When the largest Ebola outbreak in history exploded across West Africa in 2014, public health authorities raced to test experimental vaccines and drugs they hoped would quell the massive epidemic.
But the trials process was too slow, and in the end, a massive influx of outside medical help and strict enforcement of measures to prevent ongoing infection were what brought the outbreak under control.
Now, a new report commissioned by the National Academies of Sciences, Engineering, and Medicine attempts to chart a road map for expedited clinical trials for future epidemics, hoping to ensure that the lessons from the devastating Ebola outbreak are not forgotten.
“There will be one. The more we can start now, the better we’ll be,” said Dr. Gerald Keusch, co-chairman of the committee that produced the report.
The report, “Integrating Clinical Research into Epidemic Response: The Ebola Experience,” was released Wednesday.
A number of the recommendations in the nearly 300-page report focus on trying to build up health systems in low-income countries, so that they are better able to spot, respond to, and contribute to research during future disease outbreaks.
That has long been a goal of global public health, but it remains a work in progress. And with the Trump administration’s “America First” philosophy, it is not clear how much funding will be forthcoming from Washington for this type of work in the near future.
“You’re going to pay now, or you’re going to pay much more later, both in terms of money, lives, and morbidity. So that’s the kind of context in which this conversation is going to need proceed,” said Keusch, who is associate director of Boston University’s National Emerging Infectious Diseases Laboratory.
The report also recommends that work be done during times between outbreaks to try to set up flexible study protocols and other tools to fast-track research collaborations, so that they can be utilized when epidemics flare.
Some of these efforts are already in the works, said Dr. Marie-Paule Kieny, an assistant director-general of the World Health Organization and the person who led the WHO’s efforts to accelerate research during the Ebola outbreak.
For instance, discussions are underway to try to streamline the ethics approvals that must be obtained by every organization involved in a clinical trial. Kieny noted that for the trial of an experimental vaccine in Guinea involving Guinea’s department of health, the WHO, Doctors Without Borders, and the government of Norway, independent ethics approvals were required by each.
“And when you have one say, ‘Ah, actually, I don’t like this sentence, I want it changed,’ you have to go back and ask everybody again for approval,” she said.
Debates over the ethics of research during outbreaks aren’t esoteric. For weeks in the summer of 2014, as the world began to fathom the scale of the unfolding disaster in West Africa, researchers and public health authorities argued about whether it would be ethical to conduct clinical trials while the outbreak raged.
A panel of ethicists called together by WHO eventually gave outbreak research a green light. That will likely act as a precedent for future epidemics.
Kieny said discussions are also underway to establish liability rules in advance, so it is clear who bears the responsibility for compensation if a drug or vaccine induces serious side effects during a trial. The thorny question of liability has bedeviled this type of work in the past.
Multiple post-mortems have critiqued the global response to the Ebola crisis and efforts to improve preparedness have ensued. The WHO has identified a priority list of pathogens for which the world needs drugs or vaccines, its so-called R & D Blueprint.
A new organization, known as CEPI — the Coalition for Epidemic Preparedness Innovations — is funding research on vaccines for some of these pathogens, with the goal of getting experimental products to the point where they are ready to test if they are needed.
The report recommends the creation of another new organization, something it calls an international coalition of stakeholders, to coordinate research during epidemics. The body would be made up of governments, academic institutions, funding organizations, and pharmaceutical companies. The WHO should take part, but should not lead the effort, Keusch said.
How the group would be formed and where it would get its authority to set research ground rules was not clear. Nor is it certain that countries that are not at part of this group would feel bound to follow its rules. “If anything, this is a mandate that belongs to WHO,” Kieny said.
Public health has long struggled to do research during outbreaks of emerging diseases. Often the people who would normally write research proposals and funding grants are the same people racing to see patients and figure out the basics of the new threat — how it’s spreading, how to stop it.
In some cases a new disease takes public health officials by complete surprise. SARS is a good example: Scientists hadn’t seen the virus before, so there had been no research done to develop drugs or vaccines. The cupboard was bare but for a few antiviral drugs developed for other diseases that scientists proposed to try against the new foe.
With Ebola, there had been research for years into possible drugs and vaccines and there were quite a few candidates. But almost all of them were very near the start of the development pipeline. And supplies were exceedingly limited. In the early stages of testing of a new drug or vaccine, laboratories make only small batches for animal testing or the first human trials, which involve small numbers of people. The report doesn’t discuss that bottleneck.
Despite the uncertainty of US funding, the Ebola crisis has created a willingness to tackle outbreak preparedness, Keusch suggested. “I think we’re in a somewhat different world now. We really need to be pursuing this, trying to make it happen, in the best way that we properly can.”
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