What is a clinical trial?
A clinical trial is a research study that uses volunteers as participants to test new therapies for a variety of medical conditions, illnesses and diseases. These studies are designed to find better treatment options for cancer and other serious conditions.
Why are clinical trials for cancer treatments important?
There is much to gain from cancer clinical trials. Researchers learn critical medical knowledge that contributes to making progress against cancer. This is used to improve the care of patients.
The only way that new cancer treatments can be tested to determine their safety and effectiveness before the public can use them is through clinical trials. The cancer therapies that are used today are based on the results of previous clinical trials.
What are the different kinds of cancer clinical trials?
There are four primary types of cancer clinical trials:
- Treatment trials test new medical procedures, treatment combinations or drugs.
- Prevention trials search for additional ways to prevent disease in one of two ways. Action studies focus on items such as lifestyle changes while agent studies involve taking a substance like drugs, minerals or vitamins.
- Screening trials look for new ways to find a health condition or disease early. Earlier detection can lead to better patient outcomes.
- Quality of life trials are designed to find ways that increase the comfort of patients and improve their quality of life.
How are cancer clinical trials undertaken?
Researchers and physicians design clinical research trials by developing an action plan or protocol. This protocol outlines what is involved in the study, how it will be undertaken and describes the necessity of each part.
For each study, there are eligibility criteria that determine who is able to participate in it. Some factors can include medical history, age, gender, current health status and type of cancer. Every physician and researcher involved in the study uses the same protocol.
What benefits can participants gain from a clinical research trial?
As a participant in a cancer clinical research trial, you can experience many benefits including:
- access to new therapies that could be less toxic, more effective and safer than those used today. These promising treatments are not yet available to the public or those patients who are not participating in the study.
- close monitoring of your health throughout the entirety of the trial.
- playing a proactive role in your care by increasing your options for treating your cancer.
- contributing to the overall body of knowledge available to cancer doctors and patients.
- expert medical advice, care and treatment throughout the trial and your treatment.
What risks could be involved while participating in a clinical trial?
When deciding if participating in a cancer clinical trial is the right decision for you, keep these possible risks in mind:
- There might be unknown risks or side effects with new treatments.
- All of the patient care costs might not be covered by your health insurance or managed care providers. If this is the case, the patient is responsible for them.
- Though the therapies are promising, they ultimately might not be better than the current treatments for cancer.
- Studies that are randomized do not allow participants to choose the treatment they receive.
How are a participant's rights protected?
Strict ethical and scientific principles govern clinical research trials. All research studies are approved by expert groups at the local and national levels before they are allowed to proceed.
The institutional review board (IRB) of the research agency involved in the trial is comprised of researchers, doctors, community leaders and other community members. The purpose of this group is to protect the participants' safety by ensuring that the protocol is fair and that the participants are informed of their rights throughout the process.
Who pays for cancer clinical trials?
A clinical trial typically generates two types of costs: research costs and patient care costs. Research costs are related to the patient's participation in the trial. While these costs are not usually covered by health insurance, they are often paid for by the sponsor of the trial. Some examples of research costs include study drugs, lab tests and imaging tests.
Patient care costs are directly related to treating the patient's cancer. This is true whether the participant is receiving standard therapy or is receiving new therapy. Often, health insurance pays for these costs though coinsurance fees and copays apply. Hospital stays, lab tests, and doctor visits are some examples of patient care costs.
Does the participant still see their primary healthcare provider?
Yes, because most clinical trials do not offer comprehensive primary care.
Is a patient required to participate in a clinical research trial?
During a clinical trial, the patient's participation is always voluntary. Before considering participation in any clinical research trial, you must learn all you can about the study. This includes the benefits of the specific research trial as well as the risks and its overall purpose.
This is part of your informed consent. Asking many questions and being certain that you understand the answers is an important part of the consideration process.
What kind of information about a study will a patient receive?
The research team at Blue Ridge Cancer Care provides you with crucial facts about the study. This information includes the study's purpose, the tests and procedures involved, possible benefits and any anticipated risks.
Additionally, the doctor, nurse or another staff member will provide you with a written consent form that fully explains the study. If you decide to participate, you'll be asked to sign this form. It's important for you to understand that even if you sign the consent form, you can stop participating in the study at any point in time.
How can a patient prepare when meeting with the research coordinator or physician?
There is a great deal of information that is involved with a clinical trial. Try to come prepared with any clinical trial questions that you, or your family members, might have. Doing so allows you to obtain the information necessary to make an informed decision.
It also might be helpful if you are able to record the discussion. You can do so by bringing your own recording device to the meeting. Another strategy you can also use is to bring a family member or friend with you to the meeting. Not only can they provide you with support, but they can also hear what the research team says to you about the study.
Can a participant leave a trial once it has started?
Yes, as a participant in a cancer research trial, your presence is always voluntary. You can stop participating at any time and for any reason. Before doing so, inform the research team about your decision and the reasons you are doing so.