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.
"I Don't Want to Be a Guinea Pig"
This is the most common thing I hear when talking to people about our trials. But in clinical research we don't have guinea pigs -- we have patients. People are not asked to join a trial without good reason. Clinical trials are usually done to get approval for a treatment for a specific condition. The participants in a trial are people with that condition who are looking for a treatment for it. Each person in the trial has their own reason for joining: perhaps there is presently no treatment available, or the current treatment doesn't work for them, or they are looking for a better treatment, or they want to help others in the future. There are many reasons why people choose to take part in a trial. What's important is that you make that choice that's right for you.
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.
"There Are Too Many Risks"
This is another common statement I hear when recruiting for our trials. But not all drugs in clinical trials are experimental. Some trials are done on drugs that have been already approved and are on the market. The reason for these trials could be to use the drug for another condition, or to test a new dose of the medication. Some trials compare approved drugs to see which is better.
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.
"Why Join a Trial If There May Be Side Effects?"
The answer to this question goes back to the reason why trials are done. Trials are done not only to prove that the drug works but also to prove that it's safe. So if you participate in a trial you will be closely monitored by the research staff. This is necessary because we don't know how each participant will react to the treatment -- different people can have different reactions.
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.
"Will I Know What Drug I'm Taking?"
This is an important question to ask before you join a trial. In some trials -- open label
trials -- everyone knows what drug they're taking. But in many trials, neither the doctor nor the patient knows who is taking what drug until the trial is over. This is called a blinded
trial, and is done to prevent the researchers or participants from influencing the outcome of the trial. So, if you join a blinded trial, you will be taking drug A or drug B and won't know which one for perhaps six months or longer. Are you okay with that? If you're taking drug A and it doesn't work for you, can you switch to drug B? Knowing what will happen in the trial before you start is important when deciding whether or not to join.
Key things to remember if you decide to join a trial:
- You are a volunteer
Make sure it's your decision to join -- don't let anyone pressure you. And remember, you can leave the trial at any time if you or your doctor feel that's best for you.
- You have rights
As a participant in a trial you have the right to be informed about the trial. This is where informed consent comes into play. The informed consent form is a document that gives you much information about the study. It tells you who is doing the trial, the purpose of the trial, its length, the number of visits, the risks, the benefits, other alternatives available, etc. But there may be something not mentioned that you have a question about. You have a right to have those questions answered, so ask the research staff. Keep in mind that we may not always know the answer, but we will make sure to find out. When you sign the consent form you agree to join the trial, but remember: you're a volunteer, so you can always change your mind.
- You are not alone
Some people decide to participate in a trial without consulting with their doctor. This is not a good idea, since your doctor knows you better than the research staff. S/he can offer advice on whether or not the trial may help you. At ACRIA, we always encourage people to talk the trial over with their doctor, and we keep your doctor involved while you are in the trial.
Be sure to ask a lot of questions before you make your decision:
- How long is the trial? How often do I have to visit the study site and how long will each visit take?
- What else do I have to do while in the study?
- What is known about the immediate and long-term side effects of this drug?
- Are there other treatments available for my condition?
- Will the lab tests cost me anything? Will I get the results of these tests?
- Will I get any money for participating in the trial?
- Will I get the study drug once the trial is over?
- Who do I contact if I have a problem with how I am treated while in the trial?
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.