Articles > Medical Issues > Clinical Trials 101: What you need to know (Part 2)

Clinical Trials 101: What you need to know (Part 2)

Published by 4Hope on 2002/12/18 (3219 reads)
Here's the script from the KEOM 88.5 Community Focus segment in December 2002. It is the second in a series on Clinical Trials and deals with what you should know about them, both pros and cons .

KEOM and ElderHope
December 2002
“Clinical Trials, Part 2”

Dr. Griffin: Recently we talked about participation in research studies and clinical trials and about how important this research can be for the elderly as well as for the rest of our society. Today, I understand that we are going to talk about some of the different types and phases of clinical trials and what our listeners need to know about participating in these studies.


Barb: That's right, Dr. Griffin - when your listeners hear about Phase II or Phase IV trials, it can sound pretty confusing or maybe even intimidating. However, these phase levels usually refer to the drug's development at that point and the extent of the testing. For example, in Phase I clinical trials, the researcher is generally testing a treatment or drug with a small group of people - maybe around 20-80 people - to look at the drug's safety and side effects. During the Phase III level, the treatment might be given to a thousand or thousands of people to test its safety, effectiveness, and its side effects. It can take many years of research before a drug receives FDA approval. Throughout all of these phases the researchers are continually looking at data that will indicate a treatment's safety and effectiveness - or not!

Dr. G: What happens when a treatment seems to be unsafe or ineffective?

Barb: Not too long ago, listeners may recall hearing in the news about the new vaccine for Alzheimer's disease. Researchers had found that vaccinating mice with a human gene mutation that they believed caused Alzheimer's disease in humans, resulted in a decrease in plaques that are indicative of Alzheimer's. However, when they used this vaccine in humans, it caused some seriously negative side effects. So, they stopped giving the vaccine to humans. Just recently, I've read that researchers are looking at a vaccine again, considering different aspects of using a vaccine for Alzheimer's disease. The point is that, throughout all the phases of a trial, researchers are documenting the side effects of a treatment - both positive and negative - and either continue with the research until a drug is found to be safe and effective and can be marketed to the general public, or the research is stopped, for the well-being of the study participants and the public.

Dr. G: So, what should our listeners know before participating in a clinical trial?

Barb: Those who are interested in participating in a research study should know as much as possible from the researcher about the study. The informed consent document will detail important information about the research program. However, it may also be helpful to write out important questions before they meet with the researcher, such as:

What is the purpose of the study and who is the sponsor?

What is already known about this drug?

How long do they anticipate that the study will continue and how long will each session be?

What are the possible risks and benefits of the study and will I receive any compensation or will I have to pay any fees?

What are my specific responsibilities throughout the study?

Some of these questions and more can be found in the website ClinicalTrials.gov.

Dr. G: That's important information, Barb. What types of studies are going on in the Dallas area and where can our listeners get more information?

Barb: There are many sites throughout the Dallas/Ft. worth area that are currently enrolling and seeking participants for many different types of studies. UT Southwestern Medical Center at Dallas is one such research facility and listeners can call their number at 214-648-3111. Specifically, various studies are going on in the Memory Clinic at UT
Southwestern, relating to Alzheimer's disease - for more information about this, call 214-648-7444. A complete listing of clinical trials throughout the Dallas area and throughout the US can be found at ClinicalTrials.gov .

Dr. G: Listeners can also contact you at ElderHope for more information. That phone number is 972-768-8553.

Tags: ethics   drug   pharmaceutical   clinical   development   testing   research   trial  

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