FAQs

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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• 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.

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