Frequently Asked Questions
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 and most effective way to find new methods of preventing, diagnosing, and treating cancer.
What are the potential benefits of participating in a clinical trial?
You will have the chance to take an active role in your own healthcare.
You may gain access to new drugs and other treatments, sometimes years before they are widely available.
You will be making a valuable contribution to cancer research.
What are the possible risks of participating in a clinical trial?
A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, a hospital stay, or a more complicated treatment regimen. (Ask your doctor for information about the trial you are considering to participate in.)
The treatment might not work.
The treatment might cause serious side effects. However, you will be closely monitored for any side effects.
Sometimes a new approach helps some patients, and fails to help you.
What is a randomized Clinical Trial?
A randomized clinical trial is a study in which the participants are assigned by chance to separate groups with the goal being to compare different treatments. Neither the researchers nor the participants choose which group the patient is entered into. People are assigned by chance to either a standard treatment group (called the control group) or to an investigational treatment group or groups. These separate groups are referred to as the "arms" of the trial. In cancer clinical trials, the control group virtually always receives the current standard of care, which is often a treatment that would be a very reasonable choice for you to take if you were not participating in the clinical trial.
Why are patients randomized?
Randomization in a cancer clinical trial gives each patient an equal chance of being assigned to any of the groups. It is one method used to prevent bias in research.
What are the chances I will get a placebo?
A placebo is a pill or other substance that has no therapeutic effect. Many people think that clinical trials involve placebos, but only a small fraction of cancer clinical trials use them. If a placebo is part of the trial you’re considering, you will be fully informed of that fact ahead of time. You would only be considered for such a trial when it’s safe and medically appropriate.
A placebo in cancer treatment is most commonly used when a standard treatment is available to patients and we want to compare that standard treatment to a new treatment.
Do I have to pay to be in a clinical trial?
Patients generally do not have to pay extra out-of-pocket costs for treatments studied as part of a trial. Every trial is different, but the clinical trial’s sponsor usually pays for all research-related costs and any special testing.
Typically, the patient or his or her insurance company is asked to pay for any routine tests, treatments, or procedures that would be required as part of standard cancer treatment. Before you join a clinical trial, you will receive an informed consent document that spells out exactly what you’ll have to pay for and what you won’t.
How do I know if I’m eligible to join a clinical trial?
All clinical trials have guidelines spelling out who can participate. These are called eligibility criteria. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history, and other medical conditions.
Following these eligibility criteria helps the study team keep you safe and ensures that researchers learn the information they need.
Can I quit a clinical trial?
Yes. You can leave a clinical trial at any time and for any reason.
Are clinical trials safe?
To make sure the risks are as low as possible and are worth any potential benefits, every clinical trial must be approved by an Institutional Ethics Review Committee (IERC) and the Poisons and Pharmacy Board of Kenya (PPB)
The AKU IERC, includes doctors, nurses, statisticians, community advocates, and others who make sure that each clinical trial is ethical and that your rights are protected.
Once the trial is approved by the IERC, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study. You will know the full details of the protocol prior to joining any clinical trial.
What is informed consent?
Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.
If you want to participate, you will sign a consent form that details all of the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.
Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.
What is a Clinical Trial Phase?
Cancer clinical trials are usually conducted in a series of steps, called "phases." Each phase is designed to answer a separate research question. Phase I trials evaluate the safety of the drug or treatment. Phase II trials measure the effectiveness. Phase III trials test the new drug against the best existing treatment (often referred to as the standard of care). Phase IV trials are conducted to further evaluate new uses or long-term effects of the treatment.