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Clinical Research Physician  What They Do

Just the Facts

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dot 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 for asthma."

dot 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 is critical.

"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 and research."

dot 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."

dotResearch 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 guidelines.

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 the compound.

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 research.

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.

dot 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."

At a Glance

Treat patients and do medical research

  • Some focus on drug research
  • Be prepared to write lots of reports
  • You'll need a medical degree