Clinical trials test the benefits of experimental treatments, new medications, combinations of existing drugs, and new ways of using known therapies. These tests use the most advanced drug therapies available. If a trial proves successful, the treatment may become a standard practice.
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
An experimental drug or treatment is tested on a small group of people for the first time to evaluate its safety, how it should be administered (orally, intravenously or by injection) and how often. These trials also help healthcare professionals determine a safe dosage range and identify side effects.
If the first phase is successful, the experimental drug or treatment is then given to a larger group of people to provide preliminary information about how well the new drug works and to generate more information about its safety and benefits.
The experimental drug or treatment is given to even larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly-used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Continued evaluation takes place after FDA approval, when the drug is already on the market and available for general use.
Each protocol in a clinical trial has specific characteristics, called eligibility criteria, that participants should meet to participate in the study. Characteristics may include type of disease and its stage, the participant’s age, and general health.
Eligibility criteria help assure that the study results answer the research questions at hand and identify who will benefit in the future from the approach being studied.
When considering participating in a clinical trial, it’s important to review your insurance coverage.
Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define critical trials as “experimental” or “investigational” procedures. As a result, we suggest you contact your insurance provider for more details.
In 2000, Medicare began covering beneficiaries’ patient care costs in clinical trials. Up-to-date information about what Medicare will cover can be found on the Web site of Centers for Medicare & Medicaid (formerly the Health Care Financing Administration).
Clinical Trial: The Informed Genetics Annotated Patient Registry (iGAP)
Principle investigator: Dr. Monique Gary, DO
This prospective registry will evaluate the clinical effectiveness of Germline Genetic, Genomic, and other Biomarker testing results over time in different clinical populations, in order to shape guidelines for testing, patient management, and precision therapy.
The iGAP Registry is a multi-center ongoing database designed to capture information on disease risk assessment, Germline Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment practices and outcomes to help determine, over time, the most effective use of testing in varied patient populations and to support the increased use of precision medicine.