaj.art-8c72b124b9564bcdb9629cbc2dc7b9302022-12-22T03:38:34ZengElsevierThe Lancet Global Health2214-109X2022-07-01107e1045e1052Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countriesMarco Schäferhoff, PhD0Armand Zimmerman, MS1Mohamed M Diab, MD2Wenhui Mao, PhD3Vipul Chowdhary, MD4Davinder Gill, PhD5Robert Karanja, PhD6Mziwandile Madikizela, PhD7Osondu Ogbuoji, ScD8Gavin Yamey, ProfMD9Open Consultants, Berlin, Germany; Correspondence to: Dr Marco Schäferhoff, Open Consultants, Berlin 10437, GermanyCenter for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USACenter for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USACenter for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USAPolicy Cures Research, Sydney, NSW, AustraliaCambridge, MA, USAVillgro Africa, Nairobi, KenyaGraduate School of Technology Management, University of Pretoria, South AfricaCenter for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USACenter for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USASummary: Background: Investing in late-stage clinical trials, trial sites, and production capacity for new health products could improve access to vaccines, therapeutics, and infectious disease diagnostics in middle-income countries. This study assesses the case for such investment in three of these countries: India, Kenya, and South Africa. Methods: We applied investment case modelling and assessed how many cases, deaths, and disability-adjusted life years (DALYs) could be averted from the development and manufacturing of new technologies (therapeutics and vaccines) in these countries from 2021 to 2036, for five diseases—HIV, tuberculosis, malaria, pneumonia, and diarrhoeal diseases. We also estimated the economic benefits that might accrue from making these investments and we developed benefit–cost ratios for each of the three middle-income countries. Our modelling applies two investment case perspectives: a societal perspective with all costs and benefits measured at the societal level, and a country perspective to estimate how much health and economic benefit accrues to each middle-income country for every dollar invested in clinical trials and manufacturing by the middle-income country government. For each perspective, we modelled two scenarios: one that considers only domestic health and economic benefits; and one that includes regional health and economic benefits. In the regional scenarios, we assumed that new products developed and manufactured in India would benefit eight countries in south Asia, whereas new products developed and manufactured in Kenya would benefit all 21 countries in the Common Market for Eastern and Southern Africa (COMESA). We also assumed that all 16 countries in the Southern African Development Community (SADC) would benefit from products developed and manufactured in South Africa. Findings: From 2021 to 2036, product development and manufacturing in Kenya could avert 4·44 million deaths and 206·27 million DALYs in the COMESA region. In South Africa, it could prevent 5·19 million deaths and 253·83 million DALYs in the SADC region. In India, it could avert 9·76 million deaths and 374·42 million DALYs in south Asia. Economic returns would be especially high if new tools were produced for regional markets rather than for domestic markets only. Under a societal perspective, regional returns outweigh investments by a factor of 20·51 in Kenya, 33·27 in South Africa, and 66·56 in India. Under a country perspective, the regional benefit–cost ratios amount to 60·71 in India, 8·78 in Kenya, and 11·88 in South Africa. Interpretation: Our study supports the creation of regional hubs for clinical trials and product manufacturing compared with narrow national efforts. Funding: Bill & Melinda Gates Foundation.http://www.sciencedirect.com/science/article/pii/S2214109X22002066 |
| spellingShingle | Marco Schäferhoff, PhD Armand Zimmerman, MS Mohamed M Diab, MD Wenhui Mao, PhD Vipul Chowdhary, MD Davinder Gill, PhD Robert Karanja, PhD Mziwandile Madikizela, PhD Osondu Ogbuoji, ScD Gavin Yamey, ProfMD Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries The Lancet Global Health |
| title | Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries |
| title_full | Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries |
| title_fullStr | Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries |
| title_full_unstemmed | Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries |
| title_short | Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countries |
| title_sort | investing in late stage clinical trials and manufacturing of product candidates for five major infectious diseases a modelling study of the benefits and costs of investment in three middle income countries |
| url | http://www.sciencedirect.com/science/article/pii/S2214109X22002066 |
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