Trial Methodology

The Phase II primary endpoint is objective response rate, and the central hypothesis is that adding IBI305 will raise ORR from approximately 58% to 73%. RCTs are the gold standard for evaluating intervention efficacy and safety, minimising biases and confounding to deliver robust evidence for evidence-based medicine. The design enables both vertical comparisons between concurrent intervention and control clinics and horizontal comparisons within the same clinic before and after its crossover. The pragmatic design embeds research into ordinary clinical workflows and supports external validity, generalisability, and scalability. Ninety adolescents are randomised 1:1 using a block randomisation list generated by an independent statistician via a central web platform. The control group receives only a simulated puncture without subarachnoid puncture, maintaining blinding of patients and outcome assessors. The trial compares MDT with generalised exercise in surgeons with chronic spinal pain and confirmed directional preference. The trial uses a single-blind, two-arm, parallel-group randomised controlled trial design comparing an mHealth app with paper-based cessation materials. The tri…