We are always adding new clinical studies to Menter Dermatology Research Institute. If we currently don’t have a clinical trial for you, sign up to receive “Future Study Alert” to be informed of future studies.
About Clinical Trials
Before a new drug or treatment is approved by the U.S. Food and Drug Administration (FDA), it must be shown to be both safe and effective. This can be accomplished through clinical research trials, which are controlled trials to test and investigate study medications. There are no costs associated with participation and volunteers are typically reimbursed monetary amount for their participation. There are four different phases for a clinical research trial.
- Phase I studies assess the safety of a drug or device and usually involves fewer study volunteers than later phases. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased.
- Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug.
- Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
- Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. During phase IV studies pharmaceutical companies wish to compare the drug with current therapies, monitor long-term efficacy, and determine cost effectiveness compared to other therapies.
Who Qualifies for Clinical Trials?
Every clinical research study has a different set of inclusion and exclusion criteria to qualify for the study, all of which have been approved by an Institutional Review Board. These qualifications are based on the extent of the disease being investigated, medical history, and laboratory values. Patients may be “pre-screened” via telephone for baseline qualifications; more extensive testing is performed during a scheduled “screening visit”. Taking part in any study is voluntary. You may choose not to take part or may leave the study at any time. If you agree to take part and then decide against it, you can withdraw for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.
Clinical Trial Study Visits
- Patients typically need to allow 1-3 hours for their study visits. During these visits, the patients will be requested to fill out study questionnaires, have their vital signs taken, labs drawn, physical exam/assessments by a physician, and receive study medication.
- Subjects may decline participation and/or withdraw consent and at any time. A study termination visit will still be necessary, even though study drug will no longer be administered.
- During their final scheduled visit, the subject completes their participation in the study. This is usually an abbreviated visit to follow up on adverse events; it typically occurs a month after the final dosage of medication; however, all studies have individual requirements and time lines.