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A compressive review on “The Evolution and Impact of Good Clinical Practice (GCP) Guidelines in Modern Clinical Research”
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Good Clinical Practice (GCP) guidelines for the
ethical and scientific foundation for the conduct of
clinical research involving human subjects. The
development of GCP has been a response to
historical ethical breaches and the increasing need
for global harmonization in clinical research
standards. Beginning with early ethical codes like
the Nuremberg Code and the Declaration of
Helsinki, and catalyzed by events such as the
thalidomide tragedy and the Tuskegee Syphilis
Study, the evolution of GCP reflects society’s
growing recognition of the need to safeguard the
rights, safety, and well-being of research
participants. The formalization of GCP through the
International Council for Harmonisation (ICH) in
1996 established a unified global standard that
integrates ethical considerations with rigorous
scientific methodology. Subsequent updates, such
as ICH E6(R2) and the ongoing ICH E6(R3), have
sought to adapt GCP principles to contemporary
research challenges, including technological
advancements, decentralized trials, and real-world
data integration
Title: A compressive review on “The Evolution and Impact of Good Clinical Practice (GCP) Guidelines in Modern Clinical Research”
Description:
Good Clinical Practice (GCP) guidelines for the
ethical and scientific foundation for the conduct of
clinical research involving human subjects.
The
development of GCP has been a response to
historical ethical breaches and the increasing need
for global harmonization in clinical research
standards.
Beginning with early ethical codes like
the Nuremberg Code and the Declaration of
Helsinki, and catalyzed by events such as the
thalidomide tragedy and the Tuskegee Syphilis
Study, the evolution of GCP reflects society’s
growing recognition of the need to safeguard the
rights, safety, and well-being of research
participants.
The formalization of GCP through the
International Council for Harmonisation (ICH) in
1996 established a unified global standard that
integrates ethical considerations with rigorous
scientific methodology.
Subsequent updates, such
as ICH E6(R2) and the ongoing ICH E6(R3), have
sought to adapt GCP principles to contemporary
research challenges, including technological
advancements, decentralized trials, and real-world
data integration.
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