Clinical trials are a precise evaluation of novel treatments and will involve testing of new chemical entities, diagnostic methods and therapeutic regimes. They are tested in human volunteers to check for their advantages and risks associated in a sample population in closed conditions.
By enrolling in clinical trials, human subjects can not only participate and play a key role in their own healthcare management, but they can also expose themselves to new treatments and help others by exposing themselves to experimental drug therapies in medical research arena.
What is a clinical trial and who are the main stay in the trial? This procedure involves intensive scientific endeavor that requires experimental tools to evaluate new methods in the form of human subjects who are often prone to hazardous and life threatening chemicals. The vested interests and ill informed personnel knowingly and unknowingly who play the spoil-sport and subsequently pulling this field in jeopardy, Critical evaluation of new drugs in controlled conditions and under strict supervision of a physician/clinician is prime feature of clinical trial settings.
To safeguard the well being of a human who participate in clinical trials, every country has come-up with their own regulations delineated by local regulatory bodies like US FDA, Indian DCGI, Australian TGA etc., and global bodies in turn transpire guidelines popularly called ICH-GCP guidelines. These regulations and guidelines put together act as guiding principles and legislations that help to carry-out clinical trials.
*Written by Guest Author*