Patients, or clinical trial subjects, are the foundation for clinical research. Medical science would not advance without brave volunteers who, even with health challenges, are willing to enroll in studies to help develop future treatment options. As a “Community of Caring”, Springfield Clinic’s Clinical Research Department strives to provide the best patient-centered clinical trial experience possible to our clinical trial subjects.
Before enrolling as a clinical trial subject, it is important to be well informed and knowledgeable about clinical trials and clinical research procedures.
Clinical trials are scientific studies that seek to answer important medical questions about new investigational treatments or existing ones. All clinical trials are performed according to strict rules set by the Food and Drug Administration (FDA) and other regulatory agencies. These rules ensure everyone who volunteers as a study subject is informed thoroughly about the trial and treated with as much of a focus on safety and privacy as possible.
New therapies progress through the clinical research process in phases. Each phase designs clinical trials to answer different questions:
PHASE I: Is the new treatment safe?
Phase I clinical trials test a new treatment on a limited number of healthy people (20-80 people) to determine basic safety.
PHASE II: Is the new treatment effective against a specific health problem?
Phase II studies test the treatment on a small patient population with a specific health problem to determine effectiveness and the best clinical dose.
PHASE III: Is the new treatment effective in a large patient population? Is the new treatment better than available standard treatments?
Phase III studies test new treatments on a larger patient population to see if it works as well as available standard or current treatments. These studies generally take many years to plan, perform, analyze and complete.
PHASE IV: Is the new treatment safe, effective and affordable after it is approved and on the market?
Phase IV studies perform post-marketing surveillance and cost-benefit analyses after the new treatment is approved by the FDA.
Participating as a clinical research subject offers a potential for unique and impactful benefits:
Clinical research is planned, approved by medical professionals and performed by highly-trained staff as safely and as carefully as possible. However, many investigative treatments are not yet approved by the FDA and may have a risk of known and unknown side effects. Research staff will fully explain all known risks to potential participants before they volunteer and enroll into a clinical trial.
Clinical research is governed by the same ethical and legal codes as medical practice. Clinical research is also federally regulated with safeguards that protect research participants, their names, and their personal health information before, during and after a clinical trial. To ensure they are following all enforced regulations, researchers are thoroughly trained and follow carefully controlled protocols..
If your doctor determines you to be eligible for a clinical trial and you agree to participate, research staff (including your doctor) will discuss the study details and answer any questions you may have. You and the research staff will complete informed consent paperwork to show you were fully informed of all study aspects and that you agree to participate.
Clinical trial participants have a right to be fully informed before they enroll into a trial. The FDA requires all potential clinical trial participants to be given complete information about clinical studies before they agree to participate. This process is known as informed consent. Prior to trial enrollment, FDA regulations require research staff to inform potential clinical participants of:
Clinical trials sometimes go through changes or adjustments during investigation. If a study changes in a way that is different from an informed consent agreement, research staff will provide study participants with new informed consent paperwork to reflect those changes.
Clinical research participants enrolled in a study will be asked to follow specific treatment plans and attend regularly scheduled clinic visits. As a clinical subject, it is very important to follow specific study instructions. Participation durations will vary depending on the study and its objectives and participants may choose to leave a study at any time.
Clinical trial participants are not required to be Springfield Clinic patients. Any interested and eligible individual may participate in a clinical trial.
A list of Springfield Clinic’s current and enrolling studies, including the participating physicians, is referenced on the current trials page.
Please contact us if you are interested in participating in clinical research at Springfield Clinic or if you have additional questions about the Clinical Research Department.
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