What is a clinical trial? A clinical trial is a specific research study that attempts to answer questions related to the understanding and treatment of disease processes affecting specific individuals and populations. These studies are carefully conducted to answer questions of safety and effectiveness of new treatments.
What does Research have to do with the approval of new drugs or treatments?
This process is called a clinical trial. Such trials are conducted in phases, which designate their level of risk.
- Phase I trials focus solely on the safety of a new treatment, including an evaluation of side effects. Small numbers of carefully selected patients are enrolled. Researchers are looking for a safe dosing level with the fewest side effects.
- Phase II trials study not only safety but effectiveness of a treatment at given doses. The number of patients involved is higher than Phase I, but usually under 100.
- Phase III trials compare the new agent with standard therapies. Participants are randomly assigned to a treatment by a computer, thereby avoiding any bias. A treatment does not reach Phase III unless it has shown promise at Phases I and II. At Phase III, hundreds of people across the country may be involved as subjects.
- Phase IV trials usually involve treatments that have been approved for standard use and are on the market. Phase IV trials are asking a wide variety of research questions, typically with low risk to the participant.
What is a protocol?
A protocol is an outline of the clinical trial. A specific protocol defines what topic is being researched. This document will specify the types of patients that will be involved; tests, procedures, and medications to be used; and the duration of the study. The protocol acts as a safeguard to monitor the health and well being of study participants.
What should you consider before entering a clinical trial?
You will want to understand all aspects of a research study before you agree to participate. You should understand that participation in a study is always voluntary and you may decide to stop participating after you join the study. A decision to not participate or to stop will not be held against you by anyone at Marshfield Clinic. Besides your physician, a research coordinator or research nurse will visit with you before you begin participation in order to answer any questions you may have and to obtain your signature on a Consent Form. It is the duty of the medical and research professionals to provide you with all the information you require. You may wish to ask questions in the following categories:
What is the study about?
- What is its purpose?
- Who is sponsoring the research?
- Who has reviewed this research and determined that it is worthwhile and that subjects are protected?
- How long will the study last?
- How will the information gained by this research be shared?
What are the possible risks and benefits?
- Are there other treatment options available?
- How do other treatments options compare in terms of risks and benefits with the treatment proposed in this research?
- What are short-term and long-term risks and benefits?
What are the steps involved in participation?
- How many visits are involved?
- What happens at each visit?
- Is any of the treatment painful? If so, how can this be controlled?
- How are these steps different from normal health care?
- Can I take my regular medication while I'm participating?
- Can I see my own doctor?
What about costs?
- Are extra charges involved?
- How much will my insurance cover?
- Who is available to discuss insurance issues with me?
What is informed consent?
The informed consent process is the primary means of learning about the facts of a specific clinical trial. The physician, nurse or research coordinator thoroughly reviews this document with every participant. Details in this consent process include the purpose of the study, its duration, the required procedures, all safety monitoring and names of key contact personnel. Once this document is signed and reviewed, the study protocol can be started. The Consent Form does not represent a contract, and the participant may withdraw from the clinical trial at any time.
What is a placebo?
A placebo is an inactive substance that is used in a clinical trial. This substance is compared to an active drug or device to determine the effectiveness of the treatment plan in question. Not every clinical trial contains a placebo and its use will be determined on the basis of the protocol.
Does health insurance cover the cost of being part of a research project?
This varies by insurance plan and by study. Normal health care visits and procedures are covered as usual. In many cases, research-related patient costs are covered by the study sponsor. Insurance providers may or may not cover the patient care costs associated with visits made or treatments undertaken solely for research purposes. Marshfield Clinic provides a Patient Assistance Center to help you with all financial questions and concerns.
Are there any protections for the safety of participants?
The entire process of research is carefully conducted and reviewed in accordance with strict ethical and scientific principles that are recognized nationally. Marshfield Clinic Research Foundation has an Institutional Review Board (IRB) that is made up of local citizens as well as researchers, and that is subject to federal oversight. The IRB has as its primary mission the protection of all human subjects. Every research study must be cleared through the IRB before start-up and also be reviewed annually. The IRB may stop any research that appears to be causing unexpected harm to participants. The IRB may also stop any research that shows that a new intervention is proving highly effective, so that it can be made more widely available.
Are there any risks or deterrents to taking part in research?
Because each study is different, the risks vary. In some cases, more visits to the doctor are required. Promising new drugs or procedures may be the focus of the research, and their ultimate safety and effectiveness are still being studied, including possible side effects. In addition, when participating in certain research projects, a patient may be not be able to choose the treatment approach taken. In all cases the patient is fully informed of all risks and deterrents before consenting to be a part of the research. Volunteers can discontinue participation in a study at any time.
Is there any benefit in being a part of a research project?
The major benefits of participating in research at the Clinical Research Center include access to investigational procedures, treatments, and approaches that may not be available in other settings. In addition, the results generated by a patient’s participation may yield medical information that can help others in the future.
Does the Clinical Research Center sponsor all its own research?
Research projects are funded in several ways. They can be sponsored by the Clinical Research Center, or by a government agency such as the National Institute of Health. In addition, pharmaceutical companies often seek out the Clinical Research Center for help in conducting clinical trials of new medications under highly regulated procedures that ensure patient safety. Every study is conducted under the supervision of a Marshfield Clinic physician or researcher.
Medical research seems quite worthwhile. How would I go about volunteering?
Talk to your physician about your interest. He or she can describe any research options available to you or put you in contact with other research professionals who can answer all your questions.
Protecting Study Participants
Your safety is a high priority for researchers at Marshfield Clinic. Thousands of people participate in clinical research at our 40 centers. To ensure safety and protect research participants' rights, an institutional review board (IRB) reviews all studies. This board includes physicians, researchers and others and is overseen by the U.S. Food and Drug Administration and the federal office of Human Research Protection.
Clinical trials are used to improve patient care. They are designed to compare the best practice known with another treatment or technique that could be better. The IRB regularly reviews projects and oversees patient response. Research staff monitors patients to ensure that health and safety are protected.
Marshfield Clinic protects the confidential health information of its patients, regardless of their involvement in clinical research trials. Only your health care providers and the researchers and others conducting or sponsoring the trial use your confidential health information. Even when research is published, individual information is compiled with that of other people. Identifiable personal information is not shared.