Clinical research physicians do medical research. They don't just treat
patients in clinics and hospitals, though that might be part of their work.
Some clinical research physicians develop and test drugs for safety and
effectiveness. Others test various non-drug methods for treating medical conditions.
"Many people don't do anything related to drugs," says Dr. Brian Rowe,
whose research and clinical practice focuses on emergency medicine.
"They talk about the term 'clinician scientist' or 'clinician researcher'
-- it is as broad and varied as you can imagine," says Rowe.
"I have a colleague who's a clinician, which means he is required to see
patients in pediatrics, is involved with a lot of resident training, and deals
with other patient care issues. And then in his asthma lab he collects urine,
blood, sputum and does basic science research on mechanisms of inflammation
Some clinical research physicians are involved in research at all levels.
Others are involved only after a drug or treatment is approved for human testing.
They supervise the patient care during clinical trials. That contribution
"The challenging aspect is... getting funding to be able to pursue this
kind of career because certainly this kind of work can't be funded through
funds gathered for patient care," says Dr. Rita K. Cydulka. She's a clinical
research physician in Cleveland.
"The other big challenge is time -- dividing time between clinical responsibility
Clinical research physicians combine the medical knowledge of a doctor
with the inquisitiveness of a scientist.
"Unfortunately, as an emergency physician, and a jack of all trades, I
also have questions of all trades," says Cydulka. "So I come across things
I don't know all the time, and if I can't find the answer already done, I
seek to find it through research."
Research physicians who are focused on drug research write a "protocol"
when they believe a drug is ready for human testing. The protocol outlines
how the drug will be used and how the tests will be run. The protocol is submitted
to federal health authorities for approval if it is a new treatment.
If human testing is approved, volunteer patients are recruited to participate
in the initial trials. This is usually done through newspaper ads or physician
encounters. 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
phase is performed to assess the drug's safety. Clinical research physicians
supervise this step. The studies are conducted according to a set of detailed
The data are carefully monitored and analyzed. Then the research team makes
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 research team prepares a report
detailing everything that has been done with the drug to this point. This
report is submitted to the federal authorities, who must approve further wide-scale
If that passes, the researchers move to Phase two. Phase two involves students
that test for efficacy. It involves several hundred patients.
Phase three can involve several thousand patients. It tests for longer-term
efficiency and safety.
Phase four trials explore side effects in large number of subjects after
the drug comes to market. These are critically important for patients and
clinicians to look at rare, but important, adverse events.
It can take more than 10 years to develop a drug from start to finish
-- at a cost of hundreds of millions of dollars.
Clinical research physicians can work in labs or office settings. They
write reports outlining their findings and recommendations. They often have
a range of responsibilities, including teaching and patient care, in addition
to their research projects.
"It can be difficult to balance the many demands," says Dr. Tiffany Moore
Simas. She's a clinical research physician in Worcester, Massachusetts.
"If there is a patient sitting in front of you with a problem that needs
your attention, this always wins out over the paper or grant that needs to
be written," says Moore Simas.
"However, the writing must happen. It is essential to send out both manuscripts
and grant applications."