Innovating the BRACE Trial for the BCG Vaccine in COVID-19

Introduction :

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The Bacille Calmette-Guérin (BCG) vaccine, originally developed to fight tuberculosis, has been recognised for its broader immune-boosting properties. During the global challenges of the COVID-19 pandemic, the Murdoch Children's Research Institute (MCRI) launched the BRACE Trial to determine if the BCG vaccine could reduce the severity of COVID-19 symptoms. This large-scale randomised controlled trial (RCT) extends over five countries and involves over 6,000 participants. It required innovative strategies to ensure effective patient engagement and reliable data collection. To meet these needs, MCRI partnered with WeGuide, a digital health platform, to deliver a customised solution that overcame the logistical complexities of the trial.

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The challenge :

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The BRACE Trial needed to function entirely remotely due to worldwide restrictions, requiring the development of a digital platform that could facilitate patient engagement without face-to-face interaction. Time constraints were another major hurdle, as the platform had to be designed, tested, and deployed within a three-week timeframe. Furthermore, the scale of the trial demanded a system capable of securely capturing daily symptom data from thousands of participants across multiple countries.

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The solution :

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The solution involved updating the WeGuide data capture system, customising its functionality to meet the BRACE Trial requirements and integrating it into REDCap as the data capture platform. Collaboration with MCRI researchers enabled rapid development, allowing the team to deliver a digital solution within three weeks instead of months. This integration ensured secure, efficient, and centralised management of participant data. The WeGuide app enabled participants to log their daily symptoms, stay updated on trial developments, and remain actively involved throughout the study. By combining the flexibility of the WeGuide platform with the data management capabilities of REDCap, the solution established a reliable system for patient engagement and data collection.

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The Outcome :

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The adoption of WeGuide's platform improved the BRACE clinical trial’s ability to achieve its objectives with precision and efficiency. The digital solution facilitated the trial’s launch within six weeks, ensuring the timely collection of essential data. Participant adherence exceeded 90%, highlighting the platform's role in supporting patient engagement and simplifying data reporting. The platform effectively managed data from over 6,000 participants across five countries, demonstrating its ability to handle the complexities of a large-scale clinical trial. This collaboration highlighted the importance of digital tools in enhancing patient engagement, addressing logistical challenges, and improving the quality and reliability of clinical research.

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Conclusion :

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The BRACE Trial highlights the potential of digital platforms to transform patient engagement in clinical trials, particularly during times of global challenges. By partnering with WeGuide, MCRI not only ensured the successful implementation of the trial but also set a benchmark for integrating digital solutions into large-scale RCTs. The innovative approach adopted in the BRACE Trial highlights the importance of leveraging technology to address complex demands and secure reliable outcomes in clinical research.