Clinical Research

WHAT IS CLINICAL RESEARCH?  Clinical research involves the use of a medication, device or method that is experimental. In the case of medicines, this usually involves a drug, which has not been approved by the Food and Drug Administration (FDA), to be used in the way it is being studied.

WHAT ARE THE PHASES OF CLINICAL RESEARCH?

Phase I

This phase involves giving the investigational drug to 20 to 80 normal, healthy volunteers to decide what is a safe dose and how the drug is absorbed and what happens to it in the body.  New West Physicians will not be participating in any Phase I studies.

All of the data from the phase I studies are reviewed carefully.  If the drug still shows promise, it moves on to phase II.

Phase II

During this phase, the drug is given to a relatively small number of patients with the targeted illness or condition.  Usually these studies only last a short period of time (a few weeks to a few months) and the subjects are watched very carefully to see if the drug has the effect that they thought it would on the disease or condition.  Again, all the data from phase II studies are reviewed carefully. If the drug still shows promise, it moves on to phase III.

Phase III

There are usually several different phase III studies done on a new drug, sometimes simultaneously.  One study might compare the drug to placebo (also know as "sugar pill").  Another might compare it to a standard, approved drug for the same disease or condition.  One might be a "dose ranging" study to decide things, like "does it work if taken once a day, or is twice a day better?"  Usually, phase III involves thousands of subjects across the country or across the world. 

Most of the studies at New West Physicians will fall into this category.   

New Drug Application (NDA)

When all of these studies are complete and the data are analyzed, the company prepares an NDA for the FDA.  Usually, there is so much data, that they have to hire a truck to haul it to Washington, DC.  An independent panel of experts is appointed by the FDA to review all the information.  They may ask representatives from the company to go to Washington, DC, to discuss the drug and answer questions.  The company and the FDA work together to prepare the specific wording on the label for the new drug.  This is what tells the doctor how to prescribe the medicine and what side effects to watch for.

HOW IS CLINICAL RESEARCH CONDUCTED?

The FDA code of regulations requires every study conducted to first be approved by an investigational review board (IRB).  It is the IRB's responsibility to protect the rights of human subjects.  A few of the responsibilities of the IRB are:

• Make sure the study is safe.
• Make sure the subjects are fully informed about the research and the risks.
• Make sure any advertising does not make false claims.
• Make sure all side effects are reported to the FDA.
• Stop a study if they feel it is unsafe in any way.

WHAT ARE MY RIGHTS & RESPONSIBILITIES AS A CLINICAL RESEARCH SUBJECT?

As a research subject, you have the following rights:

• The right to full information about the study and the drug being studied.
• The right to quit the study at any time without penalty
• The right to be informed of all alternatives to the investigational drug.
• The right to know of any new findings that might effect you or your willingness to continue.
• The right to privacy. You will not be identified by name.

As a research subject, you accept the following responsibilities:

• To take the medicine exactly as directed.
• To report ANY changes, symptoms or side effects you may have, even if You know it's unrelated.
• To notify the investigator of any other treatments or medications you may take, even over the counter.
• To honestly report any changes in your condition being studied.

FOR MORE INFORMATION ABOUT CURRENT CLINICAL TRIALS AT NEW WEST PHYSICIANS

You may ask your Primary Care Physician (PCP) about the research being done. You may also contact Gwen Carangi the Clinical Research Manager at 303-785-5992.

research@nwphysicians.com