Professional Documents
Culture Documents
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p However, a lot has changed in the clinical
research scenario since then.
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p The use of Indians µfor the benefit of the
Western world¶ has extensively been criticized.
Before jumping into any ill-informed
conclusions, it would be worthwhile to
understand the benefits of clinical research.
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p Have access to the latest medication or treatment
modalities.
p Get free medical care, which includes costs of
investigations and medicine.
p Enter into the trial voluntarily after signing an informed
consent.
p Are not bound to continue to participate in the trial (The
consent can be withdrawn at any time).
p Receive more frequent and focused consultations leading
to an improvement in the quality of healthcare.
p Get first hand experience with the most recent drugs
p Get global recognition working on the same platform
as other international experts on the project
p Get extensive training in the internationally accepted
Good Clinical Practice (GCP) and Good Laboratory
Practice (GLP) guidelines
p Get an opportunity for publication
p Have access to the latest medicines for their patients
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CLINICAL TRIAL ACTIVITIES IN ASIA ALL STUDIES
www.clinicaltrials.gov-Snapshot: 7 Feb 2008
Countries with more than 100 studies listed
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45 6234
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8 ,6 ,33
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65 252
552 95
53, 463
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& 8 32 93
3 453
19 4555
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p ver the last five years India has become a preferred
destination for global trials.
p This globalization has brought challenge of compliance to
global regulatory and ethical norms.
p To meet this demand, Indian regulatory system had been on
an evolving mode for quite some time now.
p From an era of bureaucratic hurdles, delayed approval
timelines and lenient attitude towards misconducts, it is
rapidly moving to an era of fast- track approvals, active
inspection of sites and mandatory registration of Indian trials
in national trial registry in an attempt to meet global
regulatory expectations of stringency and transparency.
p The government is aggressively promoting India as a
location for clinical trials even before setting up the
structure to regulate the conduct of these trials.
p Clinical trials are conducted by contract research
organisations which are making inroads into small towns,
identifying trial sites in small private hospitals and
developing databases of potential trial participants.
p Medical professionals are given substantial incentives to
recruit their own patients into these trials thus creating a
major conflict of interest that threatens the well-being of
patients.
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p Another welcome initiative taken by the DCGI is to
conduct inspection of trial sites.
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p Clinical research holds tremendous scope and
opportunities not only for trained medical,
pharmaceutical and paramedical professionals,
but also for regulatory authorities, government
and the society at large
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