Clinical
trials refer to the experimentation and observation part of clinical research.
These trials provide crucial data that can be used to answer different research
problems and questions. Certain ethical guidelines must be followed while
conducting such trials.
This
is where clinical monitoring comes in. Clinical monitoring is periodically
checking that the health of the participant and the efficacy of treatment is
maintained during clinical trials. These can be independent monitors in clinical trials or by government-run
grant-funding agencies.
Independent
monitors are carried out by physicians who are experts in their fields. Their
main objective is to monitor the safety at regular intervals. They fully assess
the purpose and prospective side effects of the trials and ensure that the
required measures are taken. In case of adverse events, they are called to
immediately resolve those problems and write a report on the same.
It
is recommended that the chosen physicians be from a different department or
company altogether to eliminate the possibility of preferential treatment. They
are on the team for the duration of the trials and have access to the
participants’ records at any time during the same.
There
are mainly two kinds of reports given by the independent monitor. The first is
the review report stating the concerns and recommendations they have to the
study investigator.
The
second report is immediate action, which states that quick and swift measures
be taken concerning the nature of the trials. It could also include the
termination of the same.
Independent monitors in clinical
trials in India are strictly implemented. The monitoring services include site assistance
and support, site monitoring, query management, investigator selection etc.
With a large population like India’s, there must be such checks put in place
for the sake of safety.
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