What is a clinical trial?
A clinical trial is a research study that involves people as test subjects. It is the last step in a long process of testing that began, sometimes years ago, in a lab setting. In fact, most of the treatments available today are the results of a clinical trial. There are several types of clinical trials. These can be testing ways to treat cancer, diagnose cancer, prevent cancer, manage symptoms of cancer, or even manage side effects from cancer treatment.
Clinical trials are just one option to consider after a cancer diagnosis. Clinical trials are available for all types and stages of cancer. Clinical trials are critical in developing new techniques to prevent, detect and treat cancer. Researchers and doctors can determine if new treatments are safe and effective and if they work better than what is available currently. Taking part in a clinical trial helps improve cancer care and increases the knowledge that might one day be used for a cure.
A clinical trial usually has a doctor in charge of the study. This individual is called the principal investigator. They prepare a plan, or protocol, for the trial. The plan explains what is being done during the trial and includes information such as:
- Reason for trial
- Eligibility requirements, or who can join the trial
- How many people are needed
- Drugs that will be given, how, the dose, and how often
- Medical tests that will be done and how often
- Types of information that will be collected about the participants
Some clinical trials do not involve anything more than your information, and possible samples, being sent to the testing facility.
Who pays for clinical trials?
There are two types of costs related to clinical trials - patient care costs and research costs. Patient care costs are related to treating the cancer and include doctor visits, hospital stays, lab tests, and other diagnostic tests. These are usually covered by your health insurance. However, check with your health insurance provider about coverage.
The second type of costs, research costs, are related to taking part in the clinical trial. These are not covered by health insurance, but are normally covered by the trial's sponsor. (Check the information in the protocol for specifics.) These types of costs can include study drugs, lab tests specific for the research, and additional diagnostic testing associated with the trial.
Also, you might have additional doctor visits because of the clinical trial, this could also affect other expenses, such as transportation, gas, and/or child care.
Are clinical trials safe?
There are federal laws in place to ensure the safety and ethics of clinical trials. There are several safeguards that are followed, including informed consent, review and approval of the clinical trial protocol, and ongoing monitoring of the trial by several organizations.
What types of trials are available?
What types of trials are available?
- Phase 1 - a new drug or treatment is given to a small group of individuals to evaluate its safety, safe dosage, and possible side effects
- Phase 2 - drug or treatment is given to a larger group of individuals to tests its effectiveness and to evaluate its safety more
- Phase 3 - drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare to common treatments, and collect other information to allow the drug or treatment to be used by the public safely
- Phase 4 - drug or treatment is given after the drug has been released to the public to test the results in various population demographics and to monitor for side effects from long-term use
What questions should I ask my doctor?
Deciding to participate in a clinical trial is a decision that should be made with your doctor. If he or she suggests a trial, you should ask the following questions:
- What is the purpose of the trial?
- How long will I be involved in the trial?
- What phase of the trial is this?
- What kinds of tests and treatments are involved?
- Will I be told of the trial's results?
- Who will be in charge of my care?
- What are the possible side effects or risks of the new treatment?
- What are the benefits?
- Will I have to pay for any of the treatments or tests?
- What costs will my health insurance cover?
- How will this effect my daily life?
- Will I have to stay in the hospital during the trial? How often and how long?
- Will I have to travel long distances?
- Will I have checkups after the trial?
- What other treatment choices are available?
- How does this new treatment compare with current treatments?
- What will happen to my cancer without treatment?
Deciding to participate in a clinical trial for cancer is a personal decision and should be discussed with your doctor before making a decision.
Please see our Clinical Trials page for more information, as well as an in-depth list of questions to ask your doctor before making a decision.
Disclaimer: The information presented on the Susan Cohan Colon Cancer web site and blog is solely intended to provide you with information that will help educate you on the importance of diet, exercise and regular cancer screening in maintaining a healthy lifestyle. Adopting these habits is an individual choice and one that should only be made after consultation with your health care professional. No information provided on this Web site or otherwise offered by Susan Cohan Colon Cancer Foundation is intended to replace or in any way modify the advice of your health care professional.
3 comments:
Thanks for the information!
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