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CLINICAL TRIALS & THE PLACEBO EFFECT 
Plus Calculating Safety 
& Effectiveness 
In Clinical Trials 
jschmied©2013
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. 
jschmied©2013
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 Effective 
jschmied©2013
CLINICAL TRIALS 
Control Trials => Study Subjects are given 
Placebos! 
Experimental Trials=> Study Subjects are given 
the 
Experimental Medicine
CLINICAL TRIALS TEST EFFECTIVENESS & SAFETY 
Some people 
volunteer for 
lots of 
Clinical trials! 
jschmied©2013
PLACEBOS & THE PLACEBO EFFECT 
What is a placebo anyways? 
jschmied©2013
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. 
jschmied©2014
DO DOCTORS GIVE PLACEBOS? 
jschmied©2013
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. 
jschmied©2013
PLACEBO EFFECT
PLACEBO ANYONE? 
jschmied©2013
“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 
jschmied©2013
CLINICAL TRIALS IN A NUTSHELL 
jschmied©2013
HOW TO CALCULATE SAFETY & EFFECTIVENESS 
USING CLINICAL TRIAL DATA 
jschmied©2013
INFORMED CONSENT - 2 PARTS 
1. KNOW THE RISKS & 2. AGREE TO PARTICIPATE 
jschmied©2014
HOW TO CALCULATE EFFECTIVENESS 
USING CLINICAL TRIAL DATA 
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 tested 
one has to subtract 
ET = the % people who report being cured with the medicine 
- CT = the % people who report being cured with a placebo 
Effectiveness 
jschmied©2014 
Data Table 2 – A Clinical Trial 
Same as 
yellow 
(not cured) 
Better than 
yellow 
(cured) 
Worse than 
Yellow (cured 
w/side effects) 
Sampl 
e size 
Control Trial 
(Placebo) 5 33% 1 7% 9 60% 15 
Experimental 
Trial 
(Medicine) 
1 7% 12 69% 2 14% 14
HOW TO CALCULATE EFFECTIVENESS 
USING CLINICAL TRIAL DATA 
Do the Math and check your answer on the next slide 
jschmied©2014 
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 
Experiment 
al Trial 
(Medicine) 
1 7% 12 69% 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 
Experiment 
al Trial 
(Medicine) 
1 7% 12 69% 2 14% 14 
ET = 69% + 14% = 83% 
- CT = 7% + 60% = 67% 
Med Effectiveness = 16% 
Step Two 
Do the Math! 
In this scenario the Placebo Effect is 67%! 
Thus, the drug is Not very Effective = 16%! 
jschmied©2014
HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA 
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 tested 
one has to subtract the Orange Zone data from 100% 
100 - The % people who report being cured w/side effects in the ET 
jschmied©2014 
= % Safety (of the medicine) 
Data Table 2 – A Clinical Trial 
Not Cured Cured 
Cured 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
HOW TO CALCULATE SAFETY & EFFECTIVENESS 
USING CLINICAL TRIAL DATA 
Data Table 2 – A Clinical Trial 
Not Cured Cured 
Cured with 
Side 
Effects 
Sample 
size 
Control 
Trial 
(Placebo) 
5 
33 
% 
1 7% 9 60% 15 
Experime 
ntal Trial 
(Medicine) 
1 7% 12 69% 2 14% 14 
Do the Math and check your answer on the next slide! 
jschmied©2014
HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA 
Data Table 2 – A Clinical Trial 
Not Cured Cured 
Doing the Math 
Cured with 
Side Effects 
Sample 
size 
Control 
Trial 
(Placebo) 
5 
33 
% 
1 7% 9 60% 15 
Experimen 
tal Trial 
(Medicine) 
1 7% 12 69% 2 14% 14 
100% 
-14% (% cured but have side effects) 
86% Safe (% with no side effects) 
jschmied©2014
THATS ALL FOLKS!!!! 
jschmied©2014

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Clinical trials placebo effect

  • 1. CLINICAL TRIALS & THE PLACEBO EFFECT Plus Calculating Safety & Effectiveness In Clinical Trials jschmied©2013
  • 2. 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. jschmied©2013
  • 3. 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 Effective jschmied©2013
  • 4. CLINICAL TRIALS Control Trials => Study Subjects are given Placebos! Experimental Trials=> Study Subjects are given the Experimental Medicine
  • 5. CLINICAL TRIALS TEST EFFECTIVENESS & SAFETY Some people volunteer for lots of Clinical trials! jschmied©2013
  • 6. PLACEBOS & THE PLACEBO EFFECT What is a placebo anyways? jschmied©2013
  • 7. 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. jschmied©2014
  • 8. DO DOCTORS GIVE PLACEBOS? jschmied©2013
  • 9. 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. jschmied©2013
  • 12. “If I don’t think it’s going to work, will it still work?” jschmied©2013
  • 13. The Opposite of the Placebo Effect is the Nocebo Effect jschmied©2013
  • 14. CLINICAL TRIALS IN A NUTSHELL jschmied©2013
  • 15. HOW TO CALCULATE SAFETY & EFFECTIVENESS USING CLINICAL TRIAL DATA jschmied©2013
  • 16. INFORMED CONSENT - 2 PARTS 1. KNOW THE RISKS & 2. AGREE TO PARTICIPATE jschmied©2014
  • 17. HOW TO CALCULATE EFFECTIVENESS USING CLINICAL TRIAL DATA 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 tested one has to subtract ET = the % people who report being cured with the medicine - CT = the % people who report being cured with a placebo Effectiveness jschmied©2014 Data Table 2 – A Clinical Trial Same as yellow (not cured) Better than yellow (cured) Worse than Yellow (cured w/side effects) Sampl e size Control Trial (Placebo) 5 33% 1 7% 9 60% 15 Experimental Trial (Medicine) 1 7% 12 69% 2 14% 14
  • 18. HOW TO CALCULATE EFFECTIVENESS USING CLINICAL TRIAL DATA Do the Math and check your answer on the next slide jschmied©2014 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 Experiment al Trial (Medicine) 1 7% 12 69% 2 14% 14
  • 19. 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 Experiment al Trial (Medicine) 1 7% 12 69% 2 14% 14 ET = 69% + 14% = 83% - CT = 7% + 60% = 67% Med Effectiveness = 16% Step Two Do the Math! In this scenario the Placebo Effect is 67%! Thus, the drug is Not very Effective = 16%! jschmied©2014
  • 20. HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA 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 tested one has to subtract the Orange Zone data from 100% 100 - The % people who report being cured w/side effects in the ET jschmied©2014 = % Safety (of the medicine) Data Table 2 – A Clinical Trial Not Cured Cured Cured 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
  • 21. HOW TO CALCULATE SAFETY & EFFECTIVENESS USING CLINICAL TRIAL DATA Data Table 2 – A Clinical Trial Not Cured Cured Cured with Side Effects Sample size Control Trial (Placebo) 5 33 % 1 7% 9 60% 15 Experime ntal Trial (Medicine) 1 7% 12 69% 2 14% 14 Do the Math and check your answer on the next slide! jschmied©2014
  • 22. HOW TO CALCULATE SAFETY WITH CLINICAL TRIAL DATA Data Table 2 – A Clinical Trial Not Cured Cured Doing the Math Cured with Side Effects Sample size Control Trial (Placebo) 5 33 % 1 7% 9 60% 15 Experimen tal Trial (Medicine) 1 7% 12 69% 2 14% 14 100% -14% (% cured but have side effects) 86% Safe (% with no side effects) jschmied©2014
  • 23. THATS ALL FOLKS!!!! jschmied©2014