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:

• Subjects may have an opportunity to access innovative treatment options that are otherwise not yet available.

• Subjects gain access to expert advice from specialized physicians.

• In many trials, subjects are compensated for travel and time during their participation in research.

• Subjects have an opportunity to contribute to medial technology and help to develop future treatment options.

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:

• The purpose of the research

• The length (time) of the study 

• The study design and which parts of the study are investigational

• Possible risks and/or discomforts resulting from the study

• Potential health benefits that may result from study participation  

• Alternative treatments to be considered instead of the investigational treatment  

• The FDA’s right to look at your study records under strict confidentiality

• Medical treatment available if you are hurt during the study, what those treatments are and who will pay for the treatments

• The person to contact if you have questions about the study and/or your rights as a clinical trial participant

• Your option to quit at any time

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.