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Michigan Center for Skin Care Research

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Frequently Asked Questions

Clinical research trials are used to test and evaluate investigational drugs and treatments. Before a new investigational drug or treatment can be considered for approval by the U.S. Food and Drug Administration (FDA), it must be shown to be both safe and effective. A carefully monitored clinical research trial is the best way to find out if a new treatment is safe, effective, or better than what is already available.

Phase I trials are the first step in testing a new drug on people. These are small studies where everybody in the study is given the same drug. Phase I trials answer questions about the best way to give the drug and how much of it can be given safely. The study staff watches carefully for harmful side effects and other possible risks.

Phase II trials are larger studies that continue to test the safety of the new drug. Phase II trials also begin to test how well the new drug works by comparing the new test drug with the standard treatment. In some cases, such as when there is no effective treatment for a condition, the new drug is compared to a placebo, that is, a treatment with no active ingredient. A placebo is sometimes called a "sugar pill."

Phase III trials are very large studies that are done if the new drug showed promise in Phase II studies. Phase III trials compare a new drug with the standard treatment to see which one is more effective. In some cases the new drug is compared to a placebo. Side effects are also studied. Phase III trials are usually randomized. Randomization is a research method that helps prevent the results of a clinical trial from being biased. Participants agree to be randomly selected, that is, assigned by chance, to one group or another in the research study.

Phase IV trials may be done after the new drug or treatment is already approved for use by the Food and Drug Administration. These studies continue to test the effects of the drug on different types of people, and to look for long-term side effects.

The doctors and researchers running a clinical trial develop a written plan detailing exactly how the trial will be

conducted. This plan is called a protocol. It explains how the trial will be run, what information will be gathered, and what researchers hope to learn. It also describes the tests used to assess how well each patient responds. To ensure patient safety, the protocol must be reviewed by the organization that sponsors the study as well as by an Institutional Review Board (IRB). In the review of the protocol, the board seeks to ensure that participants in the study will not be exposed to unreasonable or unethical risks.

When clinical trials compare an experimental product to a standard treatment, participants are divided into two groups. One group ("the drug group") receives the experimental drug and the other group (the "control group") receives the standard treatment.

In some cases, there is no standard treatment. When this is the case, the investigational drug may be compared to a placebo. A placebo is a substance that looks like the study drug, but contains no active drug. When a placebo is used, study participants are informed before they agree to take part in the study that there is a chance that they will not receive the study medication but may instead receive placebo. To prevent biased results, many trials assign participants by chance to one of these two groups. This process is known as randomization. Randomization is used to help ensure that study results are influenced only by the product being tested.

In a blinded or masked study, participants are not told which group they are in. The reason for a blinded or masked study is to avoid study bias. If people expect to do better on a study drug, they may report hopeful signs to researchers simply because they want to believe they are doing better. Similarly, physicians may also be blinded to the study drug a patient is receiving because, if they believe an experimental treatment may work better, it may influence their report of how the patient is doing. In either case, the study drug may appear to work better than it really does. To prevent this from happening, a study may be blinded or masked.

Every clinical trial attempts to answer some very specific research questions. To do this, each trial has certain requirements about your health, age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. You must meet the requirements of a particular trial to be an eligible volunteer.

Patients in clinical trials receive study-medication, tests and exams at no charge throughout the course of the study. Participants have access to new investigational treatments long before they're available to the public and receive closer monitoring than they would receive during standard treatment. Also patients in clinical trials have the unique opportunity to contribute to the advancement of medical research. Your participation in a clinical trial can affect and improve the treatment of medical conditions for generations to come.

Risks and side effects exist with almost any treatment whether it is standard care or a clinical trial. Although researchers expect certain results from each trial, the fact that a drug is still being studied makes it impossible to rule out side effects or adverse reactions. Many safeguards are in place to make clinical trials as safe as possible and protect patient rights. The progress of patients is closely monitored to detect and record any changes. Periodic reviews of test results and other statistics are carried out while the trial is underway to ensure maximum safety.

Please review our list of current and upcoming studies. If you are interested in participating in a particular trial, please contact Skin Care Research for further information and preliminary screening to see if you are eligible. If it is determined that you are an eligible candidate for the trial, a visit will be scheduled where the study coordinator will meet with you and explain the trial in detail, the procedures that need to be followed and answer any questions that may arise. This process is called informed consent and is essential before any volunteer is enrolled in any clinical trial.

This screening visit is also an opportunity for the study coordinator to obtain a full medical history from the participant. He or she may also perform a physical exam and schedule any laboratory tests that may be necessary before participation in the study can begin.

Before enrolling anyone in a clinical trial, study site staff will explain the possible risks and benefits to potential study participants, as well as the procedures to be used in the study and how their safety will be monitored. These issues are summarized in a document called an informed consent. All clinical trial participants must read, understand, and sign the consent form before beginning their participation in the study. It is important to ask the study site staff to explain any part of the form that is unclear. Informed consent is not a contract, and the participant may withdraw from the trial at any time. Should you decide to withdraw from a trial, please contact the Clinical Research Coordinator to let them know your reasons for leaving the study.

You need to take the trial seriously and be committed to completing the entire trial. The trial investigators and sponsor need you to be at appointments on time, to follow their instructions carefully, and especially to take and use any medication exactly as told. In many cases, follow-up visits must occur with certain "windows" of time. Missing a scheduled appointment may make you ineligible to continue the study. Your full cooperation and participation is needed if the investigators are to collect the information they must have for a successful study.