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Basic introduction to clinical trials and the placebo effect. Definitions, examples and cartoons illustrating the subject. Ends with short info on informed consent.
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CLINICAL TRIALS & THE PLACEBO EFFECT
jschmied©2013
Plus Calculating Safety & EffectivenessIn Clinical Trials
WHAT ARE CLINICAL TRIALS? THEY ARE
Research studies using human volunteers answering specific health questions.
The safest and fastest way to find treatments that work in people.
Conducted using a plan, called a “protocol”. The protocol describes: types of patients, schedules of
tests, procedures, drugs, and dosages. Also length of study, and outcomes to be measured.
Each person gives Informed consent stating they know the risks. Participants agree to follow rules in protocol.
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PHASES IN A CLINICAL TRIAL
1. Test the new drug on a small group. Find out effectiveness, safety, dosage & side effects
2. Test Larger group. Double check effectiveness & safety.
3. Test Even larger group, confirm effectiveness, safety… side effects, compare effectiveness to other drugs already being used.
4. Studies done after drug released to public to get effect on different populations.
Some proposed drugs are Safe, but not Effectivejschmied©2013
CLINICAL TRIALS Control Trials => Study Subjects are
given Placebos!
Experimental Trials=> Study Subjects are given the
Experimental Medicine
CLINICAL TRIALS TEST EFFECTIVENESS & SAFETY
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Some people volunteer for
lots ofClinical trials!
PLACEBOS & THE PLACEBO EFFECTWhat is a placebo anyways?
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THE PLACEBO EFFECT
pla·ce·bo ef·fect
1. A positive effect or cure, produced by a placebo “drug” or treatment. The effect is not caused by the placebo.
The effect is solely due to the patient's belief in the treatment.
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DO DOCTORS GIVE PLACEBOS?
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WHAT IS THE PLACEBO?What Is a Placebo? anything that seems to be a "real" medical
treatment -- but isn't. It could be a pill, a shot, or some other type
of "fake" treatment. all placebos have nothing in them that can
treat a medical condition.
How Are Placebos Used? Given to study subjects in the Control Trial.
The study subjects don’t know if they are taking real medication or not!
So researchers can get the effectiveness of the trial drug.
Researchers subtract out the Placebo effect to get the effectiveness of the drug.
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PLACEBO EFFECT
PLACEBO ANYONE?
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“If I don’t think it’s going to work, will it still work?”jschmied©2013
The Opposite of the Placebo Effect is the Nocebo Effect
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CLINICAL TRIALS IN A NUTSHELL
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HOW TO CALCULATE SAFETY & EFFECTIVENESS USING CLINICAL TRIAL DATA
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INFORMED CONSENT - 2 PARTS 1. KNOW THE RISKS & 2. AGREE TO PARTICIPATE
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HOW TO CALCULATE EFFECTIVENESS USING CLINICAL TRIAL DATA
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Data Table 2 – A Clinical Trial
Same as yellow
(not cured)
Better than
yellow (cured)
Worse than
Yellow (cured w/side
effects)
Sample
size
Control Trial (Placebo) 5 33
% 1 7% 9 60% 15
Experimental Trial
(Medicine)1 7% 12 69% 2 14
% 14
Calculating Effectiveness Step One – The “Red Zone”• The red zone, is the section of the data table that records all the people that report being cured for each trial in a clinical trial. • In order to calculate the effectiveness of the medication being testedone has to subtract
ET = the % people who report being cured with the medicine
- CT = the % people who report being cured with a placebo Effectiveness
HOW TO CALCULATE EFFECTIVENESS USING CLINICAL TRIAL DATA
jschmied©2014
Do the Math and check your answer on the next slide
Data Table 2 – A Clinical Trial
Same as yellow
(not cured)
Better than
yellow (cured)
Worse than
Yellow (cured w/side effects)
Sample size
Control Trial
(Placebo)5
33% 1 7% 9
60% 15
Experimental Trial (Medicine
)
1 7% 1269% 2
14% 14
HOW TO CALCULATE EFFECTIVENESS
Data Table 2 – A Clinical Trial
Same as yellow
(not cured)
Better than
yellow (cured)
Worse than
Yellow (cured w/side effects)
Sample size
Control Trial
(Placebo)5 33
% 1 7% 9 60% 15
Experimental Trial (Medicine
)
1 7% 12 69% 2 14
% 14ET = 69% + 14% = 83% - CT = 7% + 60% =
67%Med Effectiveness = 16%
In this scenario the Placebo Effect is 67%! Thus, the drug is Not very Effective = 16%!
Step Two Do the Math!
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HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA
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Data Table 2 – A Clinical Trial
Not Cured CuredCured with
Side Effects
Sample size
Control Trial (Placebo) 5
33%
1 7% 10 60% 15
Experimental Trial
(Medicine)1 7% 12
69%
2 14% 14
Calculating Safety– The “Orange Zone”• The orange zone, is the section of the data table that records all the people that report being cured with Side Effects for the Experimental trial in a clinical trial. • In order to calculate the Safety of the medication being testedone has to subtract the Orange Zone data from 100%
100 - The % people who report being cured w/side effects in the ET = % Safety (of the medicine)
HOW TO CALCULATE SAFETY & EFFECTIVENESS USING CLINICAL TRIAL DATA
Data Table 2 – A Clinical Trial
Not Cured CuredCured
with Side Effects
Sample size
Control Trial
(Placebo)
533%
1 7% 960%
15
Experimental Trial
(Medicine)
1 7% 1269%
214%
14
Do the Math and check your answer on the next slide!
jschmied©2014
HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA
Doing the Math
Data Table 2 – A Clinical Trial
Not Cured CuredCured
with Side Effects
Sample size
Control Trial
(Placebo)
5 33% 1 7% 9 60
% 15
Experimental Trial
(Medicine)
1 7% 12 69% 2 14
% 14
100% -14% (% cured but have side effects)
86% Safe (% with no side effects)
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THATS ALL FOLKS!!!!
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