What is a clinical trial?
A clinical trial is a research study to answer a specific question about a treatment.
A clinical trial tests a question to see if one way is better than another way. Doctors prescribe treatments that are based on the results from past clinical trials.
Are clinical trials a last resort?
Many people believe that clinical trials are only a last resort. That is not so. Each clinical trial has a different design and some are only open to patients who have not had any treatment. Therefore, it is very important for patients to discuss clinical trials with their doctors from the very beginning and at each stage during the course of treatment so that patients can take advantage of every opportunity available to them.
Am I going to be a “guinea pig”?
Absolutely not! In fact, many clinical trials are designed to include the current standard of care. Patient care is not compromised when enrolled in a clinical trial. The oversight boards do not allow patients to be involved in studies without value or safety. However, it is important to understand the design of the trial- “what is being studied and what is being compared”. In fact, many people feel fortunate to be able to enroll in clinical trials to have access to new, promising drugs that the general cancer community does not have access to.
What do the “Phases” mean?
It is important for patients to understand what type of clinical trial they are being considered for. The informed consent will explain what type of clinical trial it is.
There are four types of clinical trials and they are called phase I, phase II, phase III and phase IV. The purpose of a phase I clinical trial is to study the effects of a drug in humans. However, the drug has been tested in the lab and in animals to see if the drug has promise in shrinking tumors. If it did show promise then the drug moves into phase I trials which means the first phase of testing in humans. Different drug dosages are tested and toxicities recorded.
The goals of a phase II study are to evaluate if the drug looks promising enough to go on to expensive phase III studies, to look at which types of cancer can be treated by the drug, to find out more about the side effects and to zero in on the most precise dosing schedules.
The goal of the phase III study is to show that the drug (or combination of drugs) is as good as or better than the current standard of care. These studies include a very large number of patients where tumor response, survival data and side effects are carefully evaluated for specific subgroups of patients.
The phase IV clinical trial is often conducted after a drug has been approved by the FDA where more information is needed about adverse events.
What does “informed consent” mean?
The clinical trial has an informed consent which is simply the process which explains or informs the patient about the clinical trial. It includes what is known about the drug or treatment and details out the possible side effects. It explains the patient’s rights and responsibilities. Patients will sign an “informed consent” document to state that they have received full explanation and are willing to enroll in the clinical trial.
Can I change my mind?
Yes. You are in charge of your care and you can leave the clinical trial at any time. Patients also need to know that they can leave a clinical trial without any fear that their doctor will treat them differently than if they were enrolled in the clinical trial.
Is my insurance going to cover this clinical trial?
The best advice is to check it out before you enroll. Most insurers will pay for the care associated with the clinical trial but not the study drug and some will even pay for the study drug or treatment if it is considered to be a standard of care. Most often study drugs are provided at no cost to the patient. The clinical trial may also cover the cost of doctor visits or transportation to and from the visits. Medicare does not cover the cost of the study drug. Many states mandate insurance companies to cover the cost of clinical trials. Your oncologist and/or research nurse will have a good understanding of what is covered by the trial and what is not but it is the patient and family’s job to know the answers before a patient enrolls.
Do I have go to a big hospital for clinical trials?
No. Many cancer doctors who practice in the community have a way to enroll patients into clinical trials. If a doctor does not talk to you about the option of a clinical trial, make sure to ask your doctor if there are any clinical trials that are specific to you.
Why do I need to know who’s sponsoring the clinical trial?
Clinical trials can be designed and run in many different ways. They can be designed and run by drug companies, physicians or groups of physicians. It is important to know who is behind the trial in order to understand the true value of the study. Physicians may or may not be paid based on how many patients they bring to the study. It is important to know if your physician has any bias toward a particular study and why. Bias isn’t always a bad thing, it is just very important to understand what the biases are. Be assured that the overwhelming majority of clinical trials are worthwhile and are constructed by intelligent physicians asking intelligent questions that need to be answered by a clinical trial.
How do I know if it is safe to enroll in the study?
You will receive “informed consent” prior to giving your permission to be in the study. This consent form will explain the study in great detail and notify you of all of the possible side effects. Before a clinical trial reaches the patient, it has been through a highly rigorous review board(s) to ensure patients the highest level of safety. Ask lots of questions about the potential side effects or dangers of the study and then you decide if (you were to get the side effects) would you be able to manage them or not.
Why are clinical trials so important?
Clinical trials are important to the future of cancer treatment. Doctors prescribe your treatment today based on the results of clinical trials that have been completed in the past. The cancer community owes a great debt to patients who were in clinical trials for helping to advance the treatments for cancer patients in the future.
Where can I go to find a clinical trial for me?
The Coalition of Cancer Cooperative Groups at www.CancerTrialsHelp.org
is nonprofit organization whose mission is to educate patients about clinical trials and to help them find a clinical trial in their area. The website features TrialCheck® which provides an easy way to check the most up-to-date clinical trial information available in the United States.