Trial Statistics and Governance

Cross-source consensus on Trial Statistics and Governance from 1 sources and 6 claims.

1 sources · 6 claims

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Accounting for 20% dropout or non-response, the study requires 110 participants per arm and 220 participants total. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer
The trial received HRA and HCRW approval from Bromley South East London REC on 23 September 2025. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer
The trial is powered to detect minimally important differences in EPIC-26 domains using an effect size of 0.5, 80% power, and 5% two-sided significance. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer
The primary analysis compares mean EPIC-26 score differences from baseline at 5 years using a t-test or Mann-Whitney U test depending on distribution. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer
An interim analysis will occur after 110 randomized participants complete 6 months of follow-up. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer
Trial data are managed in REDCap with audit trails, pseudonymised identifiers, and GDPR-compliant archiving for at least 5 years after the study. — The LDR BURST trial: a randomised controlled trial comparing the side effects of low-dose-rate brachytherapy against ultra-hypofractionated radiotherapy using spacer gel treatment in men with Cambridge Prognostic Groups 1–3 prostate cancer