Clinical Trial

2. What Is a Clinical Trial?
Clinical trials are research studies that test a
medical, surgical, or behavioral intervention
in people. These trials are the primary way
that researchers determine if a new form of
treatment or prevention, such as a new drug,
diet, or medical device (for example, a
pacemaker), is safe and effective in people.
Often, a clinical trial is designed to learn if a
new treatment is more effective or has less
harmful side effects than existing treatments.

3. Aims of clinical research
 Testing ways to diagnose a disease early,
sometimes before there are symptoms.
 Finding approaches to prevent a health
problem, including in people who are
healthy but at increased risk of developing a
disease.
 Improving quality of life for people living
with a life-threatening disease or chronic
health problem.
 Studying the role of caregivers or support
groups.

4. History of Clinical trial
The first reported clinical trial was conducted
by James Lind in 1747 to identify treatment
for scurvy.
James Lind was the son of an Edinburgh
merchant and became a medical apprentice
before joining the Royal Navy.

5. Cont..
His service allowed him to observe the effects
of scurvy at first hand.
In 1747, on board HMS Salisbury, James Lind
carried out one of the first controlled clinical
trials recorded in medical science.

6. Cont...
He proved oranges and lemons were a cure for
scurvy by taking 12 men suffering from
similar symptoms of scurvy, divided them into
six pairs and treated them with remedies
suggested by previous writers:

7. Cont...
 a quart of cider a day
 25 drops of elixir of vitriol, three times a
day
 half a pint of sea-water a day
 two spoonfuls of vinegar, three times a day
 two oranges and one lemon a day

8. Cont..

9. Cont..

10. Cont..

11. Types of Clinical Trials
1. Prevention trial
2. Behavioural trial
3. Diagnosic trial
4. Early-detection/screening
5. Treatment trial

12. Cont...
1. Prevention trial: focus on finding better
ways to prevent people from getting a disease
or health condition or lowering the chances
that people will get it.
Prevent trial may use medicines, vaccines and
lifestyles changes.

13. Cont..
Examples
medicine: use of antihypertensive medication
or lipid-lowering drugs may help in
prevention of cardiovascular diseases
Lifestyle changes:( e.g control in alcahol
intake and smoking may help in preventing or
lowering chances of getting chronic diseases.

14. Cont...
2. Behavioural trial: focuses on patient’s
behaviour and works on modifying it.
Behavioural trial involves encouragement for
people who are at risk for particular disease.
Behavoural can be conducted individuals
Examples: smokers to quit and diabetics to
exercise

15. Cont...
It also can be conducted community
examples: mas media and population.
Screening.
3. Diagnostic trial: evaluates or compare test
or procedures for diagnosing Particular
disease or condition.

16. Cont..
Diagnosic trial generally include people who
have signs and symptoms of disease.
Example: Cardia catheterization, if serious
heart disease is suspected.

17. Cont..
4. Screening test trial: evaluates new test for
detecting diseases or health conditions people
before they have any symptoms.
Screening trial can include;
1. Imaging test ( which produces areas inside
the body

18. Cont..
2. Laboratory test ( which include test of
blood, urine and other body fluids.
Example: measurement of cholesterol levels

19. Cont..
5. Treatment: focuses on finding ways to treat
a disease or health conditioin in people who
already have it.
Treatment trial include; test new treatment,
new combination of drugs.

20. Clinical phases
Clinical trials of drugs through several phases
to test safety, determine effectiveness, and
identify any side effects.
Each phase has a different purpose:

21. Cont..
 A Phase 1 trial tests an experimental drug
on a small group of people (around 20 to
80) to judge its safety, including any side
effects, and to test the amount (dosage).

22. Cont..
 A Phase 2 trial includes more people
(around 100 to 300) to help determine
whether a drug is effective. 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 examine safety, including short-
term side effects.

23. Cont...
 A Phase 3 trial gathers additional
information from several hundred to a few
thousand people about safety and
effectiveness, studying different populations
and different dosages, and comparing the
intervention with other drugs or treatment
approaches. If the FDA agrees that the trial
results support the intervention’s use for a
particular health condition, it will approve
the experimental drug

24. Cont..
 A Phase 4 trial takes place after the FDA
approves the drug or device. The
treatment’s effectiveness and safety are
monitored in large, diverse populations.
Sometimes, side effects may not become
clear until more people have used the drug
or device over a longer period of time.

25. Phases of Drug Development
Phase 1 Phase 2 Phase 3 Phase 4
No. of
Participants
20-80 100-300 300 to
thousands
Several
hundreds to
several
thousands
Length of
study
Purpose
Up to
several
months
Determine
safety and
dosage
Several
months to
2 years
Efficacy
and side
effects
1 years to
4 years
Efficacy
and
monitoring
of adverse
reactions
Less than
4 years
Safety and
efficay

26. Who are the Players?
 Human Subject Volunteers
 Physician Investigators
 Research Nurses
 Pharmacists
 Lab Techs
 Social Workers
 Data Managers

27. How do researchers decide which
interventions are safe to test in people?
Before a clinical trial is designed and launched,
scientists perform laboratory tests and often conduct
studies in animals to test a potential intervention’s
safety and effectiveness. If these studies show
favorable results, the U.S. Food and Drug
Administration (FDA) approves the intervention to
be tested in humans. Learn more about how
the safety of clinical trial participants is protected.

28. Informed Consent
 Learning the key facts about a trial before
deciding whether to participate.
– Research study purpose
– Risks/Benefits
– Confidentiality of records
– Medical treatment available if injury occurs
– Whom to contact for answers to questions
– Statement that participation is voluntary

29. What happens when a clinical trial or
study ends?
Once a clinical trial or study ends, the researchers
analyze the data to determine what the findings mean
and to plan the next steps. As a participant, you
should be provided information before the study
starts about how long it will last, whether you will
continue receiving the treatment after the trial ends
(if applicable), and how the results of the research
will be shared. If you have specific questions about
what will happen when the trial or study ends, ask
the research coordinator or staff.

30. Serious Adverse Events
 Events that results in any of the following:
– Death or life-threatening
– Hospitalization or prolonged hospitalization
– Persistent or significant disability/incapacity
 Events that are serious, unexpected, and
related or possibly related to participation in
the research must be reported to the
Sponsor, FDA and IRB in a timely manner.

31. Group 1
1. Abdikani omar mohamed
2. Faadumo cabdulaahi cali
3. Yaasmiin khaliif
4. Ayaanle
5. Xasan cabdi