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The
spectrum called clinical research
Sneha
Chrysolite Paul - Chennai
Clinical
trials and research have assumed greater importance with approaching
of product patent era. This has led pharmaceutical companies to
either find new ways to making profits in the generic drug market
or invest in R&D which can be afforded by only very few companies.
Research
Clinical
research can be divided into three phases, namely, chemical analysis,
animal studies and exposure on human studies from phases I to IV.
The three main sources through which research is done are the in-house
research, contract research and research done in universities and
medical institutions.
Mending
the Fence
The
Indian researchers need to be careful with regulations concerning
with:
 The
patents: With patents coming in, Indian research organisations
need to be extremely careful since one slip from the company can
help their competitors. ‘‘One reason why MNCs fear coming
to India,’’ asserts Dr Ashok Kumar, director, Spectra
Clinical Research Centre (SCRC), ‘‘Is the fact that they
cannot do anything if their formula is leaked to a small company.
The small company would not have an office in the US and if they
wanted to sue the company in India it would take years before anything
happens.’’
The
patients: During the phase I to phase III of clinical trials
on humans every detail on the number of patients along with their
names and other medical details need to be documented. But this
is not the case in many Indian hospitals, says Dr Ashok Kumar who
has worked both in India and the USA. ‘‘Sometimes the
hospitals are not even aware of the activities of the doctor.’’
The
players: In India, at present, there is only one big CRO - Quintiles
Spectral, a franchise of US-based Quintiles. The other players include
Synchron and Siro. Ranbaxy has started this service recently. Companies
like Spectra do only site management services that include only
the human trial stage that is held at hospitals.
The
people: These people should be extremely time managed; aware
of pitfalls; good organisation skills; ability to grasp what the
client/ the higher ups want; ethical; able to work on deadlines;
respect and agree by the confidentiality agreement.
The
Trend
The
trend today is to refrain from in-house research due to high costs
involved. An average research cost for big MNCs cost around 600
to 700 million pounds (statistics given by SCRC). This cost have
increased substantially over time.
The
Future
The
year 2005 would bring vast and dynamic changes in the Indian pharmaceutical
industry. Industry analysts believe that IT would be the next revolution
that would hit India. With the United States announcing that they
would increase their percentage of outsourcing clinical trials from
20 per cent to 60 per cent would mean that India would see a lot
more researchers coming to the country. Research laboratories need
to be geared up to this fact and update themselves now. Pharmacy
colleges should educate students to become good researchers. With
a wide variety of diseases prevailing in the country and a sheer
number of diseased people, India could indeed be the gold mine of
clinical research in the near future.
(With
inputs from researchers and management team of Spectra Clinical
Research Centre, Chennai)
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