How and why clinical trials are used in drug
development:

 

Clinical
trials help doctors understand how to treat a particular disease or condition.
It may benefit people in the future.

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Clinical
research refers to studies, or trials, that are done in people.  Studies on human participants are designed to
answer specific questions about biomedical uncertainties including new
treatments (such as vaccines, drugs, dietary choices, dietary supplements, and
medical devices).

 

Trials
may take place with the objective of repeating previous events to try and get
the same evidence. Others may be solely testing a new drug/treatment and
observing reactions. And, there are randomized controlled trials where some
people may receive a placebo to see if a control group will differ to one
receiving a new drug. This can be done using the single
or double blind practice. Single involves
the subject not knowing whether the drug is a placebo or not. With a
double blind trial, the information to if the drug is a placebo or not is withheld from the subject and the person administering
it, this prevents biases.

 

Phases
of trials:

Preclinical – This is the stage where research
is carried out to discover how a desired target could be reached.

 

Phase 1 – A small number of people, who may be healthy volunteers, are given the medicine. The
drug is being trialled in human volunteers for the first time. Researchers test
for side effects and calculate what the correct
dose might be to use in treatment. They start with small doses and only
increase the dose if the volunteers don’t experience any side effects.

 

Phase 2- The new medicine is tested on a larger group of people who are ill. This is to
get a better idea of its effects in the short term.

 

Phase 3- This is carried out on medicines that
have passed phases one and two. The medicine is tested in larger groups of
people who are ill, and compared against an
existing treatment or a placebo to see if it’s better in practice and if
it has important side effects. Trials often last a year or more and involve
several thousand patients.

 

Phase 4 – The drug has been licenced. There is sufficient information about
the side affects.

 

 

The role of NICE in providing guidelines on clinical
practise:

 

Standing
for The National Institute for Health and Care Excellence, NICE improve health
and social care through evidence based guidance from clinical trial as
previously mentioned.

They
publish guidelines for four areas in medicine:

 

-The use
of health technologies within the NHS.

-Clinical
practice and guidance on the appropriate treatment for people with specific
diseases and conditions.

-Guidance
for public sector workers on health promotion and ill-health avoidance

-Guidance
for social care services and users.

 

These
appraisals are based primarily on evaluations of likelihood of producing useful
results (efficacy) and cost–effectiveness in various circumstances.

 

 

Importance of economic considerations in the
production of guidelines:

 

The NHS
has a limited budget and a vast number of potential spending options so there
needs to be a process involving the decision of how much gets spent on what.
Economic evaluations are carried out within a health technology assessment
framework (HTAF) to compare the cost-effectiveness of alternative means and to
consider the opportunity cost associated with their decisions(how much money
can be made off of the item under trial).

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