Clinical trials are studies designed to test new methods for treatment and prevention of specific conditions and related symptoms. Through clinical trials, physicians and researchers make progress toward improving the outcome and quality of life for a variety of participants. Trials may answer important questions regarding the value of newly discovered treatments. A team of experts monitors clinical trials. Patients are fully informed of all risks and benefits of treatment prior to participation and participants are monitored closely throughout the course of the study.
Treatment trials test a new drug or procedure to improve treatment.
Prevention trials test new interventions designed to prevent the occurrence of a predisposed condition in high-risk individuals.
Device trials test new medical devices which may require surgical placement.
Comparative effectiveness research is the direct comparison of existing health care interventions to determine which work best for a particular indication and which provide the greatest benefit.
Clinical trials evaluate new therapies in four sequential phasesto determine their usefulness in future clinical practice. Each study phase must prove that the drug is safe and at least as effective as standard treatment in order to move to the next sequential phase. The main phases include:
Pilot Study:A pilot study aims to gain initial information to help design the structure of a future study. These take a "first look" at a new idea, usually involve a small number of people, and are conducted over a short period of time.
Phase I: In the first phase, humans are given new drugs for the first time. The new drug is tested to establish safety, the maximum tolerated dose and the optimal schedule of administration.
Phase II: Once safety has been established, phase II trials are established to evaluate the effectiveness of treatment in the indication being studied. Side effects and optimal dosing schedules are further identified from the phase I study.
Phase III: The goal of phase III studies is to build on knowledge gained during phase I and II studies and compare the new treatment to standard established treatments. Phase III studies involve many more patients; often take years to complete but will ultimately help to improve and redefine the standard of care.
Phase IV: These studies seek to expand the current usage of an approved drug to evaluate other indications that might prove beneficial and to expand our appreciation of side effects.
Your physician may approach you with a clinical trial option for treatment if he/she thinks this option may be right for you. In order to protect patients' safety, individuals must meet very specific criteria in order to participate. The choice is voluntary and all advantages and disadvantages are discussed as part of the consent process. An individual may discontinue the trial at any time by his/her own choice or at the discretion of the treating physician.
Clinical trials assist clinicians in identifying new treatments that lead to improved survival and better quality of life for patients. Participants have access to state-of-the-art therapies that may not yet be available to the general public and participation will improve treatment options for future generations.
You will still receive the same level of excellent care from your physician even if you do not agree to participate in a clinical trial. A clinical trial should be presented to you as one option for treatment. Although your physician is participating in the clinical trial because he/she believes that the study is helpful for you, he/she will also understand if you decide not to participate and will never treat you any differently based on your decision.
Not infrequently, a clinical trial protocol is amended over the course of the study. There may be minor changes that would not affect your treatment or major changes that might change the treatment program. Also, over time, new information regarding side-effects of the medication being studied may be recognized that should be included in the informed consent. When protocol changes or important new information is found, you will be notified and asked to either sign an updated consent form or summary of changes document to acknowledge that you are aware of the updates and/or amendments. This provides documentation that you have been educated about the new knowledge or protocol changes. This does not mean that you are being entered into a new study.
You can contact your physician, or a research staff member to verify that a bill you receive is actually your responsibility. Billing requirements and procedures can be complicated in a clinical trial and you should not be responsible for research-related procedures. You or your insurance company can only be billed for costs which are considered "standard of care" (those which would be incurred whether you are on a clinical trial or not). Your study contact person can help investigate any bill that may not be your responsibility.