What you need to know
Let's discover together the future of medicine
Let's discover together the future of medicine
A Guide to Clinical Studies
Clinical trials, also known as clinical studies or more commonly as clinical research, are research studies with human participants or volunteers.
UNDERSTANDING THE
CLINICAL TRIALS
- Discovery
- Researchers discover new drugs through existing treatments
- Tests
- New Insights
- Technology
- Basic Research
- Researchers conduct studies to gather information.
- Potential Benefits
- The best dosage
- Side effects
- The best way to administer the drug or therapy.
- Research + Preclinical Development, FDA
- Researchers conduct studies to gather information.
- Isolating cells/tissues outside the living organism
- Test drug in a living organism
- Potential benefits
- New drug under investigation
- Best dosage application (FDA reviews)
- Problem reports (can take years)
Clinical trials are conducted in four different phases
Each phase has a specific purpose for the researchers
Phase 1
- Evaluate the safety of a new drug.
- Test the drug in a small group of people (20-80)
- Evaluate how the body handles the drug.
- Safe dosing ranges.
- Record side effects.
Phase 2
- The drug or treatment is administered to a larger group (100 to 300).
- Determine effectiveness.
- Continue to evaluate safety.
Phase 3
- This phase helps researchers gather additional information about the safety of the drug, confirm efficacy, and extend the effects in an even larger group and cohort. information so that the drug or treatment can be used safely.
- Hundreds or even thousands (300-3000) of people may receive a new drug or treatment and be followed for several years.
Phase 4
- Researchers gather additional safety information on an even larger group of people.
- Gather data on long-term effectiveness and its effect on quality of life.
- Evaluated by cost and against other similar drugs.
- It receives FDA approval and is widely marketed.
