Clinical Trials are studies
conducted on human volunteers. The process of discovering a molecule or
pathway and testing it through animal and multiple human phases until
product launch is stretched over 13 – 17 years.
Good Clinical Practice
The International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human
Use (ICH) is unique in bringing together the regulatory
authorities and pharmaceutical industry of Europe, Japan and the US to
discuss scientific and technical aspects of drug registration.
The Food and Drug Administration
The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP.
International Clinical Trials Registry Platform (ICTRP)
To ensure transparency and data integrity,
all trials are mandated to register Clinical Trials before enrolment of
first volunteer. World Health Organization has developed a joint
platform of registries to ease the process for researchers.