What Is Clinical Research Studies?
Clinical research studies test the effectiveness, safety, and side effects of an investigational medicine(s) or an investigational device. These research studies are conducted on a group of volunteers. The volunteers participating in a clinical research study are essential in the development of new drugs and medical devices. Prescribed medications go through many Clinical Trials before they come available to the public. It normally takes more than 10 years researching a drug by the time it comes to market.
Drug companies sponsor studies of their products and work together with physician’s offices, medical centers or the government. Our primary concern is the patient’s safety and we are guided by the U.S. Food and Drug Administration (FDA) regulations. The FDA must approve an investigational drug for marketing before it becomes available to the public.
Who can be in a clinical research study?
Each research study has different inclusion criteria such as medical condition, age, sex and past medical history. It is important that all kinds of people are involved in a research study because each person may respond differently to medicines and other treatments. This is the reason we need men and women of different races and ages to volunteer for these research studies.
Why should I volunteer to participate in a clinical research study?
There are possible benefits from participating in a research study.
- You may have the opportunity to help yourself and others by contributing to the development of medical treatments.
- All study medication and medical visits related to the study are provided at no charge. This may include physical examinations, laboratory tests, and EKG’s.
- Your health will be monitored from an experienced study staff and as a result learn more about your disease and how best to treat it.
- You learn about the latest research and treatments for you and your family
- You receive monetary compensation for your time and travel if you qualify for the research study
There is a possibility that you may be in a study that have a “placebo” It is a “dummy” that does not contain active medication and is used to determine a possible treatment effect. Patients are selected at random to be on placebo or active drug. Neither the patient nor the medical staff can select or predict which patient gets active study drug or placebo. This is called a “double blinded” study.
How long will the study last?
Studies can last from 2 weeks to 1 or more years. Asthma studies typically last 3 to 6 months and allergy studies may last approximately 3-4 weeks.
You will be given an informed consent to read before any procedures for the research study is performed. This consent will explain why the study is being done and what you can expect. It will also explain the number of visits required to the office and all procedures that will be done. It will explain the possible benefits and risks for participating in the study. You will have the opportunity to ask any questions regarding the study.