Developing an Aggregator Mechanism for Late-Stage Clinical Trials of Neglected Disease Product Candidates

98 Pages Posted: 21 Oct 2020

See all articles by Gavin Yamey

Gavin Yamey

Duke Global Health Institute

Marco Schäferhoff

Open Consultants

Mary Moran

Duke University, Center for International and Global Studies

Mohamed Mustafa Diab

Center for Policy Impact in Global Health

Kaci Kennedy McDade

Center for Policy Impact in Global Health, Duke University

Wenhui Mao

Duke University - Duke Global Health Institute

Parth Chodavadia

Duke Global Health Institute

Armand Zimmerman

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

Vipul Chowdhary

affiliation not provided to SSRN

Robert Karanja

affiliation not provided to SSRN

Mziwandile Madikizela

affiliation not provided to SSRN

Osondu Ogbuoji

Duke University - Sanford School of Public Policy

Date Written: October 14, 2020

Abstract

There have been significant improvements in recent years in the early stage development of products for poverty-related and neglected diseases (PRNDs). However, there are still major challenges in the funding of late-stage clinical trials of candidate products for these diseases. For vaccine development specifically, Rappuoli and colleagues recently concluded that “these improvements in the early development process have revealed a new, and possibly more perilous, Valley of Death in the late vaccine development phase.”

There are three major challenges in conducting phase III trials for PRND product development. First, such trials are expensive and companies often shy away from investing in them because there is no commercial market for most PRNDs. Second, there is poor coordination on late-stage trials across R&D initiatives. At present, there is no overarching global mechanism that is “steering the ship”—there is no universally agreed-upon process for prioritizing R&D investments for PRNDs, for selecting the most promising candidates, or for coordinating the multiple, overlapping research programs worldwide. The result is duplication, waste, and ultimately delays in the development of products. Third, current R&D efforts for PRNDs are “top-down”—they are controlled by high-income countries (HICs) and have generally done poorly at including decision-makers from high-burden countries. It is policymakers in low- and middle-income countries (LMICs) who are in the trenches when it comes to controlling PRNDs—yet they are often not at the table when it comes to deciding on what gets funded, where research is conducted, who gets access to intellectual property, and where and how the technologies end up being manufactured. All these steps need to be “globalized” if we are to develop and deploy new control tools.

Keywords: poverty-related and neglected diseases (PRNDs), aggregator mechanism, research and development, clinical trials, antimicrobial resistance, infectious diseases, Covid-19, AIDS, tuberculosis, malaria, public funding for R&D, vaccine, public health

Suggested Citation

Yamey, Gavin and Schäferhoff, Marco and Moran, Mary and Mustafa Diab, Mohamed and McDade, Kaci Kennedy and Mao, Wenhui and Chodavadia, Parth and Zimmerman, Armand and Chowdhary, Vipul and Karanja, Robert and Madikizela, Mziwandile and Ogbuoji, Osondu, Developing an Aggregator Mechanism for Late-Stage Clinical Trials of Neglected Disease Product Candidates (October 14, 2020). Duke Global Working Paper Series No. 23, Available at SSRN: https://ssrn.com/abstract=3711578 or http://dx.doi.org/10.2139/ssrn.3711578

Gavin Yamey (Contact Author)

Duke Global Health Institute ( email )

Trent Hall
310 Trent Drive
Durham, NC 27708
United States

Marco Schäferhoff

Open Consultants ( email )

Cantianstr. 22
Berlin, Berlin 10437
Germany

Mary Moran

Duke University, Center for International and Global Studies ( email )

2204 Erwin Rd, Box 90404
Durham, NC
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

Kaci Kennedy McDade

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

310 Trent Drive
Box 90519
Durham, NC 27710
United States

Wenhui Mao

Duke University - Duke Global Health Institute ( email )

310 Trent Drive
Box 90519
Durham, NC 27710
United States

Parth Chodavadia

Duke Global Health Institute ( email )

310 Trent Drive
Box 90519
Durham, NC 27710
United States
5129485544 (Phone)

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

Vipul Chowdhary

affiliation not provided to SSRN

Robert Karanja

affiliation not provided to SSRN

Mziwandile Madikizela

affiliation not provided to SSRN

Osondu Ogbuoji

Duke University - Sanford School of Public Policy ( email )

Durham, NC

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Downloads
85
Abstract Views
556
rank
353,265
PlumX Metrics