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result sql = Comparative effectiveness clinical trials in psychiatry: superiority, noninferiority, and the role of active comparators.
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result sql = UNLABELLED : The Agency for Healthcare Research and Quality, part of the US Department of Health and Human Services, has issued several Requests for Applications to conduct comparative effectiveness research (CER). Many of the applications will involve randomized controlled clinical trials that include an active comparator. The inclusion of an active comparator has implications for clinical trial design. Despite a common misperception, a clinical trial result of no significant difference between active treatment groups does not imply equivalence or noninferiority. A noninferiority trial, on the other hand, can directly test whether one active treatment group is noninferior to the other. For example, noninferiority of an inexpensive generic could be tested in comparison with a novel, more costly intervention. Although seldom used in psychiatry, noninferiority clinical trials could play a fundamental role in CER. Features of noninferiority and the nearly ubiquitous superiority designs are contrasted. The noninferiority margin is defined and its application and interpretation are discussed.
CONCLUSIONS : Evidence of noninferiority can only come from well-designed and conducted noninferiority CER. Sample sizes needed in noninferiority trials and in superiority trials that include an active comparator are substantially larger than those needed in trials that can utilize a placebo control in their scientific design. As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo.
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result sql = Comparative effectiveness clinical trials in psychiatry: superiority, noninferiority, and the role of active comparators.
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char = o;code = 111
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char = g;code = 103
char = h;code = 104
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char = d;code = 100
char = o;code = 111
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char = s;code = 115
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char = d;code = 100
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = p;code = 112
char = s;code = 115
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char = n;code = 110
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char = s;code = 115
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char = C;code = 67
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char = I;code = 73
char = O;code = 79
char = N;code = 78
char = S;code = 83
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char = ;code = 32
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char = n;code = 110
char = i;code = 105
char = n;code = 110
char = f;code = 102
char = e;code = 101
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char = i;code = 105
char = o;code = 111
char = r;code = 114
char = i;code = 105
char = t;code = 116
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char = ;code = 32
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char = a;code = 97
char = n;code = 110
char = ;code = 32
char = o;code = 111
char = n;code = 110
char = l;code = 108
char = y;code = 121
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = e;code = 101
char = ;code = 32
char = f;code = 102
char = r;code = 114
char = o;code = 111
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char = l;code = 108
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char = s;code = 115
char = i;code = 105
char = g;code = 103
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char = e;code = 101
char = d;code = 100
char = ;code = 32
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char = d;code = 100
char = ;code = 32
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char = e;code = 101
char = d;code = 100
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char = o;code = 111
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char = i;code = 105
char = n;code = 110
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char = e;code = 101
char = r;code = 114
char = i;code = 105
char = o;code = 111
char = r;code = 114
char = i;code = 105
char = t;code = 116
char = y;code = 121
char = ;code = 32
char = C;code = 67
char = E;code = 69
char = R;code = 82
char = .;code = 46
char = ;code = 32
char = S;code = 83
char = a;code = 97
char = m;code = 109
char = p;code = 112
char = l;code = 108
char = e;code = 101
char = ;code = 32
char = s;code = 115
char = i;code = 105
char = z;code = 122
char = e;code = 101
char = s;code = 115
char = ;code = 32
char = n;code = 110
char = e;code = 101
char = e;code = 101
char = d;code = 100
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = n;code = 110
char = o;code = 111
char = n;code = 110
char = i;code = 105
char = n;code = 110
char = f;code = 102
char = e;code = 101
char = r;code = 114
char = i;code = 105
char = o;code = 111
char = r;code = 114
char = i;code = 105
char = t;code = 116
char = y;code = 121
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char = t;code = 116
char = r;code = 114
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = s;code = 115
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char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = p;code = 112
char = e;code = 101
char = r;code = 114
char = i;code = 105
char = o;code = 111
char = r;code = 114
char = i;code = 105
char = t;code = 116
char = y;code = 121
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = s;code = 115
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = a;code = 97
char = t;code = 116
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = c;code = 99
char = l;code = 108
char = u;code = 117
char = d;code = 100
char = e;code = 101
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = ;code = 32
char = a;code = 97
char = c;code = 99
char = t;code = 116
char = i;code = 105
char = v;code = 118
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = p;code = 112
char = a;code = 97
char = r;code = 114
char = a;code = 97
char = t;code = 116
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = a;code = 97
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = s;code = 115
char = u;code = 117
char = b;code = 98
char = s;code = 115
char = t;code = 116
char = a;code = 97
char = n;code = 110
char = t;code = 116
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = l;code = 108
char = y;code = 121
char = ;code = 32
char = l;code = 108
char = a;code = 97
char = r;code = 114
char = g;code = 103
char = e;code = 101
char = r;code = 114
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = a;code = 97
char = n;code = 110
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = o;code = 111
char = s;code = 115
char = e;code = 101
char = ;code = 32
char = n;code = 110
char = e;code = 101
char = e;code = 101
char = d;code = 100
char = e;code = 101
char = d;code = 100
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = s;code = 115
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = a;code = 97
char = t;code = 116
char = ;code = 32
char = c;code = 99
char = a;code = 97
char = n;code = 110
char = ;code = 32
char = u;code = 117
char = t;code = 116
char = i;code = 105
char = l;code = 108
char = i;code = 105
char = z;code = 122
char = e;code = 101
char = ;code = 32
char = a;code = 97
char = ;code = 32
char = p;code = 112
char = l;code = 108
char = a;code = 97
char = c;code = 99
char = e;code = 101
char = b;code = 98
char = o;code = 111
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = n;code = 110
char = t;code = 116
char = r;code = 114
char = o;code = 111
char = l;code = 108
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = i;code = 105
char = r;code = 114
char = ;code = 32
char = s;code = 115
char = c;code = 99
char = i;code = 105
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = i;code = 105
char = f;code = 102
char = i;code = 105
char = c;code = 99
char = ;code = 32
char = d;code = 100
char = e;code = 101
char = s;code = 115
char = i;code = 105
char = g;code = 103
char = n;code = 110
char = .;code = 46
char = ;code = 32
char = A;code = 65
char = s;code = 115
char = ;code = 32
char = a;code = 97
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = s;code = 115
char = u;code = 117
char = l;code = 108
char = t;code = 116
char = ,;code = 44
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = s;code = 115
char = ;code = 32
char = w;code = 119
char = i;code = 105
char = t;code = 116
char = h;code = 104
char = ;code = 32
char = a;code = 97
char = c;code = 99
char = t;code = 116
char = i;code = 105
char = v;code = 118
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = p;code = 112
char = a;code = 97
char = r;code = 114
char = a;code = 97
char = t;code = 116
char = o;code = 111
char = r;code = 114
char = s;code = 115
char = ;code = 32
char = a;code = 97
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = m;code = 109
char = o;code = 111
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = s;code = 115
char = t;code = 116
char = l;code = 108
char = y;code = 121
char = ,;code = 44
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = q;code = 113
char = u;code = 117
char = i;code = 105
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = l;code = 108
char = o;code = 111
char = n;code = 110
char = g;code = 103
char = e;code = 101
char = r;code = 114
char = ;code = 32
char = r;code = 114
char = e;code = 101
char = c;code = 99
char = r;code = 114
char = u;code = 117
char = i;code = 105
char = t;code = 116
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = d;code = 100
char = u;code = 117
char = r;code = 114
char = a;code = 97
char = t;code = 116
char = i;code = 105
char = o;code = 111
char = n;code = 110
char = ,;code = 44
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = d;code = 100
char = ;code = 32
char = e;code = 101
char = x;code = 120
char = p;code = 112
char = o;code = 111
char = s;code = 115
char = e;code = 101
char = ;code = 32
char = m;code = 109
char = o;code = 111
char = r;code = 114
char = e;code = 101
char = ;code = 32
char = p;code = 112
char = a;code = 97
char = r;code = 114
char = t;code = 116
char = i;code = 105
char = c;code = 99
char = i;code = 105
char = p;code = 112
char = a;code = 97
char = n;code = 110
char = t;code = 116
char = s;code = 115
char = ;code = 32
char = t;code = 116
char = o;code = 111
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = r;code = 114
char = i;code = 105
char = s;code = 115
char = k;code = 107
char = s;code = 115
char = ;code = 32
char = o;code = 111
char = f;code = 102
char = ;code = 32
char = a;code = 97
char = n;code = 110
char = ;code = 32
char = e;code = 101
char = x;code = 120
char = p;code = 112
char = e;code = 101
char = r;code = 114
char = i;code = 105
char = m;code = 109
char = e;code = 101
char = n;code = 110
char = t;code = 116
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = a;code = 97
char = n;code = 110
char = ;code = 32
char = d;code = 100
char = o;code = 111
char = ;code = 32
char = t;code = 116
char = r;code = 114
char = i;code = 105
char = a;code = 97
char = l;code = 108
char = s;code = 115
char = ;code = 32
char = i;code = 105
char = n;code = 110
char = ;code = 32
char = w;code = 119
char = h;code = 104
char = i;code = 105
char = c;code = 99
char = h;code = 104
char = ;code = 32
char = t;code = 116
char = h;code = 104
char = e;code = 101
char = ;code = 32
char = o;code = 111
char = n;code = 110
char = l;code = 108
char = y;code = 121
char = ;code = 32
char = c;code = 99
char = o;code = 111
char = m;code = 109
char = p;code = 112
char = a;code = 97
char = r;code = 114
char = a;code = 97
char = t;code = 116
char = o;code = 111
char = r;code = 114
char = ;code = 32
char = i;code = 105
char = s;code = 115
char = ;code = 32
char = p;code = 112
char = l;code = 108
char = a;code = 97
char = c;code = 99
char = e;code = 101
char = b;code = 98
char = o;code = 111
char = .;code = 46
result sql = UNLABELLED : The Agency for Healthcare Research and Quality, part of the US Department of Health and Human Services, has issued several Requests for Applications to conduct comparative effectiveness research (CER). Many of the applications will involve randomized controlled clinical trials that include an active comparator. The inclusion of an active comparator has implications for clinical trial design. Despite a common misperception, a clinical trial result of no significant difference between active treatment groups does not imply equivalence or noninferiority. A noninferiority trial, on the other hand, can directly test whether one active treatment group is noninferior to the other. For example, noninferiority of an inexpensive generic could be tested in comparison with a novel, more costly intervention. Although seldom used in psychiatry, noninferiority clinical trials could play a fundamental role in CER. Features of noninferiority and the nearly ubiquitous superiority designs are contrasted. The noninferiority margin is defined and its application and interpretation are discussed.
CONCLUSIONS : Evidence of noninferiority can only come from well-designed and conducted noninferiority CER. Sample sizes needed in noninferiority trials and in superiority trials that include an active comparator are substantially larger than those needed in trials that can utilize a placebo control in their scientific design. As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo.
Publication: J Clin Psychiatry 2011 Oct ;72(10)::1344-9. :doi: 10.4088/JCP.10m06089whi.
Publication Date: 2011 Oct
Study Author(s): Leon, Andrew C;
Institution: Weill Cornell Medical College, Departments of Psychiatry and Public Health, New York, NY 10065, USA. [email protected]
Shortcut link to this study:
Publication Date: 2011 Oct
Study Author(s): Leon, Andrew C;
Institution: Weill Cornell Medical College, Departments of Psychiatry and Public Health, New York, NY 10065, USA. [email protected]
Shortcut link to this study:
UNLABELLED : The Agency for Healthcare Research and Quality, part of the US Department of Health and Human Services, has issued several Requests for Applications to conduct comparative effectiveness research (CER). Many of the applications will involve randomized controlled clinical trials that include an active comparator. The inclusion of an active comparator has implications for clinical trial design. Despite a common misperception, a clinical trial result of no significant difference between active treatment groups does not imply equivalence or noninferiority. A noninferiority trial, on the other hand, can directly test whether one active treatment group is noninferior to the other. For example, noninferiority of an inexpensive generic could be tested in comparison with a novel, more costly intervention. Although seldom used in psychiatry, noninferiority clinical trials could play a fundamental role in CER. Features of noninferiority and the nearly ubiquitous superiority designs are contrasted. The noninferiority margin is defined and its application and interpretation are discussed.
CONCLUSIONS : Evidence of noninferiority can only come from well-designed and conducted noninferiority CER. Sample sizes needed in noninferiority trials and in superiority trials that include an active comparator are substantially larger than those needed in trials that can utilize a placebo control in their scientific design. As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo.
CONCLUSIONS : Evidence of noninferiority can only come from well-designed and conducted noninferiority CER. Sample sizes needed in noninferiority trials and in superiority trials that include an active comparator are substantially larger than those needed in trials that can utilize a placebo control in their scientific design. As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo.
PMID: 21367350
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