Question
In: Biology
How is a clinical trial for a medical device similar to or different from a clinical...
How is a clinical trial for a medical device similar to or different from a clinical trial for a drug?
Solutions
Expert Solution
The study for a clinical trial for a drug is similar to the study for a clinical trial for a medical device in the following ways
- Both the studies involve a control group.
- Both the trials can compare to the approved therapies.
The clinical trials for a drug differ from the clinical trials for a medical device in the following ways
| Clinical trial for a drug | Clinical trial for a medical device |
| Randomization of samples is common. | Often there is no randomization |
| Involves large population with the use of placebos | Small populations and rarely uses placebos |
| Difficulty in visualization | Ability to visualization |
| Ability to "blind" the samples | Difficult to "blind" |
gladiator answered 3 years agoRelated Solutions
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A clinical trial is run to assess the effects of different forms
of regular exercise on HDL levels in persons between the ages of 18
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Their HDL levels are measured after 8 weeks and are summarized
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A medical researcher wants to begin a clinical trial that involves systolic blood pressure (SBP) and...
A medical researcher wants to begin a clinical trial that
involves systolic blood pressure (SBP) and cadmium (Cd) levels.
However, before starting the study, the researcher wants to confirm
that higher SPB is associated with lower Cd levels. Below are the
SBP and Cd measurements for a sample a participants. What can the
researcher conclude with an α of 0.10?
SBP
Cd
169
183
115
113
182
126
179
127
148
160
140
55.5
55.7
55.8
55.9
55.5
55.7
55.6...
A medical researcher wants to begin a clinical trial that involves systolic blood pressure (SBP) and...
A medical researcher wants to begin a clinical trial that
involves systolic blood pressure (SBP) and cadmium (Cd) levels.
However, before starting the study, the researcher needs to know if
there is a relationship between SBP and Cd. Below are the SBP and
Cd measurements for a sample a participants. What can the
researcher conclude with α = 0.05?
SBP
Cd
169
161
115
113
182
126
179
127
148
160
140
55.9
55.7
55.7
55.5
55.9
55.8
55.8
55.5...
A medical researcher wants to begin a clinical trial that involves systolic blood pressure (SBP) and...
A medical researcher wants to begin a clinical trial that
involves systolic blood pressure (SBP) and cadmium (Cd) levels.
However, before starting the study, the researcher wants to confirm
that higher SBP is associated with higher Cd levels. Below are the
SBP and Cd measurements for a sample a participants. What can the
researcher conclude with an α of 0.01?
SBP
Cd
169
161
115
113
182
126
179
127
148
160
140
56.6
55.7
55.7
55.5
55.9
55.8
55.8...
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researcher conclude with an α of 0.05?
SBP
Cd
126
127
179
182
113
169
115
161
148
140
160
55.9
55.7
55.7
55.5
55.9
55.8
55.8...
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