US BIOTECH, INTERNATIONAL TRIAL

BACKGROUND

A CRO based in the US acting on behalf of an American Biotech company reached out to M2M. They were considering including Australian sites in their Phase 1 paediatric clinical trial due to:

  • the limited recruitment opportunities globally during the COVID 19 pandemic
  • the high prevalence of allergies in Australia.
CHALLENGE

M2M was engaged to initiate Australian sites for the trial and to maintain recruitment and retention despite the global pandemic.

In order to make it very cost effective to include Australia, a local subsidiary was also set up so the Sponsor could apply the R&D tax incentive.


METHODOLOGY

M2M conducted a comprehensive feasibility and site selection to ensure the best suited sites were chosen. A wide geographical spread was selected to mitigate risk of lockdown affecting recruitment/ retention.

Due to potential future lockdown restrictions, M2M also proposed possible ways to maintain patient engagement whilst on the trial, through the implementation of neonatal home visits. This was incorporated into the protocol prior to regulatory approval.

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Study started on time – recruitment as planned and COVID pandemic risk mitigated through the distribution of sites across Australia. Recruitment remains on track despite intermittent lockdowns. Study visits continue to be performed as scheduled with the use of neonatal home visits.

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