Clinical trials are used by doctors and researchers to understand the value of a new treatment. A clinical trial may also be used to study a new way of:
- Preventing cancer
- Diagnosing cancer
- Managing side effects
- Improving a patient’s quality of life
When you volunteer to participate in a clinical trial, you have access to a treatment option for your cancer that is not otherwise available. You also gain the satisfaction of knowing that you are helping other patients with cancer. Almost all of today’s medical advances for preventing and treating cancer are the result of a clinical trial. WE offer clinical trials for several types of cancer. Speak with your doctor to see if any of these may be right for you. You may use this list of questions to help you start the conversation with your doctor or the clinical trial research team.
How Do Clinical Trials Work?
At some point in your cancer journey, your health care provider may talk with you about a clinical trial for which you qualify. You may also search the list of clinical trials available at UPMC on Central Pa.
If you are interested in participating in a clinical trial, then the first step is to apply. You will then be asked to go through a process called informed consent.
During the informed consent process you will be told about the clinical trial details, benefits and risks. This process helps you make an educated decision about whether or not to participate in the trial.
The decision to participate in a clinical trial does not have to be made on the spot. You may take time to think it over. You may also review the informed consent document with your family and friends.
This list of terms may help answer any questions you have when reviewing the informed consent document.
Beginning the Trial
If you decide to move forward with a clinical trial you will next go through a screening process. This occurs before you receive any treatment. The screening process helps to ensure that there are no physical or emotional concerns that would disqualify you from participation.
During the screening process, your clinical trial study team will take a detailed medical history. They may also perform tests. You should report any side effects that you have experienced from a medication or treatment to your clinical trial study team. You should also share any health issues or other concerns you have.
Clinical Trial Phases
Clinical trials can be used to look at different areas of the care process for cancer. These can include treatment, diagnostic, prevention, screening and supportive care. There are three phases that a clinical trial must go through to qualify for U. S. Food and Drug Administration review. Phase I aims to determine if a treatment is safe for people. Phase II provides more information about safety and how well a treatment works (i.e. to control or kill cancer cells). Phase III compares the study treatment to the existing standard treatment in a larger group setting to understand how well it works.
The safety of patients is the top concern of any clinical trial. This is why there are rules, regulations and review boards in place to guide the process.
The first stop for any clinical trial is the institutional review board (IRB). This board ensures that the clinical trial is ethical and that your rights are protected. A clinical trial must receive IRB approval before it can even begin.
Once a study is in progress, it is followed by a data safety monitoring board. This board ensures your safety by regularly reviewing research data. It also makes recommendations to stop, change or continue the study.
Federal regulations also help ensure safety by requiring that you receive written information on every aspect of the clinical trial.
The clinical trial study team will see you regularly throughout the clinical trial. This team is comprised of doctors, nurses and other health care professionals. The study team will monitor your health. They will also determine the safety and effectiveness of the treatment that is being tested.
Please note, you may leave a study at any time for personal or medical reasons.
UPMC understands that you may have many questions about clinical trials in Central Pa.
You may not know what is involved or how to start the conversation with your doctor. The following list of questions from the Conquer Cancer Foundation can help you get started. If you don’t see your question on this list, then write it down and share it with your doctor or the clinical trial research team. They will be happy to answer any question or concern you may have about clinical trials.
Questions to Ask your Doctor
- What clinical trials are open to me?
- What happens during a clinical trial?
- What are the benefits and risks of participating in a clinical trial?
- Will you continue to be a part of my care during the clinical trial?
- Where can I learn more about clinical trials?
Questions to Ask the Clinical Trial Research Team
- What is the purpose of this clinical trial?
- What is the clinical trial studying specifically?
- What other treatment options are available to me?
- Who or what organization is sponsoring the clinical trial?
- Who has reviewed and approved this clinical trial?
- What are my responsibilities during the clinical trial?
- What are the possible risks and benefits of participating in this clinical trial? How do they compare with the risks and benefits of the standard treatment?
- Where will the clinical trial take place? Will I need to stay in the hospital?
- Are there costs associated with my participation in this clinical trial?
There are many terms that may be used when describing the clinical trial process. We understand that you may not be familiar with all of these. The following list of terms from the Conquer Cancer Foundation can help.
- Control Group: A select group of clinical trial participants to which others are compared.
- Data Safety Monitoring Board: An independent committee of doctors, medical ethicists, statisticians, and other health professionals that monitor an ongoing trial’s research data.
- Institutional Review Board: A committee of doctors, statisticians, community advocates and others who ensure a clinical trial is safe and ethical.
- Inclusion/Exclusion Criteria: Guidelines that determine if a person is eligible or ineligible to participate in a clinical trial.
- Informed Consent: The process by which participants learn about a clinical trial, including their rights, safety measures, and what is being tested.
- Investigational Drug: A new drug used in a clinical trial.
- Placebo: An inactive drug or treatment. This is used only when there is no effective standard treatment or in addition to standard treatment.
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