Clinical Trials
BY
G.RAAJTILAK 7TH SEM
INTRODUCTION
Clinical research is an important part of the drug discovery
process to ensure the safety and efficacy of any new drug.
Clinical trials as the name suggests are set of experiments
and observations done for clinical research. in human
subjects. They are carried out in search of new treatments,
interventions or tests as a means to prevent, detect, treat or
manage various diseases or medical conditions. Clinical
Trials helps in determining if a new intervention works, its
safety & efficacy, and is it better than already available
treatments.
Phases of
clinical trial
Phase-1
Phase-2
Phase-3
Phase-4
Phase I studies
This phase assess the safety of a drug or device. This is
initial phase of testing, which may take about several
months to complete. This phase usually includes a small
number of healthy volunteers (20 to 100). The purpose of
phase 1 trial is to determine the effect/ effects of the drug
or device on humans including how it is absorbed,
metabolized, and excreted (ADME). This phase also
investigates the dose related side effects. About 70% of
experimental drugs pass this phase of testing
Phase 2 studies
• This phase assesses the efficacy of a drug or device. This is second
phase of testing. It takes several months to two years for
completion, and involves up to several hundred patients. Most
phase II studies are randomized trials where one group of patients
receives the experimental drug, while a second "control" group
receives a standard treatment or placebo. Often these studies ar
e "blinded" which means that neither the patients nor the
researchers know who has received the experimental drug. This
allows researchers to provide the pharmaceutical company and the
FDA with comparative information about the relative safety and
effectiveness of the new drug. About one-third of experimental
drugs successfully complete both Phase I and Phase II studies
Phase 3 studies
This phase assess randomized and blind trials
in several hund red to several tho usand
patients. This is large-scale testing, which
lasts up to several years. It provides the
researchers and regulatory authority with a
more thorough und erstand ing of the
effectiveness of the drug or device, the
benef it s and the range of possible adverse
reactions. About 70% to 90% of drugs that
enter Phase III trial successfully complete this
phase of testing. Once Phase III is complete, a
pharmaceutical company can request FDA
approval for marketing the drug
Phase 4 studies
This phase is also called as Post Marketing Surveillance Trials.
They are conducted after a drug or device has been approved for
consumer sale after approval from regulatory authority.
Pharmaceutical companies have several objectives at this stage:
(1) to compare a drug with other drugs already in the market; (2)
to monitor a drug's long-term effectiveness and impact on a
p ati e nt's qual i ty of l i fe ; and ( 3 ) to d e te rm i ne the c ost-
effectiveness of a drug therapy relative to other available and
new therapies. Phase IV studies can result in a drug or device
being taken off the market or restrictions of use could be placed
on the product depending on the findings in the study
Thank you
