Rechallenge Assessment - Tratment intervention for entry of Rechallenge
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For assessment of Rechallenge values with the safety database, should a user consider the treatment intervention provided to the patient?
For assessment of Dechallenge values, if treatment is provided (corrective medication for the event), then Dechallenge is considered Not Applicable. Should similar logic also be applied for Rechallenge assessment? Please let us know if it is better to consider Rechallenge independently (despite administration of corrective medication) due to it's importance in E2B submission and signaling purposes.
RQA GPvP Committee
This is not a simple question to answer as the process for rechallenge (re-introducing the suspected medicine after a dechallenge) and dechallenge (stopping of the drug, usually after an adverse event (AE) or at the end of a planned treatment) is not an exact science. The wider context of the treatment should also be taken into account e.g. the disease in question, the clinical setting, the timing of the disappearance / reappearance of the adverse event, concomitant medications, etc. which may make the dechallenge / rechallenge hard to interpret and therefore clinical judgment is also an essential component within the process.
Rechallenge is considered to be justifiable only when the benefit of reintroducing the suspected medicine to the patient outweighs the risk of recurrence of the reaction, in some cases the reaction may be more severe on repeated exposure, and therefore rechallenge requires ethical considerations as well.
The relevant Protocol (as well as data entry guidelines) should provide sufficient detail of what are considered as dechallenge / rechallenge criteria – this then enables consistency to be maintained and documented.
Further information can be located on websites e.g. CIOMS Working Group, FDA