Clinical Trials FAQs
In the past, clinical trials were thought of as last resort. Today, patients with common cancers often choose to receive their first treatment in a clinical trial because evidence shows that patients who participate in clinical trials often benefit more than those who do not.
Clinical trials are research studies that test new cancer drugs, treatments, diagnostic procedures and therapies on humans. Before any new medication is made available to the public, it must undergo a clinical trial. Clinical trials are strictly monitored and carefully evaluated, and test the therapy’s safety and efficacy.Your oncologist and the highly skilled physicians at Scottsdale Healthcare Research Institute will help you determine if you should participate in a clinical trial.
Before any medicine is made available to the public, it must undergo a clinical trial. Clinical research consists of four phases:
Phase I trials evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often the drug should be given, and amounts for a safe dosage. A Phase I trial usually enrolls only a small number of patients.
Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works, generally on a particular kind of cancer. In a Phase II trial, the study drug or treatment is given to larger groups of people (100-300).
Phase III clinical trials compare the results of people taking the new drug with the results of people taking standard treatment. In a Phase III trial, the study drug is given to large groups of people (1,000-3,000) to: confirm its effectiveness; monitor side effects; compare it to commonly used treatments; and collect information that will allow the drug or treatment to be used safely. The time frame for this phase usually is several years.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use.
Clinical trials are important for two reasons. First, patients who take part may be helped by the treatment they receive. Trial participants have access to the latest drugs, procedures and other types of treatment. Although there is no guarantee that a new treatment will be effective, many trial participants conclude that the possible benefits outweigh the risks. Second, clinical trials contribute to the overall knowledge and progress of the disease or condition being studied.
Whether you participate in a clinical trial or not is ultimately your choice. By discussing all of your options with your oncologist and the cancer care team at Scottsdale Healthcare Research Institute, you will be better able to make a decision that is right for your unique situation. At any given time, there are numerous current clinical trials in progress at Scottsdale Healthcare Research Institute. Ask your doctor if any of them may be right for you.
Each clinical trial has eligibility criteria, which are requirements that patients must meet before they can participate. Eligibility criteria might include information about:
- Age and gender
- Type of cancer
- Stage (extent) of the cancer
- Previous treatments that you must, or must not, have had
- Length of time since you last received treatment
- Results of certain laboratory tests
- Medicines that you are taking
- Other medical conditions
- Previous history of any other cancer
- Other conditions that are specific to each clinical trial
A placebo is a substance that looks like medicine, but is not. Cancer patients in a clinical trial always receive the best standard treatment available or a new treatment that researchers believe is as good or better. Only in specific circumstances are cancer patients given placebos in a randomized trial. If a placebo is used, researchers may give patients in the control group a placebo in combination with standard treatment to compare standard treatment alone to standard treatment with a new drug.
- As a clinical trial participant, you will:
- Be closely monitored by the study coordinator and physician.
- Have the opportunity to receive a new medication to treat your condition.
- Learn more about your disease or condition.
- Learn about the latest advances in treating your condition.
- Contribute to the advancement of medical care.
Before taking part in a clinical trial, talk with your doctor about some of the risks involved with treatment. For example:
- New drugs or treatments may not be better than the standard care with which they are being compared.
- New treatments may have side effects that are not expected, and may be worse than those of standard treatments.
- You may be required to make more frequent visits to the doctor.
It is your choice to participate in a clinical trial. Likewise, you may choose to leave a clinical trial at any time. If you plan to stop participating, let the research team know why you are leaving the study.
Before entering a cancer clinical trial, you should know as much as possible about the research study. It is important for you to feel very comfortable asking questions and the staff should answer them in a way you can understand. Some example questions you have may include:
- What are the possible immediate and long-term side effects?
- What other treatment options do I have?
- Will I have to pay anything to participate in the study?
- What are the charges likely to be?
- Is my insurance likely to cover those expenses?
You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Therefore, be sure to ask the principal investigator or research nurse specifically about what costs will be your responsibility if you decide to participate in a clinical trial.
The clinical trial sponsor (whether it is the government or a company) may pay for the experimental treatment, special testing and extra doctor visits.
Some health insurance companies will cover the costs of procedures that patients would have even if they were not in a clinical trial (routine costs that are considered “standard of care”). For Medicare patients, routine costs are covered in all Medicare-qualified clinical trials.
Clinical trials can be sponsored by government agencies, pharmaceutical companies, individual physician-investigators, health care institutions, universities, organizations that develop medical devices, doctor’s offices or community clinics.
The U.S. government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the United States must be approved and monitored by a local Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
If you have any other questions or concerns, please contact us as we will help guide you in the right direction.
For additional information about clinical trials available through Scottsdale Healthcare Research Institute, contact the Cancer Clinical Trials Coordinator at 480-323-1339 (toll free: 1-877-273-3713), or e-mail firstname.lastname@example.org.
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