I'd like to share with you the story of
one of my patients called Selene Selene
is a housewife and leaves in a rural
district of Cameroon in West Central
Africa six years ago at the time of her
HIV diagnosis she was recruited to
participate in the clinical trial which
was running in her health district at
the time when I first met Celine a
little over a year ago she had gone for
18 months without any antiretroviral
therapy and she was very ill she told me
that she stopped coming to the clinic
when the trial ended because she had no
money for the bus fare and was too ill
to walk the 35 kilometers now during the
clinical trial she'd been given all her
antiretroviral drugs free of charge and
her transportation cost had been covered
by the research funds all of these ended
once the trial was completed leading
Celine with no alternatives she was
unable to tell me the names of the drugs
should receive during the trial or even
what the trial had been about I didn't
bother to ask her what the results of
the trial we're because it seemed
obvious to me that she would have no
clue yet what puzzled me most was Celine
had given her informed consent to be a
part of this trial yet she clearly did
not understand the implications of being
a participant or what would happen to
her once the trial had been completed
now I have shared this story with you as
an example of what can happen to
participants in the clinical trial when
it is poorly conducted maybe this
particular trial yielded exciting
results maybe it even got published in a
high-profile scientific journal maybe it
would inform clinicians around the world
on how to improve on the HIV of the on
the clinical management of HIV patients
but it would have done
so at a price to hundreds of patients
who like Celine were left to their own
devices once the research had been
completed I do not stand here today to
suggest in any way that conducting HIV
clinical trials in developing countries
is bad on the contrary clinical trials
are extremely useful tools and a much
needed to address the burden of disease
in developing countries however the
inequalities that exists between richer
countries and developing countries in
terms of funding pose a real risk for
exploitation especially in a context of
externally funded research sadly enough
the fact remains that a lot of the
studies that are conducted in developing
countries could never be authorized in
the richer countries which fund the
research I am sure you must be asking
yourselves what makes developing
countries especially those in
sub-saharan Africa so attractive for
these HIV clinical trials well in order
for a clinical trial to generate valid
and widely applicable results they need
to be conducted with large numbers of
study participants and preferably on a
population with a high incidence of new
HIV infections sub-saharan Africa
largely fits this description with 22
million people living with HIV an
estimated 70% of the 30 million people
who are infected worldwide also research
within the continent is a lot easier to
conduct due to widespread poverty
endemic diseases and inadequate health
care systems a clinical trial that is
considered to be potentially beneficial
to the population is more likely to be
authorized and in the absence of good
health care systems almost any offer of
medical assistance is accepted as better
than nothing even more problematic
reasons include lower risk of litigation
less rigorous ethical reviews and
populations that are willing to
participate in almost any study that
hints at a cure
as funding for HIV research increases in
developing countries an ethical review
in richer countries become more strict
you can see why this context becomes
very very attractive the high prevalence
of HIV drives researchers to conduct
research that is sometimes
scientifically acceptable but on many
levels ethically questionable how then
can we ensure that in our search for the
Cure we do not take an unfair advantage
of those who are already most affected
by the pandemic I invite you to consider
four areas I think we can focus on in
order to improve the way in which things
are done the first phase is informed
consent now in order for a clinical
trial to be ethically considered
ethically acceptable participants must
be given the relevant information in a
way in which they can understand and
must freely consent to participate in
the trial this is especially important
in developing countries well a lot of
participants consent to research because
they believe it is the only way in which
they can receive medical care or other
benefits consent procedures that are
used in richer countries are often
inappropriate or ineffective in a lot of
developing countries for example it is
counterintuitive to have an illiterate
study participant like Celine sign a
lengthy consent form that they unable to
read let alone understand local
communities need to be more involved in
establishing the criteria for recruiting
participants in clinical trials as well
as the incentives for participation the
information on these trials need to be
given to the potential participants in
linguistically and culturally acceptable
formats the second point I would like
for you to consider is the standard of
care that is provided to participants
within any clinical trial now this is
subject to a lot of debate and
controversy should the control group in
the clinical trial be given the best
current treatment which is available
anywhere in the world or should they be
given an altar
relative standard of care such as the
best current treatment available in the
country in which the research is being
conducted is it fair to evaluate a
treatment regimen which may not be
affordable or accessible to the study
participants once the research has been
completed now in a situation where the
best current treatment is inexpensive
and simple to deliver the answer is
straightforward however the best current
treatment available anywhere in the
world is often very difficult to provide
in developing countries it is important
to assess the potential risk and
benefits of the standard of care which
is to be provided to participants in any
clinical trial and establish one which
is relevant for the study but for the
context of the study and most beneficial
for the participants within the study
that brings us to the third point I
wanted to think about the ethical review
of research an effective system for
reviewing the ethical suitability of
clinical trials is primordial to
safeguard participants within any
clinical trial unfortunately this is
often lacking or inefficient in a lot of
developing countries local governments
need to to set up effective systems for
reviewing the ethical issues around the
clinical trials which are authorized in
different developing countries and they
need to do this by setting up ethical
review committees that are independent
of the government and research sponsors
public accountability needs to be
promoted through transparency an
independent review by non-governmental
and international organizations as
appropriate the final point I'd like for
you to consider tonight is what happens
to participants in the clinical trial
once the research has been completed I
think it is absolutely wrong for
research to begin in the first place
without a clear plan for what would
happen to the participants once the
trial has ended now researchers need to
make every effort to ensure that an
intervention that has been shown to be
beneficial
during a clinical trial is as accessible
to the participant of the child once the
trial has been completed in addition
they should be able to consider the
possibility of introducing and
maintaining effective treatments in the
wider community once the trial ends if
for any reason they feel that this might
not be possible then I think they should
have to ethically justify why the
clinical trial should be conducted in
the first place
now fortunately for Saline our meeting
did not end in my office I was able to
get her enrolled into a free HIV
treatment program closer to her home and
with a support group to help her cope
her story has a positive ending but
there are thousands of others in similar
situations who are much less fortunate
although she may not know this my
encounter with saline has completely
changed the way in which I view HIV
clinical trials in developing countries
and made me even more determined to be
part of the movement to change the way
in which things are done I believe that
every single person listening to me
tonight can be part of that change if
your researcher I hold you to a higher
standard of moral conscience to remain
ethical in your research and not
compromise human welfare in your search
for answers if you work for a funding
agency or from a suitable company I
challenge you to hold your employer's to
fund research that is ethically sound if
you come from a developing country like
myself I urge you to hold your
government to a more thorough review of
the clinical trials which are authorized
in your country yes the reason need for
us to find a cure for HIV to find an
effective vaccine for malaria to find a
diagnostic tool that works for TB but I
believe that we owe it to those who
willingly and selflessly consent to
participate in these clinical trials to
do this in a humane way thank you
you