A placebo is a pill or other substance that has no therapeutic effect. 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.
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.
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.
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 eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.
You can look for clinical trials at any time during your care, from first diagnosis onward. At Alinea Clinical Research, we encourage patients to consider a clinical trial from the very start of treatment if there’s one that’s right for them.
Yes. You can leave a clinical trial at any time and for any reason.
Every clinical trial 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.
Our IRB includes doctors, nurses, statisticians, community advocates, and others who make sure that each clinical trial is ethical and that your rights are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research to ensure your safety.
Once the trial is approved by the IRB, 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.
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.
Phase I Clinical Trials
The first step in testing a new treatment is called a Phase I trial. Phase I trials look at a new treatment to determine how well it works against a particular type of cancer, along with safety, best uses, dosage, and frequency of dosage.
These early tests can carry significant risks. While the treatments that are studied are sometimes effective, there is no guarantee that they will work. For these reasons, Phase I studies usually involve a small group of 20 to 80 patients.
The first few people in a Phase I study usually get a low dose of the new treatment. If there are only minor side effects, or none at all, the next few patients will get a slightly higher dose. This process continues until doctors find the dose that is most likely to work without causing severe side effects.
Phase II Clinical Trials
A Phase II trial typically studies how well a new treatment works in a group of up to 100 patients with a similar type of cancer. Patients are treated using the dose and method found to be safest and most effective in phase I studies.
Some Phase II studies randomly assign patients to one of two treatment groups. This is called randomization and it helps doctors learn which approach provides the best balance of safety and effectiveness. These groups may receive different treatments, different doses of the same drug, or the same treatment delivered in different ways.
In many Phase II randomized cancer trials, one group will receive the standard treatment while the other group receives the standard treatment plus the new treatment. Phase II trials may also look at the quality of life benefit offered by a particular treatment.
In some cases, if a drug is successful in a Phase II trial, the researchers may apply to the US Food and Drug Administration (FDA) to market it for doctors to treat the general public.
Phase III Clinical Trials
Phase III clinical trials compare new treatments with standard treatments, or compare new treatments with medical records from a group of patients who were observed in the past. In Phase III trials, researchers are commonly trying to see which approach is safer and more effective.
A Phase III trial can include hundreds to thousands of patients. Each participant is randomly assigned to receive either the new treatment or standard therapy.
In Phase III studies, doctors typically look to see whether the new treatment gives patients a longer life, a better quality of life, and fewer side effects, and also shows fewer cases of cancer returning than standard treatment.
In some cases, Phase III clinical trial can be stopped if the researchers notice that one group is doing significantly better than the other. If a drug is successful in a Phase III trial, the researchers may apply to the US Food and Drug Administration (FDA) to market it for doctors to treat the general public.
Phase IV Clinical Trials
After the FDA approves a treatment, it may be studied further in a Phase IV trial. Phase IV trials evaluate the side effects, risks, and benefits of a drug or other therapy over a long period of time and in a larger number of people than in Phase III trials. Thousands of people are involved in a Phase IV trial.