Importance of Clinical Trial Phases
Clinical trials act as the key medical research tool for advancing medical know-how and patient care.
These trials are conducted when doctors or medical technicians are not sure whether a new clinical
approach is working well with people and is safe. Also, if they want to find out which treatments are
going to work appropriate for specific illness or for a group of people.
Therefore, clinical trial cannot be considered as the first-step in developing a new drug or treatment
modality. Rather, it is one of the many procedures that go into the drug development process. The
research and development for the same generally starts at the bio clinical laboratories in the CRO’s
(Clinical Research Organization). Post extensive research and testing, the medical technicians might test
a promising drug or technique. Later on, there can be a small percentage of volunteers who are willing
to participate in experimental treatments that form a huge part of the clinical trials. Depending on the
result of these trials, treatments and drugs that have proved too useful they are made accessible for
other extensive clinical trials.
Clinical Trial Phases
Clinical trial phases depend on the medical research organizations. Generally there are three or four
phases. Some of them are discussed below:
This is the initial step in testing a new treatment on humans. The clinical researchers might want to
study whether the ideal way to offer a new treatment is through injection, mouth or IV drip. They might
also want to determine the apt dose and the number of times they need to be given to the patient every
day. Simultaneously, they also look out for harmful side effects.
The clinical trials conducted in the Phase 2 determine whether the new treatments have an anticancer
element in them. For instance, is the treatment effective in shrinking tumors and if yes, the kind of
tumors it shrinks. Also whether the treatment improves the outcome of blood tests for certain cancers
and not all kinds.
Post a treatment has demonstrated assured results in Phase 1, 2 and 3 in clinical trials, the Phase III
studies compare the results of people taking the standard treatments for certain cancers in certain
stages with people resorting to any new type of treatment. The researchers all over the country carry
out Phase III clinical trials where many others take part.
Today well known Indian CRO’s conducts clinical trials for various medical studies that include medical
writing, biometrics, Bioanalytical studies, bioequivalence, clinical Pharmacokinetic and studies
dedicated to various therapeutic areas.
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