ACRIA was founded in 1991 to address the need for more community involvement in AIDS research. Since then, we've conducted many clinical trials of both pharmaceutical drugs and alternative treatments for HIV and its related conditions. And though research for new treatments is important, understanding the daily issues faced by people with HIV is also essential, so ACRIA has begun to do behavioral research that doesn't involve drugs.
Even though there are now 20 drugs approved to fight HIV, there is still a need for research and for community participation in that research. But joining a clinical trial can be scary because of the way research was done in the past, and because of the myths that are out there. Many people don't understand what clinical trials entail and have heard negative things about them. In my work, I speak with many people who know little about the realities of research. Here are some of the concerns I've encountered.
Let's think about research. When you have a headache, what do you take? Most people take something like Tylenol or Advil and don't even think twice about it. You simply go to the nearest drug store and buy the drug you want. But to buy that drug, it first had to be approved by the FDA (Food and Drug Administration). The FDA is a government agency that reviews data on all medications that are sold in the U.S. Without FDA approval, a drug cannot be put on the market. So, in order for Tylenol to receive FDA approval there had to be evidence showing that the drug actually did what the company claimed it did, and that it was safe to use. That evidence came from clinical trials of people (not guinea pigs) who had headaches. This is true for all over-the-counter medications and prescription medications. They all had to be tested in clinical trials in order for us to use them. Every medicine you have ever taken is available because people volunteered to be in clinical trials. If no one volunteered, we'd never know which drugs work and which ones don't.
Of course, with an experimental drug, the risks are greater. With everything we do in life there are risks. Some of us take those risks, which is an individual choice. The same decision applies to clinical trials. Making the choice to join a trial though there may be risks is something you should do only after talking to your doctor. There are times when the risks outweigh the benefits. In that case, joining the trial would not be a good choice. However, there are times when the benefits outweigh the risks. The only way to know is to ask the people running the trial a lot of questions and to make the decision that's right for you.
An important part of this monitoring involves you reporting any changes in your health, whether major or minor. This includes changes in the condition being studied and changes not connected to the condition. Basically, anything that happens to you needs to be reported. For example, if you sprained your ankle while in the trial, you would report when it happened, whether you took anything for it, whether you had to go the hospital for it, etc. All this information is available to the FDA to help them determine if the drug is safe. If the researchers feel that your safety may be in jeopardy you could be asked to leave the trial. And if there is a risk to other people in the trial, the FDA could shut it down completely.
Of course, the changes that happen to people in trials aren't always negative. You would need to report good changes as well. For example, if you were always tired and had little energy, but since starting the medication you have more energy, we'd want to know that and so would the FDA. The other sites involved in the trial are made aware of any serious changes, and this information is shared among all research staff so they can look for similar changes in their patients.
You will eventually learn about all of the side effects of your medications. The FDA requires drug companies to release this information, but you may not be aware that you have it. Every prescription drug comes with a "package insert" -- a paper folded inside with small print and a lot of information. This information is gathered from the clinical trials and lists the side effects of the medication based on the results of its trials. Since the insert lists every side effect reported in the trials -- no matter how rare -- it can be intimidating. Ask your doctor which side effects are most common, and what you can do about them, before you start the drug.
Key things to remember if you decide to join a trial:
Be sure to ask a lot of questions before you make your decision:
Participating in research can be a scary thing. But the more you know about it, the less scary it will be. Looking beyond the myths of research and learning about the reality of clinical trials will help you to make the best decision for you. Because in the end, it's your decision.
Dolores Holman is ACRIA's Clinical Trials Manager.