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Synexus recruit 2,000+ children for trial

UK-based Synexus has recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus

UK-based Synexus has recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus.

The company, the world's largest multi-national company dedicated to the recruitment and running of clinical trials, has recruited over 2,000 children aged between five and 10 weeks of age, over the course of three months. This is the largest single source of subjects for this phase III trial, which involves over 3,167 children across South Africa in total.

The aim of the trial was to evaluate the efficacy of the vaccine in the developing world and to assist with WHO pre-qualification of the rotavirus vaccine for use in Africa. Dr Sanet Aspinall, managing director of Synexus in South Africa was the coordinator for 11 sites, involving three organisations, conducting the trial. She said: "Ensuring we recruited subjects to this trial promptly and managed this trial efficiently was vital. We were keen to work with everyone involved to drive this programme forward."

Synexus have worked with sponsors on numerous late-stage vaccine trials. They have a network of wholly-owned Dedicated Research Centres in the UK, CEE and South Africa.

This trial was testimony to the success of their recruitment model and ability to reach out to local communities according to CEO, Michael Fort, who said: "For this trial our knowledge and understanding of the local culture, together with our outreach campaigns and trial sites adjacent to primary healthcare clinics, meant that we rapidly recruited well beyond our target. The outreach campaigns target people who might not have access to regular healthcare or information about the benefit of joining clinical trials.

"Local healthcare professionals work with our staff helping with recruitment and managing the trial. The satellite clinics work well for people who cannot travel to clinical trial sites, but who can reach their community hospital. Client feedback indicates that our model works particularly well for late stage vaccine trials."

Rotavirus kills over half a million children each year, the majority in the developing world, and while vaccines have been licensed for use in many Western countries, they are not yet available in parts of Africa where they are needed most.

26th November 2009

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