Experiences Of Protecting The Blind With Unexpected Events

Hello.

I am hoping someone might be willing to share their practical experiences of how they protect the blind (double blind trials) when dealing with potential SUSARs please, in particular with the following scenarios.

1. When, after unblinding has occurred in preparation to submit a SUSAR, the participant is revealed to be taking placebo, how do you manage communications with site? I feel they should informed the event has not been submitted (for their own tracking / internal reporting purposes) but doing so would surely lead them to infer the pt is on placebo.

2. Regs say ‘Events associated with placebo will usually not satisfy the criteria for a SUSAR. However, where SUSARs are associated with placebo (e.g. reaction due to an excipient or impurity), the sponsor should report such cases’. Has anyone reported a placebo event? At that stage of processing the event would the relatedness be made without inferring the patient is on placebo?

Thank you.

Rachel

PhV Lead, Leeds CTRU.

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