Click to Swap Windows
Clinical Trials
Randomized Controlled Clinical Trials
Medications vs. Surgery
Study Protocol
Study Protocol - 2
N.I.H. Rules
Study Protocol – 3
Example
Example – 2
Example - 3
Publication in Lancet
Efficacy of Placebo
Side effects of Placebo
Controlled Comparison
Blindfold Evaluation
Triple Blind
Confirmation
Masking
Randomization
Randomization
Random Blocks
When do you randomize?
Cause and Effect ?
Are the groups Typical ?
Typical and Valid
Coronary Drug Project
Coronary Drug Project - 2
Mortality Rates
Coronary Drug Project -3
Coronary Drug Project - 4
Mortality Rate by Adherence
Conclusion:
Evaluation
Quality of Trial
Quality of Trial - 2
Conclusion
STUDY DESIGN



Slide43
Slide44
Slide45
Slide46
Slide47
Slide48
Slide49
Slide50
Slide51
Slide52
Slide53
Slide54
Slide55
Slide56
Slide57
Slide58
Slide59
Slide60
Slide61
Slide62
Slide63
BOGALUSA HEART STUDY
Slide65
Slide66
Slide67
Slide68
Slide69
Slide70
Slide71
Slide72
MEASURES OF DISEASE FREQUENCY
Table 11.2 Grading Types of Clinical Evidence for a Cause-and-Effect Relationship
Slide75
The type of question determines the study design that is most likely to provide a valid answer.
Slide77
Slide78
Which is the best design?
Randomized trial
Ice cream evoked headaches (ICE_H) study: randomized trial of accelerated vs cautious ice cream eating regimen.
Ice cream evoked headaches (ICE_H) study: randomized trial of accelerated vs cautious ice cream eating regimen.
Non-invasive detection of hypoglycemia using a novel, fully biocompatible and patient friendly alarm system.
What kind of study is this?
Slide85
Sex: can you get it right?
What kind of study is this?
Cross-sectional study
Grandmothers’ role in preventing unnecessary accident and emergency room attendance.
What kind of study is this?
Case-control study
Before she lets her child go on an archeological dig, a patient’s mother wants to know whether she should be worried about the “mummy’s curse”. You are astonished to find the following paper:
What kind of study is this?
Cohort study
Slide95
Slide96
Slide97
Slide98
Slide99
Slide100
Slide101
Slide102
Slide103
Slide104
Slide105
Possible Explanations for
Slide107
Slide108
Slide109
Slide110
Slide111
Slide112
Slide113
Slide114
NON-DIFFERENTIAL MISCLASSIFICATION
DIFFERENTIAL MISCLASSIFICATION
Slide117
Slide118
Slide119
Slide120
Slide121
Slide122
Study Design:
Study 1
Study 2
Study 3
Study 4
Introduction to Clinical Research - 11/25/03 - I & II
Click to Swap Windows
Clinical Trials
Randomized Controlled Clinical Trials
Medications vs. Surgery
Study Protocol
Study Protocol - 2
N.I.H. Rules
Study Protocol – 3
Example
Example – 2
Example - 3
Publication in Lancet
Efficacy of Placebo
Side effects of Placebo
Controlled Comparison
Blindfold Evaluation
Triple Blind
Confirmation
Masking
Randomization
Randomization
Random Blocks
When do you randomize?
Cause and Effect ?
Are the groups Typical ?
Typical and Valid
Coronary Drug Project
Coronary Drug Project - 2
Mortality Rates
Coronary Drug Project -3
Coronary Drug Project - 4
Mortality Rate by Adherence
Conclusion:
Evaluation
Quality of Trial
Quality of Trial - 2
Conclusion
STUDY DESIGN



Slide43
Slide44
Slide45
Slide46
Slide47
Slide48
Slide49
Slide50
Slide51
Slide52
Slide53
Slide54
Slide55
Slide56
Slide57
Slide58
Slide59
Slide60
Slide61
Slide62
Slide63
BOGALUSA HEART STUDY
Slide65
Slide66
Slide67
Slide68
Slide69
Slide70
Slide71
Slide72
MEASURES OF DISEASE FREQUENCY
Table 11.2 Grading Types of Clinical Evidence for a Cause-and-Effect Relationship
Slide75
The type of question determines the study design that is most likely to provide a valid answer.
Slide77
Slide78
Which is the best design?
Randomized trial
Ice cream evoked headaches (ICE_H) study: randomized trial of accelerated vs cautious ice cream eating regimen.
Ice cream evoked headaches (ICE_H) study: randomized trial of accelerated vs cautious ice cream eating regimen.
Non-invasive detection of hypoglycemia using a novel, fully biocompatible and patient friendly alarm system.
What kind of study is this?
Slide85
Sex: can you get it right?
What kind of study is this?
Cross-sectional study
Grandmothers’ role in preventing unnecessary accident and emergency room attendance.
What kind of study is this?
Case-control study
Before she lets her child go on an archeological dig, a patient’s mother wants to know whether she should be worried about the “mummy’s curse”. You are astonished to find the following paper:
What kind of study is this?
Cohort study
Slide95
Slide96
Slide97
Slide98
Slide99
Slide100
Slide101
Slide102
Slide103
Slide104
Slide105
Possible Explanations for
Slide107
Slide108
Slide109
Slide110
Slide111
Slide112
Slide113
Slide114
NON-DIFFERENTIAL MISCLASSIFICATION
DIFFERENTIAL MISCLASSIFICATION
Slide117
Slide118
Slide119
Slide120
Slide121
Slide122
Study Design:
Study 1
Study 2
Study 3
Study 4
Introduction to Clinical Research - 11/25/03 - I & II