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Investing in Late-Stage Clinical Trials and Manufacturing of Neglected Disease Product Candidates – Modeling the Benefits and Costs of Investments for Three Middle-Income Countries

92 Pages Posted: 13 Aug 2021

See all articles by Marco Schäferhoff

Marco Schäferhoff

Open Consultants

Armand Zimmerman

Duke University - Duke Global Health Institute; Duke University - Center for Policy Impact in Global Health

Mohamed Mustafa Diab

Center for Policy Impact in Global Health

Wenhui Mao

Duke University - Duke Global Health Institute

Vipul Chowdhary

affiliation not provided to SSRN

Davinder Gill

affiliation not provided to SSRN

Robert Karanja

affiliation not provided to SSRN

Mziwandile Madikizela

affiliation not provided to SSRN

Osondu Ogbuoji

Duke University

Gavin Yamey

Duke Global Health Institute; Duke University - Duke Global Health Institute

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Abstract

Background: Investing in late-stage clinical trials, trial sites and production capacity for neglected disease products could improve access to vaccines, therapeutics, and diagnostics in middle-income countries (MICs). This study assesses the case for such investment in three MICs: India, Kenya, and South Africa.

Methods: We modeled 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. We also estimated the economic benefits that might accrue from making these investments and we develop benefit-cost ratios (BCRs) for each of the three MICs.

Findings: From 2021-2036, product development and manufacturing in Kenya could avert 4.4 million deaths and 206.3 million DALYs in the Common Market for Eastern and Southern Africa (COMESA) region. In South Africa, it could prevent 5.2 million deaths and 253.8 million DALYs in the South African Development Community (SADC) region. In India, it could avert almost 9.8 million deaths and 374.4 million DALYs in Southeast 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 21 in Kenya, 33 in South Africa, and 68 in India.

Interpretation: Our study supports the creation of regional hubs for clinical trials and product manufacturing compared to narrow national efforts.

Funding: This study was funded by a grant from the Bill & Melinda Gates Foundation.

Declaration of Interest: This study was approved by Duke University’s institutional review board (IRB).

Ethical Approval: All authors report grants from Bill & Melinda Gates Foundation during the conduct of the study.Robert Karanja also serves as Chairman of Steering Committee of the Coalition for Health Research & Development (CHReaD), a policy and advocacy coalition that is funded by BMGF - that also funded this study.

Suggested Citation

Schäferhoff, Marco and Zimmerman, Armand and Mustafa Diab, Mohamed and Mao, Wenhui and Chowdhary, Vipul and Gill, Davinder and Karanja, Robert and Madikizela, Mziwandile and Ogbuoji, Osondu and Yamey, Gavin, Investing in Late-Stage Clinical Trials and Manufacturing of Neglected Disease Product Candidates – Modeling the Benefits and Costs of Investments for Three Middle-Income Countries. Available at SSRN: https://ssrn.com/abstract=3904697 or http://dx.doi.org/10.2139/ssrn.3904697

Marco Schäferhoff (Contact Author)

Open Consultants ( email )

Cantianstr. 22
Berlin, Berlin 10437
Germany

Armand Zimmerman

Duke University - Duke Global Health Institute ( email )

310 Trent Drive
Box 90519
Durham, NC 27710
United States

Duke University - Center for Policy Impact in Global Health ( email )

310 Trent Drive
Durham, NC 27710
United States

Mohamed Mustafa Diab

Center for Policy Impact in Global Health ( email )

310 Trent Drive
Box 90519
Durham, NC 27710
United States

HOME PAGE: http://https://globalhealth.duke.edu/people/diab-mohamed-mustafa

Wenhui Mao

Duke University - Duke Global Health Institute ( email )

310 Trent Drive
Box 90519
Durham, NC 27710
United States

Vipul Chowdhary

affiliation not provided to SSRN

Davinder Gill

affiliation not provided to SSRN

Robert Karanja

affiliation not provided to SSRN

Mziwandile Madikizela

affiliation not provided to SSRN

Osondu Ogbuoji

Duke University ( email )

100 Fuqua Drive
Durham, NC 27708-0204
United States

Gavin Yamey

Duke Global Health Institute ( email )

Trent Hall
310 Trent Drive
Durham, NC 27708
United States

Duke University - Duke Global Health Institute ( email )