Data requirements and protocol for determining non-inferiority of insecticide-treated net and indoor residual spraying products within an established WHO intervention class

Overview

The aim of this protocol is to support the generation of entomological data to inform a decision as to whether a candidate insecticide-treated net or indoor residual spraying product should become part of an existing WHO policy class. An initial set of non-inferiority studies on pyrethroid-PBO nets, planned for 2019, will be used to validate whether the method outlined here serves its intended purpose before a decision will be taken as to whether demonstration of non-inferiority of second-in-class products becomes a standard WHO requirement.

This protocol was updated in May 2019 following an open review process. More information can be found in the consolidated responses to questions and comments received.

Related document

• Meeting report of the ERG on determining non-inferiority of insecticide-treated nets and indoor residual spray products within an established product class