Clinical Research is
a process to make advancement of medical knowledge and improve patient care. A
systematic investigation in human subjects for evaluating the safety and
efficacy of any new drug.
Clinical research is the scientific term to examine the
safety and efficacy of a new medication intended for human healthy living. It
is done before to the launch of the drug into the market. The main purpose of
clinical trials is research, so the studies follow strict protocols. These
protocols protect patients and provide reliable trial results to improved health care.
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Clinical trials can only start after pre-clinical
studies, including laboratory studies like in vitro and in-vivo tests on
animals, which have shown that the experimental drug is considered safe and
effective. Preclinical provide a general pharmacokinetic, pharmacological and toxicological
profile of the new drug obtained from animal’s studies. However, no animal is
sufficiently similar to human’s pharmacokinetics and Pharmacodynamics. Due to
this reason, the experimental drug must also be tested on humans.
Clinical
trial is conducted in four phases, which are mentioned below:
Phase I: To determine safety and
identify adverse event and side effects. Researchers test an experimental drug
or treatment on a small group of healthy human volunteer (20–80) for several
months. If
the drug is successfully passes through this phase 1, then move to the next
level of testing called phase II.
Phase II: To determine whether the
drug does for what it is made for and to further determine
safety and
identify side effects and to identify the common risks of the
drug.
The other important factors that are also considered in this phase are
pharmacokinetics, pharmacodynamics, efficacy at different doses, drug disease
interaction, drug- drug interaction, bioavailability of the drug and finally
the patient's safety. The experimental drug or treatment is given to a
larger group of unhealthy human volunteer (100–300) for several months to several years. When the drug
successfully passes through this phase, then move to the next level of testing
called phase III.
Phase III: To determine and to
confirm its safety and effectiveness, drug disease interactions,
drug-drug interactions, dosage intervals
and finally risk/ benefit of the drug and collect information to
compare the data from standard or equivalent
effective drugs. The experimental drug or treatment is given to
larger group of unhealthy human volunteers (1,000–3,000) for several months to several years. This phase is
the last stage before the drug is clinically approved by FDA as this
phase provides enough information about the experimental drug, if it is safe or
not and if it is safe to be launched in the market.
Phase IV: The long-term effects of drugs or treatment
are studied after the drug is permitted to be sold in the market. This
phase is also known as Post-marketing surveillance studies for toxicity. This
phase may be undertaken by regulatory authorities.
The Food and Drug
Administration is responsible for protecting the public health by assuring the
safety, efficacy and quality of new drugs developed. The FDA approves the drug that
passes all the phases of clinical trial and after that it is made available to
the general public. Schedule “Y” is providing
requirements and guidelines for permission to import and /or manufacture of new
drugs to undertake clinical trials or for sale.
Clinical trials are designed to suite you’re scientific, as
well as regulatory requirements with the known SOPs, ICH, and CFR at Global
Allied Pharmaceuticals (GAP). GAP is committed to providing reliable
information and protecting the volunteers of clinical trials. Unreasonable risk
is not to be tolerated in protecting the safety of the volunteers.
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