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 Those who agree could be helping the world prepare for the next
potentially deadly disease pandemic as well as helping scientists
who are now desperate to plug gaps in knowledge left by previous
missed opportunities.
Scientists are largely in the dark about how to stop or treat the
slew of never-seen-before global health problems of recent years,
from the emergence of the deadly MERS virus in Saudi Arabia, to a
new killer strain of bird flu in China and an unprecedented Ebola
outbreak in West Africa.
They have been unable even to pin down where they came from.
That is because vital studies to analyze transmission routes and
test experimental drugs or vaccines have simply not been done during
epidemics, disease experts say.
It is a failure of science, they say, that should not be allowed to
happen again.
"Research in all of the epidemics we have faced over the past decade
has been woeful," said Jeremy Farrar, director of the Wellcome Trust
global health foundation and an expert on infectious diseases. "The
world is at risk because there are huge gaps in our knowledge base.
"We don't now have a vaccine for SARS if it came back tomorrow; we
don't know how to treat MERS; it took us six to nine months before
we started clinical trials of vaccines for Ebola and in the meantime
almost 12,000 people lost their lives; and during the H1N1 pandemic,
the number of people randomized into clinical studies was very close
to zero."
"BYZANTINE PROCESS"
Bureaucracy, logistics and lack of forethought are the heart of the
problem, according to Trudie Lang, professor of Global Health
Research at Oxford University who has been working on ways to lower
such barriers.
During the Ebola outbreak that swept through Guinea, Liberia and
Sierra Leone, Lang's team, which specializes in planning and
operating trials in vulnerable populations in difficult settings,
was tasked with setting up a clinical study of a potential Ebola
treatment called brincidofovir.
"It normally takes 18 months to set up a trial, and we did it in 16
weeks," she told Reuters. "But the problem was we were still behind
the curve."
In the 2009 H1N1 "swine flu" pandemic, when many governments had
stockpiled antiviral drugs such as Roche's Tamiflu and
GlaxoSmithKline's Relenza and doctors prescribed them, often as a
preventative measure without a confirmed diagnosis, no proper
randomized clinical trials were conducted to find out for sure
whether they helped.
This has left health officials with little or no concrete evidence
on which to base treatment decisions when the next pandemic flu
strain threatens the world.
"It is a huge pity we haven't made the most of our opportunity to
generate evidence," said Chris Butler, a clinical professor at
Cardiff University's Institute of Primary Care & Public Health, who
is now working on the European-wide winter flu trial he hopes will
help plug the evidence gap.
There is little doubt that launching clinical trials in an outbreak
is fraught with difficulty, partly because a new or rare strain of
disease can infect so many and overwhelm health services and partly
because there are many bureaucratic hurdles.
Lang's team were awarded funds in September 2014 and by January 2015
were able to start the trial, but this coincided with a sharp drop
in the number of patients with Ebola as the West Africa outbreak was
beginning to plateau.
Scientists point to vast amounts of form filling, box ticking,
contract drafting, committee meeting and agreement signing that are
involved in setting up a clinical trial.
"There's a huge industry around making triallists 'walk through
treacle'," said Butler. "There's a myriad of permissions needed.
It's a Byzantine process... which can take months.
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"It gives me a headache just thinking about all the approvals" from
ethics committees, sponsors, lawyers, research and development
leaders and clinicians, he said.
Legal agreements are needed between the suppliers of the product --
the experimental drug, vaccine or other intervention -- and the
people running the trial, the funder and hospitals, clinics or
health centers where patients will be recruited.
In an infectious disease outbreak scenario, particularly a
fast-moving one like with flu or Ebola, these legal issues can be
compounded by competition for access to patients.
During the Ebola epidemic for example, Lang says, there were five or
six different research groups seeking to set up and run clinical
trials in the three most affected countries, each of which already
had limited health systems that had been overwhelmed and crushed by
the outbreak.
"It was ludicrous," she told Reuters. "Because essentially we all
had to fight over the same patients. It was like a land grab, and by
that time the (new) cases were going down."
THINKING AHEAD
Part of the threat of any disease outbreak, be it Ebola in Africa,
the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS)
epidemic, Middle East Respiratory Syndrome (MERS) in Saudi Arabia or
the new H7N9 bird flu in China, is the unknown.
Yet Lang and others say there is nothing to say the sorts of
clinical trials needed in an epidemic cannot largely be drawn up,
agreed, signed and sealed ahead of time.
"We need to have protocols ready to go, we need to have a task force
of research staff in each region on standby to be deployed into the
next outbreak trials," she said.
Legal contracts, for instance, cover broadly the same things for any
trial -- data sharing and storage, patient confidentiality, informed
consent, the timing and publication of results, and the pricing,
production and availability of the product if and when it proves
useful.
And in a rapidly moving outbreak which may be too swift and deadly
to allow for months of organization, a coordinated approach would
overcome the problem of having multiple research groups with not
enough patients.
This would be both scientifically and ethically preferable, said
Lang, since if a trial has to be stopped because it runs out of
participants with the relevant disease, then everyone who has taken
part until then has run a needless risk.
"The main issue is that this needs to be done in days rather than
weeks or months," she said. "That basically means research has to be
embedded in the immediate response to an outbreak, and not come as
an afterthought."
(Reporting by Kate Kelland, editing by Timothy Heritage)
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