Clinical Trials VS. Clinical Studies: Do You Know The Difference?
Clinical trials versus clinical studies; are they the same thing or different from each other?
Why, you ask? Does it matter?
Well, we always want to inform you of the latest drug, medical device, and surgical discoveries and updates. It helps to be an informed consumer.
Senior care is what we do, and we want you to be aware and on the cutting edge, as we are.
Let’s take a look at the methods physicians and scientists use to advance science and the improve your health and that of your loved ones.
Clinical Trials: What They Are.
Clinical trials are studies done on people that tests a medical device, surgical procedure, or behavioral approach.
The results will show if a new drug, a new diet or a new medical device is safe and effective. In addition, a clinical trial can also show if a new treatment is more effective with less side effects compared to the current standard treatment.
Another focus by researchers is to find disease early before serious complications set in. Indeed, scientists have found that a drug used against one illness, may be even more effective against a different, unrelated illness.
Preventing health problems is another objective of research scientists. Examples are diet and exercise modifications for senior citizens, testing for ways to boost cognitive performance, and improving environmental conditions.
For seniors living with a life-threatening health problem such as Alzheimer’s disease or diabetes, a clinical trial will evaluate how to improve quality of life. For example, the effectiveness of caregivers and support groups.
The U.S. Food and Drug Administration (FDA) is the regulating body that approves a clinical trial to begin.
In order to get this approval, researchers must first perform laboratory tests and studies in animals to determine a therapy’s safety and effectiveness. If these studies show good results, the FDA gives their approval to test it on humans.
The FDA clinical trials are divided into four phases or stages as you can see in the chart below. The critical phase for approval is Stage 3. If the drug or therapy is successful in this phase, the FDA approves it for prescriptions and clinical use. It continues to monitor its effects in Stage 4.
Clinical Trials: The Stages
- Stage 1 tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage. Here, the emphasis is on safety.
- Next, in Stage 2, the number of participants is increased (100 to 300). This phase tests the effectiveness and short term side effects. While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase can last several years.
- The Phase III trial collects more information about safety and effectiveness, studying different populations and different dosages. The number of subjects is increased to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the treatment.
- In Stage 4 the treatment receives approval from the FDA. Effectiveness and safety are still monitored in even larger and more diverse populations. Sometimes, the side effects of a drug might only become clear in larger populations over a longer time period.
Clinical Trials: What Are Clinical Studies?
Clinical studies, also referred to as observational studies, study people in normal settings.
Researchers collect information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, and questionnaires from senior citizens to assess the effects of different lifestyles on cognitive health.
Clinical studies can help identify new possibilities for clinical trials.