Patient case studies
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Are real patient case studies, used to illustrate before and after effects, which were not taken from the efficacy studies in the PM, acceptable in a branded piece?
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Hello @charlton
A real patient case can be used when it can be supported by statistically significant pre-defined endpoints from a randomized control trial (RCT) (s3.1.3). The outcomes discussed should be consistent with the outcomes from the trial and within the limitations of the TMA (PM). Effects which are not directly supported by statistically significant data from a RCT, would not be acceptable. The patient case would be required to be disclaimed to be clear and complete.
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Thanks for your reply. However, I'm still not clear about whether the patient is required to have been one of the patients included in the trial included in the PM.
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Hey @charlton
No, a patient case is not required to be on a patient who actually participated in the PM trial.
