We appreciate your possible interest to be a volunteer in a clinical trial. We realize you, your family, or significant other may have questions about what a clinical trial is and what is involved if you agree to join. The following is general information of what a clinical trial is and may answer many of your questions.
What is a clinical trial?
Drugs, vaccines, some items made from human blood, and medical devices like hearth pacemakers or artificial joints are thoroughly studies before being allowed for use by doctors for their patients. While these products are being studied and before being approved, they are considered “investigational products”. There are many research studies (“trials”) that must be done on an investigational product to see if it is safe and if it works or is effective.
How does the trial work?
Every study follows a specific written plan or “protocol”. The protocol explains how the trial is to be done. The protocol describes the goal of the study, how many volunteers are needed, the types of tests required, how many study visits a volunteer makes, and what information is collected by the doctor and his staff from the study volunteers. Once the protocol is done for all of the volunteers, all of the information is put into a report and sent to a government agency like the Food and Drug Administracion (FDA) in the USA or Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. These agencies review the results and decide if the investigational product should be approved to treat people.
How is my safety monitored?
There are country and international guidelines and laws that study doctors and drugs companies must follow for every clinical trial they do. Every country has a national government agency (like the FDA and MHRA mentioned above) who oversee clinical trials activities.
Additionally, the protocol must be reviewed and approved by an Institutional Review Board, Ethics Committee and sometimes other local or country groups. These groups must give approval for a research doctor to begin the study. Their main concern is the safety of the volunteers.
Some protocols also have a further independent safety monitoring committe. The safety committe reviews information at regular intervals during the study to look out for potential safety issues. Lastly, your study doctor and his team will see you during your regular visits. They will assess how you are doing and if you are having any problems. You will have a person at the study site to contact should you have any problems between visits.
Why should I sign up for a Clinical Trial?
The purpose of a clinical trial is to see if the investigational product is safe for use in people in general, safe for people with the disease it will treat, and if it works. Volunteers are needed to complete the testing. Participation in a clinical trial helps researchers potentially find a treatment for a new or existing disease, or to improve on treatments already available.
What are the risks and benefits associated with your participation in a clinical trial?
Each clinical trial has its own benefits and risks, depending on the type of trial and what it’s trying to figure out. Still, there are some potential benefits and risks that are common to most clinical trials.
♠ Access to a treatment that isn’t available yet. This treatment may be more effective or have fewer side effects than the treatments that are currently available.
♠ Regular and careful attention from some of the best doctors. The research team that conducts clinical trials usually includes top doctors and scientists from around the United States and the world, all of whom will be working together with you. Because of this close monitoring, any side effects you might have are noticed and dealt with immediately.
♠ Treatment that may be free or low cost. Some clinical trials may pay for part or all of your treatment, other medical care, travel, and other expenses during the study. But not all clinical trials do this. Make sure you know exactly what you’ll have to pay for BEFORE you agree to be part of a clinical trial.
♠ Contributing to research that may save lives in the future. The treatments we have today are available because large numbers of patients opted to participate in clinical trials to test them.
♠ The feeling that you’re taking an active role in your care. Deciding to participate in a clinical trial can make some people feel as if they have more control over their situation, which can lead to a more positive outlook and better quality of life.
♠ Not being able to choose which treatment you get. In randomized trials, you are randomly assigned to get a specific treatment. In some trials, you may be assigned to get a placebo (sugar pill). In a randomized, double-blinded trial, neither you nor your doctors know which treatment you’re getting (but if the information is needed, it’s available).
♠ The new treatment may not work for you, even if it benefits other people in the trial. It also may turn out that the new treatment isn’t as effective as what’s currently available.
♠ More severe side effects than current treatments. This is more likely to happen with Phase I or Phase II trials.
♠ More frequent testing and doctor visits. Because you’ll be closely monitored, you may have to undergo testing more often than you would if you weren’t in the trial. This could mean more travel and time in the doctor’s office or hospital for you.
What is Informed Consent?
IT is your right to receive information about the trial and to have as much time as you need to consider this information before you agree to take part. All of this information will be in a written document called a consent form. The study doctor of his staff will explain the study to you and give you this document to review. They will tell you about the investigational product, risks, how to use the investigational product, how long you will be in the study, how often your study visits are, and the different tests and examinations that will be done. They will explain your rights as a volunteer in the study. You will be told what to do and who to contact if you have any problems during the study.
After discussing the study you will have the opportunity to ask the study staff any questions you may have. You should read and undestand all of the information in the study consent form and have all of your questions answered before agreeing to participate in the trial. Once your questions are answered and you decide to participate in the study, you will sign the consent form. The study staff will also sign to confirm they have explained the study to you. You will be given a copy of the signed consent to take with you. Informed consent means the study has been explained to you, all your questions have been answered, and you have given your consent (permission) freely. No study procedure can be completed until you sign the informed consent.
What is a Placebo?
Some studies are designed to determine if the investigational product is as good if not better than another product. Other studies test if it is better than receiving no treatment at all. In these studies volunteers who are not receiving the investigational product are given a placebo.
Placebo is made of inactive substances so has no effect on you. It is also designed to look the same and be packaged the same as the investigational product. You may be assigned to the investigational drug, the approved drug or to the placebo. Neither you nor your research doctor knows if you are getting the investigational product or placebo.
This avoids volunteers and researchers from showing a preference for one of the drugs in the study while collecting study information.
What can I expect during the Trial?
Your research doctor and his/her staff will determine if you meet the entry requirements for the study. Remember the study protocol includes detailed information of who can and cannot enter the study. The staff will ask if you are interested in the study. If you are, they will explain the study to you and answer all of your questions. It is important that you determine if you are able to make the return visits, take the investigational drug as ordered and follow any other study directions. If you are still interested you will then be given a study consent to read and sign. A copy of the completed consent will be given to you. Any tests or procedure required by the study will only be performed once you have read and signed the study consent. You will then make return visits to the research staff so they can evaluate your health and progress in the study. Once you have completed the study you are free to discuss other treatment options with your doctor.
WE HOPE THIS INFORMATION IS HELPFUL TO YOU. IF YOU HAVE ANY OTHER QUESTIONS FEEL FREE TO CONTACT US