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Proper clinical design

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Is it necessary for every human clinical trial to include both positive and negative controls in order to gain perspective on the effectiveness of a specific treatment?

Clinical Research
Clinical Trials
Design of Experiments
Robert Faller
29 months ago

4 answers

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I think that negative controls are always needed, unless there is a preliminary evidence or a well sounded hypothesis of a clear advantage of the new treatment over the gold standard positive treatment. In that case it could be reasonable to plan a clinical trial with only positive controls, taking in mind that if the results tell us that there is not a clear difference between treatments and the efficacy is not high, we can't rule out the assay sensitivity problem.

Ugo Lancia
29 months ago
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Without both, how would you be able to confirm that the model itself has sufficient ability to differentiate? In other words, if all we see is something that is better than nothing, is that sufficient to provide perspective, or do you really require both in order to be able to accurately assess overall performance?

Robert Faller
29 months ago
I would say that positive control is always necessary, at least in phase III. As I wrote before, negative controls could in some instance be not necessary, provided that the new treatment proves clearly superior to the gold standard - Ugo 29 months ago
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I would say that positive control is always necessary, at least in phase III. As I wrote before, negative controls could in some instance be not necessary, provided that the new treatment proves clearly superior to the gold standard - Ugo

Ugo Lancia
29 months ago
ok - thanks for your input; much appreciated - Robert 29 months ago
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You welcome. Happy to be of help. Ugo

Ugo Lancia
29 months ago

Have some input?