CONDUCTING CLINICAL research trials as a physician investigator represents a multi-faceted opportunity for practicing physicians.  It allows physicians to gain first-hand experience with novel therapies and provides patients with treatment options that may be available only in a clinical trial.  The 2001-2002 annual report of the Pharmaceutical Research and Manufacturers of America shows that U.S. pharmaceutical companies will spend more than 30
billion dollars on research and development this year.  The majority is spent on clinical trials.1 Physicians are needed by pharmaceutical sponsors (drug companies) to serve as principal investigators and conduct trials on their patients.

What is clinical research?

Pharmaceutical clinical research integrates medical practice, compliance with regulatory requirements and a research-based evaluation of drug therapy.  Clinical research is a process of conducting clinical studies overseen by an investigator. Most investigators for new drug therapies in the U.S. are physicians with active medical practices.  Clinical research is a component of the drug research and development process that occurs in sequential phases.

The drug development process

The discovery phase may encompass isolation of a potential compound from an organic source or organic chemical synthesis of a
specific new molecule.  Once identified and initially characterized, patent application typically follows. The pre-clinical research phase includes
both chemical and biological characterization, as well as assessment of teratogenic, mutagenic and carcinogenic activity in whole animal models, isolated
tissues or cell lines.  Once adequate data exist to substantiate the risk of introducing a compound into human subjects, an Investigational New Drug (IND) application is filed with the Food and Drug Administration (FDA).  Barring any concerns by the FDA, clinical research commences.  Clinical research occurs in sequential phases (I, II and III) each of which occurs before submitting an NDA for marketing approval.

Source and for more information, Research Provides Golden Opportunity for Physicians; Ruth Ann Nylen, PhD