If you are in the process of learning about clinical trials or are considering participating in one, you may be interested in getting to know more about it. Our frequently asked questions section below describes the role of a patient in clinical research. In addition, we encourage anyone with questions to call the Patient Recruitment Office at 972-562-2345.
What is a clinical trial?
Health care is always changing and advancing. Physicians and scientists are constantly developing new medications, new devices, and new diagnostic techniques. But for any of these to become available to you, they must first receive approval by the Federal Drug Administration (FDA).
Clinical trials are performed to determine the safety and effectiveness of any new medication, device or technique. There are 4 stages of clinical trials:
- First a test is done in animals.
- Next there are clinical trials conducted in a small group of healthy human volunteers.
- Then studies are conducted in larger groups of people who have the disease or condition that the treatment targets.
- Finally, once the treatment, device or technique is approved by the FDA, additional information is collected from patients being treated.
Why studies are called investigational?
The term “investigational” is used frequently in our advertisements to describe the study medications being evaluated. Investigational refers to a drug or device that is under clinical evaluation. This means it is studied in human populations but not approved for use by the general public. A research study to gain more information about an approved drug would require that drug to be called investigational while under study. It also can mean an approved drug that is being evaluated for use in a non-approved manner, like a:
- Change in dosage
- Route of administration or
Common examples of a change in indication would be:
- An antidepressant that is evaluated for its ability as an anxiety medication
- An antidepressant that is evaluated to treat hot flashes
- A vaccine for older adults that is being studied in a different age group.
Benefits of Participating in a clinical trial:
Our clinical trials depend on volunteer participation. It is through the thousands of people who have participated in our clinical trials that new medications and therapies are able to be brought to market. Clinical trials are, quite simply, a painless way in which you can support health care advancements. You will benefit in many ways as a participant:
- You may receive a careful evaluation of your personal health, including your nutritional and mental status. This evaluation is provided at no cost to you.
- You will have the opportunity to receive new therapies before they are made available to the general public.
- Often, we will compensate you for your time and travel costs.
The bottom line is that participating in a study at North Dallas Research Associates is a way you can personally contribute to the advancement of global health care.
What makes us different?
There are many local physicians who collaborate with North Dallas Research Associates. They have all been in private practice with multiple hospital affiliations. Each physician is board-certified in his or her area of therapeutic expertise.
At NDRA, our clinical study coordinators are certified and fully trained. These highly experienced professionals care about patients and education. They continually received updated training in:
- Their specific therapeutic area.
- General care.
- Information related to a specific study, and
- Regulatory guidelines.