What is clinical research?
A clinical research study tests 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 investigation 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.
Upcoming Studies Include
We are currently looking for patients over the age of 18 that have been diagnosed with atopic dermatitis. Participants should have present persistent atopic dermatitis greater than 20% surface area and have failed previous topical medications.
We are currently looking for patients between the ages of 4 – 11 to participate in this short 6 visit study. We are looking for participants that are currently taking low-medium doses of daily asthma medications and have had 1 or more asthma exacerbations requiring steroids in the past year (10/2013 – present).
We are currently looking for participants over the age of 12 that take medium – high doses of daily asthma medication and HAVE NOT required steroids within the past month for an asthma exacerbation. We would like for these participants to have been taking their daily asthma medications for a minimum of 2 months prior to starting this study.
We are currently looking for participants over the age of 18 that take daly asthma medication, but continue to have more than 2 asthma exacerbations requiring steroids per year.
We are currently enrolling patients over the age of 18 that take low – medium doses of daily asthma medication. We would like participants that do not suffer from allergies or atopic dermatitis for this study please.
We are currently looking for participants over the age of 12 to participate in an 8 visit asthma study. We are looking for people that take daily asthma medication and have required steroids for an asthma exacerbation within the past year (10/2013 – present).