Clinical Trial Basics
What is a clinical trial?
An important research study that aims to improve the safety and effectiveness of a treatment compared to what is currently available. Trials seek to answer key scientific questions for the benefit of current and future individuals. It is voluntary to participate, and you may withdraw at any time.
Who is involved?
Your physician, your clinical research coordinator, and you.
Your physician is treating you per standard of care and at the direction of the protocol. The research coordinator plays a key role as a patient advocate, guiding you through the process. The coordinators stay with you through treatment and beyond, ensuring your safety as well as the trial requirements are met. Most importantly, you. We couldn’t do what we do without patients like you.
What is a protocol?
A document written by medical doctors who are experts in their field that see the potential to positively impact a patient population. The protocol states the goals of the trial and provides the blueprint on how the trial is conducted. For example, how much of a drug will be given, how often it must be taken, and what medical tests will be required to check on the participant’s safety or disease.
Who funds clinical trials?
Trials can be funded by the federal government and/or private industry. The protocols are conducted at sites such as the ones here.
Who benefits from clinical trials?
You.
We acknowledge that historically clinical trials have resulted in human rights violations, disproportionately affecting Black, Indigenous, and People of Color for the benefit of white individuals. We accept that it is our responsibility to rebuild the trust in every community negatively impacted by these events.
The goal of many NCI (National Cancer Institute) trials is to conduct large-scale clinical trials that represent actual patient populations so we can confidently apply results to all members of our community. Disparities in healthcare have long existed, and COVID-19 has brought much needed attention to the issue. These disparities must be addressed head on so that the best available treatments are being used for every individual regardless of background or identity.
Getting Started
Why should I participate?
Clinical trials offer cancer patients a different, and sometimes more effective treatment option. You will receive high-quality care from cancer specialists and be carefully and continually monitored by your physicians and WSCR’s research specialists.
You will receive the best available current treatment (also known as standard of care), or a new approach that early testing has shown may work better than the current treatment. Taking part means you are among the first to receive the newest treatment, procedures or prevention approaches before they are publically available.
Patients who take part in research studies may benefit themselves, as well as future patients as most of today’s standard of care treatments are the results of yesterday’s clinical trials. They are necessary to demonstrate the effectiveness of new approaches to treating a cancer, controlling side effects, or preventing the cancer altogether.
How do I participate?
Ask your doctor if there is a clinical trial available for you. Your doctor will discuss the potential benefits and risks with you. His or her insight and knowledge of your medical history and condition are the best basis for treatment selection. The ultimate decision, however, is always yours.
The patient will be asked to first read the informed consent to understand the trial more fully before making any decisions. If you need help understanding, talk to your doctor or contact the WSCR study team at 303-777-2663.
What is WSCR’s role?
We facilitate the processes by supporting the physicians enrolling a cancer patient in a clinical trial. Visit the “Our Team” link in the “About Us” tab to learn more about our staff and their roles.
Am I eligible for a clinic trial?
Each study includes guidelines for who can and cannot participate. These guidelines are called “eligibility criteria”.
Eligibility criteria may include age, sex, medical history, and current health status. Your doctor will make sure you are eligible for the study before you begin.
Your Rights & Protections
What is an informed consent?
It is a process where our coordinators explain the details of the clinical trial and are available for any questions or concerns. You will be informed of the potential risks and benefits of the research study and must give signed consent to participate.
Cancer is complicated, but it is our job to make sure you understand the process to the best of your ability. Once an individual becomes a research participant, a process begins for protecting the individual as a human subject.
How am I legally protected?
- The Common Rule
- The Nuremberg Code
- The Belmont Report
- Declaration of Helsinki
- Human Subjects Protection Training
- Institutional Review Boards (IRB)
- HIPAA
How will my information be used?
When you go on a study, you sign a document that allows us to collect medical information relevant to the trial. Your privacy is important to us. Your name and any other information that could be used to identify you is never sent to the study, only your medical information and a participant identification number.
How will my blood or tissue samples be used?
You must consent to having samples (whether it be a blood draw, tissue collection, or stool sample) taken for research purposes. Some studies require it as part of the science, but many do not have sample submission or it is optional. The informed consent must specify where the samples go and what they will be used for.
WSCR's Promise
In protecting each research participant, Western States Cancer Research NCORP (WSCR) adheres to the standards for scientific integrity recognized around the world. WSCR respects the dignity of research participants with regard to self-determination and full disclosure of information throughout the research process. We are also routinely audited to help protect you as a participant, and also protect the integrity of the data.
If you experience any type of discrimination or microagression at one of our clinics or hospitals, please reach out to your clinical research coordinator. Our coordinators are an extra advocate for you. Please visit our Implicit Bias link at the top to see what we’ve been reading and listening to to further educate ourselves on health disparities.