Introduction
The process that brings a new drug from the research laboratory to the marketplace is a long and careful one. Long, because it takes years to complete all the laboratory tests; careful, because all those involved in bringing it to market must follow strict government regulations regarding the drug's safety and how well it works.
One of the most important steps in the development process is the clinical trial, which is a study with people like you who volunteer to receive the drug and be observed for it effects. It is through these trials that important new drugs can show their benefits in human beings. But before this can happen, people must volunteer and participate - a choice that may benefit not only the individual but many, many others as well.
Whether or not a clinical trial is right for you depends on a number of factors, including your medical condition. Your physician will discuss these factors with you and provide all of the information available on the drug and the trial itself.
Still, you may have questions. You should. Participation in a clinical trial can be a great undertaking, and there are no guarantees that the drug will work. This page, however, will help you understand the benefits and risks of participation, and give you some idea of what to expect if you decide to participate.
What is a Clinical Trial?
A clinical trial is carefully supervised research that is done in humans prior to the release of a drug to the general public.
The term clinical refers to research performed in a hospital or clinic setting in which a physician and other health care professionals observe a patient. A trial is a study, whereby the drug is analyzed for its effects on a group of patients.
However, before a drug enters the clinical trial phase, it is extensively tested through basic or preclinical research in the laboratory, both in lab experiments and in animals. The type of experiments depends on the disease being studied, and if animals can also have the same disease. This type of research is extremely important in gathering information on the drug's possible benefits and limits before it is tested in humans.
It is important to understand that both basic research and research done through clinical trials are carefully supervised, monitored and documented. New drugs must prove themselves beyond doubt before they take their place on the pharmacy shelf. Clinical trial volunteers play a very big role in this process.
Why Do People Become Involved in Clinical Trials?
The reasons why people become involved in clinical trials are as varied as the individuals themselves.
Some people have an illness, which currently has no treatment. A clinical trial may offer the opportunity to try a medication, which may help.
Some may become involved because their current medication has too many side effects and they want to see if they can tolerate the drug being tested.
Others may want more interaction with health care providers to discuss their medical condition.
And others volunteer because they want to help find answers to scientific or medical questions that will help others benefit in the future.
Only you can decide whether or not a clinical trial is right for you. That's why you should take plenty of time to think about the trial and ask all the questions you want. You may even consider asking a close friend or family member to help you in your decision - they may have questions or concerns that you may not have considered.
Above all, remember that there are risks associated with clinical trials. And yes, it's a tough decision. Have all the facts before you make up your mind.
What are the Risks Involved in Clinical Trials?
Drugs are tested in clinical trials because not everything is yet known about them. So there may be drawbacks to treatment, which will not be uncovered until after treatment begins. Your physician will discuss these potential risks with you. You must carefully weigh them against the possible benefits, and ask as many questions as you need to. Keep the following in mind when evaluating risks.
Sometimes the risks, or side effects, may be no worse than those of your current treatment options. Other times, the side effects may seem greater.
You may react differently from another patient when given the same drug. Preclinical testing in the laboratory can often give scientists and physicians an idea of what patients may experience in the clinical setting. But every patient is different. Your physician will ask you a lot of questions ahead of time to learn as much as possible about your medical history in order to reduce the potential risks.
In addition, the risks associated with clinical trials can vary depending upon the disease being treated. These risks are carefully weighed and balanced by your physician, the study physician, the Food and Drug Administration (FDA), and an Institutional Review Board (IRB). An IRB is a group of doctors, scientists, patient advocates, legal representatives and clergy which reviews a clinical study for safety issues.
If something shows up that is a threat to patients in the clinical trial, the patients will be notified by the investigator and the trial may be stopped or placed on hold until more information is known.
What is a Placebo?
A placebo is a harmless, inactive product used to compare results of the active drug or treatment being studied and to learn more about its actions. It is used in clinical trials as one of many possible treatments. Because the patient and health care professionals usually do not know which individual has received the placebo and which has not, observations in the clinical trial can be conducted more fairly, since undue concentration of the people who received the new drug is reduced.
What are the Benefits of Participating in a Clinical Trial?
There are a number of potential benefits from participating in a clinical trial. In general, they include:
The opportunity to become involved in the testing of a new drug that would not otherwise be available.
Free study medication and special medical care during the clinical trial.
Close contact with your health care team for better evaluation of your disease course.
Contributing to medical science which may help other patients now and in the future.
Where are Clinical Trials Performed?
Clinical trials can occur in a variety of places. Some are performed in a hospital and others right in the doctor's office. Still others are done in special research centers.
If you decide to participate in a clinical trial, you will receive information regarding the treatment location. In some cases, provisions may even be made for family members if the trial is to be conducted away from home.
Are Volunteers Required to Pay for Participation in Clinical Trials?
No. You should not be asked to pay to be in a clinical trial. In most cases, study medication is provided free of charge.
In addition, the costs of many tests and procedures associated with the trial will not be charged to you. And in most instances, the cost of routine tests and procedures that are part of your normal health care will be paid per the terms of your current insurance plan.
If you are considering participation in a clinical trial, discuss the financial implications with your physician or other health care professional. They can tell you exactly what will be covered as part of the clinical trial and what will be considered part of your normal health care routine. Remember to ask everything that's on your mind. It's your right.
How Do People Become Involved in a Clinical Trial?
People interested in clinical trial participation should discuss this option with their physician. It's the best way to learn whether or not an appropriate trial is available, and where it is being conducted. Patients are screened to determine if they are right for a given trial. Sometimes screening involves nothing more than a series of questions and answers. Other times it may require laboratory tests. In any case, these tests are performed only with the patient's consent.
Not every disease will have a clinical trial currently underway. But this situation is constantly changing. Consult your physician or patient support group to learn if research is being planned which may be appropriate for you.
"I found an article on the bulletin board at the hospital...and they were anxious to have people who were interested in trying to get involved with the program" - Alfred, Clinical Trial Volunteer
What are the Participant's Responsibilities?
Your responsibilities will be explained to you by your health care team. In general, however, you must see your physician as scheduled and take your medication as prescribed.
You may also be asked to keep a diary of your experience with treatment; this may help give your physician information on the safety and effectiveness of the treatment. You should also contact your physician as soon as possible if you are hospitalized for any reason.
In addition, it is important to let all of your non-study physicians know that you are participating in a clinical trial. They will need the name and phone number of the study physician in order to let him or her know about any pertinent medical information which may affect your treatment in the trial. You may also consider keeping the study physician's name and number with you at all times in case of emergency.
Can People be Enrolled in a Clinical Trial Without Their Knowledge?
No. Clinical research is heavily regulated by the federal government and by the medical profession. You are protected from unauthorized research without your consent through informed consent.
Informed consent means that your physician and/or study nurse will thoroughly explain the clinical trial to you and may provide a package of information on the trial along with an informed consent form. The informed consent form provides information on the length of the study, potential side effects (if known) from the drug being tested, your rights to withdraw from the study, and how the study is considered completed.
The consent form will also explain how the study protocol is designed, whether or not a placebo is to be used, and what kind of tests will be required. At the end of this page you will find a glossary of terms that may be used in the informed consent form. If you don't understand any of the terms, it is important that you ask your physician or nurse.
Once you are satisfied that you have a full understanding of the nature and scope of the trial and decide to proceed, you may sign the informed consent form. However, remember that you always have the right to say no. If you are uncomfortable with what you are being asked to do in the study, or if you don't fully understand it, or if you simply don't want to participate any longer, do not feel like you have to participate. Although you can withdraw from a study at any time, it is better for all concerned if you refuse participation before beginning if you are unsure of your ability to complete your commitment.
