C
clinical trial.
linical research is highly
regulated asnd complex and
Similarly, the industry has done little
not easy to understand. It is
to highlight the high quality of clinical
governed by international
research being done in India. The
and local guidelines with
narrative of clinical trials in India
a strong focus on patient safety and
seems to be driven by a few instances
confidentiality. We, as an industry,
of transgression rather than the many
have not invested enough in creating
instances of good quality work being
greater awareness and education about
done across the country.
clinical research amongst the public
at large. In addition,
Given the challenges
in the recent past we
in the regulatory
have seen instances of
environment we had in
media misreporting
Patients who
India in the recent past,
and sensationalism
are
an
important
patients who are an
which have only served
beneficiary
in
the
important beneficiary
to misrepresent the
in the clinical research
industry further.
clinical research
process were hesitant
process were
to come out and tell
An example of this
hesitant
to
come
out
their stories. We are
is in the reporting of
and tell their stories. seeing that beginning to
deaths in a clinical
change now with a few
trial. Many reports do
We are seeing that
patients coming forward
not make a distinction
beginning
to
change
to speak of their positive
between the death of a
now
experience in clinical
patient in a clinical trial
trials. This will go a long
and death of a patient
way in allaying fear and
due to a clinical trial,
misconceptions about clinical research
and mislead the public into believing
amongst the public at large.
that clinical trials are the cause for a
large number of deaths. The death of a
Overall, advancements in technology
patient in a clinical trial could be due to
are playing an increasingly important
various reasons, including the natural
role in our understanding and
progression of a disease the patient
management of healthcare and
suffers from, other underlying diseases
disease. These advancements are also
the patient has or something totally
unrelated like an accident. All deaths of a impacting the way clinical trials are
patient in a clinical trial, whether related being conducted and managed with
technology driving end-to-end customer
or not, have to be reported to regulatory
value, incorporating design, execution,
authorities and the distinction needs
engagement and commercialization
to be made when reporting deaths in a
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