Clinical research physicians develop and test drugs for safety and effectiveness.
They may be physicians, scientists or pharmacists.
Some clinical research physicians are involved in research at all levels.
Others are involved only after the drug is approved for human testing. They
supervise the patient care.
Developing drugs is a long process involving a number of phases. Research
director Christian Marsolais says researchers will run tests on about 1,000
potential new drugs to determine their strengths and weaknesses. They check
for poisons and test to see how effective each of them is.
"Of those 1,000, only about 100 will be successful enough to be selected
for animal testing. Of the 100 that are tested on animals, about 10 compounds
will prove safe and effective enough to use in human testing," he says.
When researchers believe a drug is ready for human testing, they write
a "protocol." It outlines how the drug will be used and how the tests will
be run. The protocol is submitted to health authorities -- the Food and Drug
The FDA either approves or rules against human testing. If human testing
is approved, researchers recruit volunteer patients to participate in the
initial trials. This is usually done through newspaper ads. The actual testing
might be done at various international sites.
Phase one is when the drug is tested on a small group of patients. This
is to assess the drug's safety. Clinical research physicians supervise this
step. The studies are conducted according to a set of detailed guidelines.
The data are carefully monitored and analyzed. Then the research team will
make a recommendation. It can suggest that the pharmaceutical company discontinue
the testing. Or it can say the company should invest funds and time in developing
If the company decides to proceed, the researchers write a report detailing
everything that has been done with the drug to this point. This report is
submitted to the FDA. The federal body must approve further wide-scale research.
If that passes, the researchers move to phase two. Phase two tests for
efficiency. It involves several hundred patients.
Phase three involves several thousand patients. It tests for long-term
efficiency and safety.
It takes 10 to 13 years to develop a drug from start to finish -- at a
cost of about $500 million.
Clinical research physicians generally work in labs. They will often need
to write reports of their findings and recommendations. There are no physical
requirements for this job. Being wheelchair-bound should normally not prevent
you from doing this job.
Test and develop new drugs
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Medical Scientists, Except Epidemiologists
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