THE FIVE Clinical Trials – What Patients Need To Know —By Alan Franciscus

THE FIVE: Clinical Trials – What Patients Need To Know
—By Alan Franciscus

In this month’s The Five column, I will provide a simple overview of clinical trials, the pluses and minuses of participating in a clinical study and information about how to find clinical trials your area. I hope this article will help our readers who are interested in participating in a clinical trial to make an educated decision. '

1.  Phases of Clinical Trials – Clinical trials begin with pre-clinical studies conducted in test tubes or animals.  If the results are positive the drugs can move through different phases—1 through 3—and a possibly 4th phase.  A brief recap of the 4 phases is listed below
The pharmaceutical company will compile and review the phase 3 data and apply to the FDA for New Drug Application (NDA).  After a period of review and if appropriate the FDA will approve the medication for a particular patient population.  The FDA will also issue a package label
2.  Types of Studies – In clinical studies there are various types of studies including:
Listed below is some general information that should be included in an informed consent form.
4. Questions Patients Should Ask – If you are thinking of enrolling in a clinical trial, there are many questions you should ask yourself in order to make an informed choice:
Note:  Remember you can drop out of a clinical trial any time you want.

5. Next Steps

There are many questions to think about before entering into a clinical trial.  Some people would like to further the knowledge about a particular disease and treatment that will help their community.  Others may want to receive medical care and treatment.  Medical care and treatment may be particularly important for many people who do not have insurance or for those who have been denied coverage.  Still others who have been treated but have not been cured may seek treatment and care through clinical trials.  All of these reasons are valid and clinical trials are a good way to explore HCV treatment and care.  However, as with any HCV treatment you do not want to rush into any decision.  It is always good to do your research and work with your medical provider to make the best possible medical decision that is the best decision for you.

Ask your medical provider and/or gastroenterologist/hepatologist about clinical trials in your area.  Many medical hospitals also conduct clinical trials.

The best website that I have found is www.clinicaltrials.gov

Type in ‘HCV’ and away you go…

For more information:  Making sense of Hepatitis C Research and Medical Literature