Contact: Christine Gerdes RN, OCN, CCRP
The greater the number of people who participate in clinical trials, the faster emerging anticancer therapies can be brought to market. This need for new therapies is the reason Hematology Oncology Associates of the Treasure Coast has developed a Research Center dedicated to treating patients in the community where they reside. Hematology Oncology Associates of the Treasure Coast has been participating in clinical studies in this community for over 20 years. Our facility conducts approximately 5 – 10 new clinical trials each year. We have participated in Phase I – IV clinical trials, with a strong focus in the Phase II and III development phases.
If you are interested in contacting a Hematology Oncology Associates physician to learn more about our Clinical Trial program, please click here.
For more information please visit ClinicalTrials.gov. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
Frequently Asked Questions About Clinical Trials
If you are a cancer patient or someone you know is a cancer patient, you may be interested in learning more about clinical trials. The information below offers a brief overview of the clinical trial process, with a look at key questions and terms.
What are Clinical Trials?
Clinical trials, or research studies, utilize patient volunteers to help investigate different ways to treat diseases – such as cancer. Clinical trials involve the use of investigational drugs (also known as study drugs) and drug delivery methods. Each study tries to answer specific scientific questions about different ways to prevent, diagnose, and treat whatever disease it is addressing.
Why are Clinical Trials Important?
Clinical trials contribute to the overall knowledge and progress made in developing therapies for diseases, such as cancer. These research studies are conducted to determine if a study drug or delivery method is safe and effective. Patients who agree to participate may possibly benefit from the research study, while receiving the best current standard treatment as well.
Who is Eligible to Participate in a Clinical Trial?
Each study has its own guidelines for who can participate. Generally, participants are alike in key ways – such as the type and stage of cancer, age, gender and other factors.
Where do Clinical Trials Take Place?
They are underway throughout the country: in cancer centers, other major medical centers, community hospitals and clinics, physicians’ offices and veterans’ and military hospitals in numerous cities and towns around the United States.
In Phase I clinical trials, researchers test a study drug in a small group of people 20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety.
In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely.
In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.
What Happens During a Clinical Trial?
In many trials, if the patient is eligible and agrees to participate through Informed Consent, the patient is randomized (by chance, like a coin toss) to either receive the current standard treatment, or the current standard treatment and the study drug regimen. If no standard treatment is available, a trial may compare the study drug to a placebo (See ‘Are Placebos Used in Clinical Trials?’). During a trial, patients are treated and monitored by a team of health care professionals. This team will give the patient specific instructions about the trial, about more tests, and additional doctor’s visits that might be required.
Throughout the clinical trial, you come first. If there is no improvement or you experience intolerable side effects, you and your physician can decide to discontinue trial participation and resume other treatment options. Should you do so, your decision will be respected without any effect on future treatment plans.
Are Placebos Used in Clinical Trials?
Placebos (sometimes called “sugar pills”) are commonly used in prevention studies in order to determine whether an intervention is effective in preventing the disease from occurring or returning. Using a placebo is the only way to determine whether the actual intervention – and not the participant’s perception of participating – is effective. In treatment trials – that is, studies involving people who have cancer – placebos are very rarely used.
Why Do Some Cancer Patients Choose to Participate in Clinical Trials?
Some cancer patients may participate because they are hoping for a possible cure and longer life or a way to feel better. Others find that the current standard therapies are not optimal for their cancer and wish to be among the first to participate in a research study and receive an investigational drug. Whatever the reason, participation could make a difference in a patient’s future, as well as in the lives of future cancer patients.
How Do I Know If I Should Participate in a Clinical Trial?
The decision to participate in a clinical trial is one that only you can make, with the help of your physician and the people close to you. If you are interested in participating in a clinical trial, you will be informed of the clinical trial’s potential benefits and drawbacks before making your decision. If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will also be helping future cancer patients.
How Do I Learn More About a Specific Clinical Trial?
Through a process called “Informed Consent,” you will learn the key facts about a particular clinical trial before making a decision about participating. Your doctor will explain the purpose and requirements of the study, including any potential drawbacks and benefits. If you agree to take part in the trial, you will be asked to review and sign a form that outlines the study’s details prior to participating.
Our mission is to provide high quality, cost-effective healthcare to all of our patients. We treat all patients with warmth, respect, and dignity and provide care that is both necessary and appropriate.
Our physicians have extensive special training in the treatment of blood disorders and in the entire spectrum of cancer care. We provide consultation, treatment, and follow-up care to patients referred to our specialty by the primary care physicians of the Treasure Coast and surrounding communities.