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A
couple wearing masks to prevent contracting Middle East Respiratory Syndrome
(MERS) looks at each other as they ride on an escalator in Seoul, South Korea,
June 11, 2015. REUTERS/Kim Hong-Ji
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By Kate
Kelland (Reuters)
Anyone
who goes down with flu in Europe this winter could be asked to enroll in a
randomized clinical trial in which they will either be given a drug, which may
or may not work, or standard advice to take bed rest and paracetamol.
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.”
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The
gloved hands of an army nurse are seen during a demonstration of an isolation
chamber for the treatment of infectious disease patients, at the Germany army
medical centre, Bundeswehr Clinc, in Koblenz October 16, 2014. REUTERS/Ralph
Orlowski
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“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 <ROG.VX> Tamiflu and GlaxoSmithKline’s
<GSK.L> 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.
“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)
(c)
Copyright Thomson Reuters 2015. Culled from newsdaily.com
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