New study addresses issues with epidemic response in developing countries

According to a recent report by the National Academies of Sciences, Engineering, and Medicine, combating the next infectious disease epidemic will rely on strengthening clinical research programs on investigational therapeutics and vaccines in developing countries prior to the next epidemic occurring.

The organization said its report was based in part by the West African Ebola epidemic of 2014-2016, which killed 11,310 people in Guinea, Liberia, and Sierra Leone. The outbreak caused the World Health Organization to declare the epidemic a “public health emergency of international concern.”

A major issue cited by the organization in current epidemic response practices were the costs associated with drug development, which it estimated will take at least 10 years and cost approximately $2.6 billion from initial planning to commercialization. To effectively address those risks, the report suggested placing an emphasis on developing therapeutics and vaccine candidates before an epidemic breaks.

The report added that clinical trials could be more rapidly planned and implemented through Phase 1 or Phase 2 safety trials in advance if emergency response planning included research considerations from the beginning.

To lessen the effect of the next outbreak before it peaks, the organization named seven key steps to launching successful clinical trials including: sharing patient information and establishing standards of care, engaging communities to establish mutual trust, integrating research efforts into response procedures and facilitating stakeholder coordination, prioritizing vaccines and therapies, negotiating contracts, consulting with regulators, and performing independent ethics reviews.

Support for the study was provided by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health and the U.S. Food and Drug Administration.