Clinical Trials
What are clinical trials?
Clinical trials are studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe for people. These kinds of studies are needed to develop new treatments for serious diseases like cancer. All current prescribed medications and treatments offered to patients today have gone through all of the clinical trial phases, listed in the chart below, for Food and Drug Administration (FDA) approval.
A common concern patients may have when offered a clinical trial is “is it safe?” The answer is yes. Clinical trials are the final step in a long process, often occurring over many years, that begins with research in a lab. Patient safety is a top priority throughout all phases of clinical trials. In fact, some patients have reported feeling as though they had an extra layer of care and attention while participating in a trial due to the added monitoring required for the trial. While there is no way to guarantee that a patient enrolled on a clinical trial is going to obtain benefit from the trial, their participation is invaluable to the advancement of science today and in the future.
Who we are
St. Luke’s Clinical Trials Office (CTO) is comprised of research experts whose responsibilities range from study start-up, regulatory, financial and clinical roles. The clinical team is comprised of nurses, coordinators, and research associates who specialize in specific disease types. We all assume different functions but our sole focus is the same — YOU. Our goal is to provide you with access to advanced treatment options and most importantly, high quality care through clinical trials. We have various open trials for different cancer types that include treatment trials, genetics and biomarker trials, quality of life trials and registry trials.
What is involved
If there is an available clinical trial that your doctor feels may be a good option for you, you may be approached by one of our staff members at one of your appointments to see if you would be interested in participating. You will be provided with an informed consent form outlining all of the details about the clinical trial, which will be thoroughly explained to you by the research team. Your participation is voluntary and our goal is to ensure you have all of the information you need to make the best informed decision about your care. Each study has specific eligibility criteria which patients must meet in order to participate. If you are eligible, you may be enrolled through a process called randomization. Like a flip of a coin, the treatment assignment is selected randomly, to help compare the investigational treatment to the current approved treatment. Sometimes a placebo, often called a “sugar pill,” is used if there is no current approved treatment with which to compare the investigational treatment.
It is important to know that if at any time during the study you decide you would like to withdraw, you can do so without penalty.
How we can help
Our team is dedicated to providing an extra layer of support throughout your cancer treatment journey. We, assist with coordinating your care across all departments needed for the study, as well as serve as a point of contact to ensure all the needs of your care are met before, during and after your treatment. We partner with your study doctor to ensure you have the best experience possible and that you are closely monitored for any side effects. Additionally, our clinical trials services are offered across the entire St. Luke’s network to accommodate your care according to your preferred location.
- Informed consent: A document outlining all of the details about the clinical trial including, study purpose, required procedures, known risks, benefits, and alternatives. This information will be thoroughly explained to you by your doctor and the research team. Our goal is to ensure you have all of the information you need to make the best informed decision about your care.
- Arm: A group of patients will receive a specific treatment (or no treatment). Trials involving several arms, or randomized trials, treat randomly-selected groups of patients with different therapies in order to compare their medical outcomes.
- Randomization: Like a flip of a coin, the treatment assignment is selected randomly, to help compare the investigational treatment to the current approved treatment.
- Placebo/Control: Often called a “sugar pill”, is used if there is no current approved treatment to compare the investigational treatment.
Clinical trials are research studies in which people volunteer to test new drugs or devices. Doctors use clinical trials to learn whether a new treatment works and is safe for people. These kinds of studies are needed to develop new treatments and shape future practices for serious diseases like cancer. All current prescribed medications and treatments offered to patients today have gone through all of the clinical trial phases for Food and Drug Administration (FDA) approval.
Not all clinical trials involve receiving a certain type of treatment. Some trials are observational or registries that investigate for example, biomarkers, genetics, quality of life or information gathered for post-market data after treatments are FDA approved.
Your physician and assigned research coordinator will determine if you are eligible to participate. Each study has specific requirements that patients need to meet in order to safely participate in a trial. If you agree to participate, you will be asked to go through a screening process and additional testing may need to done in order to determine eligibility.
While there is no way to guarantee that a patient enrolled on a clinical trial is going to obtain benefit, participation is invaluable to the advancement of science today and in the future. Some patients have reported feeling as though they had an extra layer of support, care and attention while participating in a trial due to the added monitoring required for the trial.
Every clinical trial is designed differently and all financial responsibilities will be explained to you by the research coordinator. Some clinical trials use drugs that are already FDA approved and will be expected to be paid for by your insurance company. In most cases, all investigational drugs are paid for by the study. In addition, any extra tests and procedures that would not be normally be ordered by your doctor but are required for the study, are usually paid for by the study.
The amount of time you are expected to participate in a trial is determined by the design of the study. The duration of the study is usually broken down into phases. Patients who are receiving study intervention will be in the treatment phase. After the treatment phase is completed, patients will move into the follow up phase of the trial. The follow up period could last anywhere from 5 to 10 years as survival data is being collected. The follow up frequency is again determined by the trial but more often than not, it is the same follow up schedule used by your doctor.
A common concern patients may have when offered a clinical trial is “is it safe?” The answer is yes. Clinical trials are the final step in a long process, often occurring over many years, that begins with research in a lab. Patient safety is a top priority throughout all phases of clinical trials.
Yes. You don’t need to participate in a clinical trial to receive the standard treatment for your condition. Participation in a clinical trial is entirely voluntary and if you decide to participate, you can withdraw from the study at any time without penalty and continue to receive the standard care from your treatment team.
