What question did this study set out to answer?

To evaluate and compare the sensitivity and specificity of randomized control trials and historical control trials in establishing therapeutic efficacy.

April 1, 1983Archives of Internal Medicine

Sensitivity and Specificity of Clinical Trials

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Authors

HSHenry S. SacksIcahn School of Medicine at Mount Sinai

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Implication

Comparative review reveals higher specificity but lower sensitivity in randomized trials across six therapies, indicating high false-positive rates in historical controls.

Key Points

To evaluate and compare the sensitivity and specificity of randomized control trials and historical control trials in establishing therapeutic efficacy.
Reviewed published literature for six medical therapies evaluated by both randomized control trials and historical control trials.
Calculated sensitivity and specificity for both study designs by integrating published trial conclusions across all possible combinations of true efficacy.
Historical control trials showed high sensitivity (range: 0.80 to 1.00; mean: 0.90) but markedly low specificity (range: 0.0 to 0.27; mean: 0.11).
Randomized control trials demonstrated low sensitivity (range: 0.0 to 0.27; mean: 0.12) but high specificity (range: 0.67 to 1.00; mean: 0.88).

Cite This Study

Henry S. Sacks (1983) studied this question.

synapsesocial.com/papers/6a088fac280cd4e998e8cac5 https://doi.org/10.1001/archinte.1983.00350040143020

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Implication

Comparative review reveals higher specificity but lower sensitivity in randomized trials across six therapies, indicating high false-positive rates in historical controls.

Sensitivity and Specificity of Clinical Trials

Discussion

Member takes

Implication

Key Points

Cite This Study

Sensitivity and Specificity of Clinical Trials

Discussion

Member takes

Implication

Key Points

Cite This Study

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