complete details on clinical studies

1. Lecture 02
Clinical Studies
(phases)
KRVS Chaitanya

2. What is the meaning of clinical trials?
• Clinical trials are a type of research that studies new tests and
treatments and evaluates their effects on human health
outcomes.
• Clinical trials are carefully designed, reviewed and
completed, and need to be approved before they can start.
• People of all ages can take part in clinical trials, including
children.

4. Characteristic Phase 1 Phase II Phase III Phase IV
Study types Human
pharmacology
Therapeutics
exploration
Therapeutic
confirmatory
Therapeutic
use
Participant
number
10-100 50-500 1000-3000 Thousands
Types of
participant
Healthy Patient Patient Patient
prescribed drug
Primary
objective
Safety and
tolerability
Efficacy Confirm safety
and efficacy
ADRs
Study duration Month to 1
year
1-2 years 3-5 years No fixed
duration
Success rate 50% 30% 25-50%

5. What are the diff types of clinical trials?
The FDA has seven different types of clinical trials:
– Preventive trials
– Screening trials
– Diagnostic trials
– Treatment trials
– Genetic studies
– Quality of life studies
– Epidemiological studies

6. What is the clinical trials process?
• A clinical trial is a research study conducted in human
beings with the goal of answering specific questions about
new therapies, vaccines or diagnostic procedures, or new ways
of using known treatments.
• Clinical trials are used to determine whether new drugs,
diagnostics or treatments are both safe and effective

7. How long clinical trials take?
• Clinical trials alone take six to seven years on average to
complete.
• Before a potential treatment reaches the clinical trial stage,
scientists research ideas in what is called the discovery phase.
• This step can take from three to six years.

8. How many stages of clinical trials are there?
• There are 3 main phases of clinical trials – phases 1 to
3.
• Phase 1 trials are the earliest phase trials and phase 3
are later phase trials.
• Some trials have an earlier stage called phase 0, and
there are some phase 4 trials done after a drug has been
licensed

9. How many clinical trials are required for
drug approval?
• The FDA typically requires Phase I, II, and III trials to
be conducted to determine if the drug can be approved for
use.
• A Phase I trial 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

10. • A Phase II trial uses more people (100 to 300). While the
emphasis in Phase I is on safety, the emphasis in Phase II is on
effectiveness.
• This phase aims to obtain preliminary data on whether the
drug works in people who have a certain disease or condition.
• These trials also continue to study safety, including short-term
side effects.
• This phase can last several years.

11. • A Phase III trial gathers more information about safety and
effectiveness, studying different populations and different
dosages, using the drug in combination with other drugs.
• The number of subjects usually ranges from several hundred to
about 3,000 people.
• If the FDA agrees that the trial results are positive, it will
approve the experimental drug or device.

12. • A Phase IV trial for drugs or devices takes place after the
FDA approves their use.
• A device or drug's effectiveness and safety are monitored in
large, diverse populations.
• Sometimes, the side effects of a drug may not become clear
until more people have taken it over a longer period of time.

13. Phases in short
1. Phase 0 (Micro dosing)
2. Phase I (Healthy volunteers & safety)
3. Phase II ( Diseased volunteers & effective)
4. Phase III (Both safety & effectiveness)
5. Phase IV ( Post marketing surveillance)
6. Phase V

14. Thanq