February 2002
Clinical Trials and Tribulations:
Understanding Clinical Trials
Part One

The first question most people ask when they hear the word Clinical Trials is: What are clinical trials? Clinical trials are research studies that are carefully designed to; a) examine the effectiveness and safety of newly developed medications and b) find new uses for older medications that have already been approved by the FDA, looking at their effectiveness for other medical dilemmas. These studies are designed in phases or stages. The first trial is called a Phase I study. These are the first studies done on humans after the medication has been tested on other animals.

In Phase I: Researchers a) find out how the drug works on people b) see how safe the drug is c) try to find out what side affects it may cause d) evaluate new evidence regarding the effectiveness of the drug. The trial is moved into a Phase II type study, after the completion of Phase I research. Usually there are about 20 to 80 people in this type of study.

In Phase II: Drugs are given to individuals for the first time to possibly treat the illness or disease that the medication is being studied for. What they are looking for in this trial includes (the safe dose or amount was determined in the phase I trial a) the effectiveness of the drug on the disease or illness b) short term side effects and c) information on how the determined dosage is working on treating the illness. There are usually a couple hundred people in Phase II research. When all the information learned in phase II is understood, researchers start on Phase III studies.

Phase III: Researchers study a) longer-term information on the drug (The drugs effectiveness typically has already been shown.) b) more information on long-term side effects, especially infrequent or rare side effects and c) information is collected and studied to determine the relationship between the risks vs. the benefit of the drug. Several hundred to several thousand people can be in Phase III studies.

Phase IV studies follow, they are done on drugs and treatments that have been approved by the FDA.

Phase IV studies: a) evaluate the long-term side effects of a drug as they have appeared b) in this phase, usage of the medication in real-life conditions and usage by a lot of participants is studied c) may look at cost effectiveness of the drug, and also the individual’s quality of life while on the drug d) varying dosage can be studied at this phase too.

As you can see, more and more is learned about a drug in each phase. This means that you need to consider safety and comfort issues more in early Phase I and II trials than you do in later stage trials. When you are considering being in any trial always learn all you can about it from the researchers. Consider all the conditions of the study and if you can follow those conditions. Ask yourself if it can fit into your life. Only then can you make an educated choice to be in a study.

Understanding Clinical Trials:
Part Two

Here are some of the questions folks at BABES have been asking about. Hopefully this will not only give some answers, but also generate more conversation on clinical trials for all of us.

I have been asked many questions about the ACTU, what they do, who they are, etc. To begin with, ACTU stands for the (AIDS Clinical Trials Unit). The ACTU is part of a network of clinics that are all over the country. The ACTU is funded by the National Institute of Health. It is an organization that does research studies on treatments for all the stages of the HIV infection and for other HIV related illnesses.

What else does the ACTU do? They conduct research on three major areas of HIV. One major area of study is to find new ways to control or slow down the progression of HIV. Another is to find new ways to boost our own immune systems, to make it work harder or better. The third is to treat diseases that result from the HIV infection and help to prevent those diseases. This research is often done through clinical trials. Clinical Trials are carefully designed studies that examine the effectiveness and safety of new medicines. They also look at new ways to use old medications that have already been tested and approved, in different ways or on different diseases than they were originally designed.

Many people wonder if trials are safe to take part in. This is what the ACTU says on that subject. First, the FDA (Food and Drug Administration) reviews each trial, the FDA is a U.S government agency that enforces laws on the manufacturing, testing, and use of drugs and medical devices. The FDA must approve all drugs before they are available for use to the general public. The trial is also reviewed by our local IRB (Institutional Review Board), a board made up of regular people that review studies in order to protect the safety, rights and welfare of volunteers. All this happens before any study gets the ok to be done. Also, every person who wants to be in a study must be told of any major risks involved and of the benefits possible in the study before they sign up, this is called informed consent, Volunteers must sign a consent form detailing that they were told of these things and show that they understand what was explained to them before participating. People who volunteer for studies are carefully monitored throughout the entire time they are involved in a study. All studies offer at least the current standard of care to you while you are in the study.

I have personally found that while participating in studies, even more time and special care can be received. Please always take the time to ask the researchers any and all questions you may have about a trial or study before you decide if it is right for you. If you have questions later, ask them. You have the right to know the answers if the answer is known. Take care and keep those questions coming.

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