Why participate in a clinical trial?
Participants in clinical trials gain access to new research treatments before they are widely available. Often the process of collecting information in the study will allow your doctor to find out more about your condition and the effects it has on you. This may allow you to benefit from better treatment after completing the trial. Many patients also derive satisfaction from knowing they are aiding in an effort to help reduce the suffering of other people suffering from the same ailment.
What are the benefits and risks of participating in a clinical trial?
Benefits: Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
Risks: There are risks to clinical trials.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various governmental agencies. Individual participants’ names will remain secret and will not be mentioned in these reports.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it. The following questions might be helpful for you to discuss with the healthcare team. Some of the answers to these questions are found in the informed consent document.
What kind of preparation should a potential participant make for the meeting with the doctor?
Does a participant continue to work with a primary healthcare provider while in the trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provided extended or complete primary healthcare. Additionally, this will ensure that other medications or treatments provided by your primary doctor not conflict with the study medication.
Can a participant leave a clinical trial after it has begun?
Yes. You can leave a clinical trial at any time. When withdrawing from the trial, you should let the research team know and briefly explain your reasons for the leaving the study.
What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest way to find new treatments that will improve health problems.
What happens during a clinical trial?
Our clinical trial team includes doctors, psychologists, nurses, and study coordinators. They check your health at the beginning of the trial, give specific instructions for participating in the trial, and monitor your health carefully during the trial.
What are side effects and adverse reactions?
Side effects are any undesired effects of the study medication. These effects may include headache, nausea, skin irritation, or other physical problems.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate, which are an important aspect of medical research that helps to produce reliable results. "Inclusion criteria" are the factors that allow someone to participate in a clinical trial, while "exclusion criteria" are those that disallow someone from participating. These criteria are based on such factors as age, the type and stage of disease, previous treatment history, and other medical conditions. The criteria are used to identify appropriate participants, keep those participants safe, and ensure that researchers are able to answer the desired questions. Before joining a clinical trial, a participant must qualify for the study. Our standard practice is to have a study coordinator conduct a telephone screen with you to determine whether you meet the criteria for the study and whether the study may be a benefit to you.
What is informed consent?
Anyone entering a clinical trial in the United States is required to sign an informed consent, a form indicating that they understand what will happen to them during the study. It is a continuing process throughout the study to provide updated information for participants. To help you decide whether or not to participate, the doctor will help to explain the details of the study. Then you will be given the informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. Then you decide whether or not to sign the document. Informed consent is not a contract, but an agreement that you understand the study. You may withdraw from the trial at any time.
Who is the "Sponsor" of a trial?
The pharmaceutical company, government research institution, or other health organization that funds a clinical trial and designs its protocol.
What is a protocol?
A protocol is the plan for how to conduct the clinical trials. The plan is carefully designed to safeguard the health of the participants while answering specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
What is an IRB?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.
What is the FDA?
The Food and Drug Administration (FDA) is a government agency that monitors the manufacture, testing, effectiveness and use of drugs and medical devices. The FDA must initially approve a drug before it can be further tested on humans in our studies. When the results of the studies are completed, the FDA will then determine the effectiveness of the drug to determine whether it should be placed on the market for general public use.
What is a placebo?
A placebo is an inactive pill that has no treatment value. In clinical trials, experimental treatments are often compared with a placebo to determine the effectiveness of the treatment. In some studies, a group of participants are randomly selected to receive a placebo instead of an active medication.
What happens if I am on the placebo?
If you and the study doctor determine your condition is not improving while you are in the study, it could be because you are on the placebo. We will then provide you with other standardized treatment, which you and the study doctor determine, and discuss with you other treatment options.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists to answer different questions:
In Phase I trials, researchers test a new drug in a small group of people (20-80 for the first time to evaluate its safety, determine a safe dosage range, and identify any side effects.
- In Phase II trials, the study drug is given to a larger group of people (100-300) to determine the effectiveness and safety.
- In Phase III trials, the study drug is given to a larger group of people (1,000-3,000) to confirm its effectiveness, determine its safety, monitor side effects, and compare it to commonly used treatments.
- In Phase IV trials, post-marketing studies identify additional information including the drug’s risks, benefits, and optimal use.