Clinical research plays a very important role in the medical community, particularly when it comes to evaluating subjects like new drugs, newly discovered illnesses, or evolving lifestyle practices. The methods used to conduct research usually involve one of two types of research: a clinical study or a clinical trial.
Someone who is well-versed on the matter is Dr. Hanid Audish, a clinical research doctor from Spring Valley California. Below, he compares clinical trials to clinical studies.
What is a Clinical Study?
Also known as an observational study, a clinical study involves the observation of participants in their normal environment. Dr. Hanid Audish explains that, as the study progresses, researchers compile information, group participants based on a number of variables, and then compare results over the duration of the study. For instance, data might be collected through a series of medical tests about a group of middle-aged females over the course of several years to learn more about the effects of different health or nutritional habits on heart health.
What is a Clinical Trial?
Clinical trials are used to evaluate or test a specific medical, behavioral or surgical procedure or intervention. Most often, these types of trials are used to determine new methods of treatments, as is the case with drug trials, or to determine if a new medical device is safe for use in the broad population.
A clinical trial might be used to test for the early onset of specific diseases or to uncover innovative ways to treat or prevent health problems. Clinical trials are also used to investigate new ways of improving the lives of individuals living with chronic or life-threatening illnesses, according to Dr. Hanid Audish.
Before a clinical trial can be approved by the FDA, various laboratory tests need to be conducted to determine whether or not it can be considered safe for humans.
The Various Phases of a Clinical Trial
The majority of clinical trials progress through four phases in order to determine treatment, appropriate dosage, uncover side effect and so forth. If, after the initial three phases, a new drug or treatment is determined to be safe and effective, the FDA will approve it for clinical use and will continue to monitor its effectiveness and safety.
Dr. Hanid Audish says that clinical drug trials are typically labeled based on the phase they are in. The FDA requires Phase 1, Phase 2 and Phase 3 trials to be completed in order to ascertain whether or not a drug should receive approval for use.
- Phase 1: Involves the testing of experimental drugs or treatments on a small group of participants (normally healthy individuals) to determine if it is safe and what side-effects might exist, as well as to determine dosage.
- Phase 2: Involves a larger testing group, and focuses more on the effectiveness of the treatment.
- Phase 3: Also focuses on the effectiveness and safety, but in participants of varying health and in different dosages.
- Phase 4: Occurs after FDA approval — the drug or treatment is dispersed to a much larger population, and long-term side effects are investigated.
While clinical studies and trials may appear to be the same, they do have two clearly different applications. Dr. Hanid Audish focuses on the side of clinical trials, testing new medications and techniques to improve diseases among patients.