# Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics

## TL;DR

This paper proposes a new clinical trial design to better evaluate treatments for Lassa fever, addressing current limitations in evidence and methodology.

## Contribution

The novel adaptive phase II/III platform trial design is tailored to Lassa fever's unique epidemiological challenges.

## Key findings

- An adaptive trial framework is proposed to assess ribavirin and other therapeutics for Lassa fever.
- The design includes interim analysis to handle uncertainties in primary endpoints and sample size estimation.
- Equal allocation and a superiority framework are integrated to improve trial efficiency and relevance.

## Abstract

The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.