Useful and well-described proposal to test a novel statistical approach that was developed to detect the efficacy of drugs that have heterogeneous treatment effects; appreciate citation to the preprint of the approach. Investigators have requested access to 2 trials made available via the YODA Project for this work, but make repeated reference to using the Vivli research platform. Unclear why. If investigators are only using these 2 trials made available via Johnson & Johnson for this work, analyses should be conducted in our associated secure, cloud-based research platform. If investigators are planning to use additional trials from other companies and need all the trials to be in a single research environment for analysis, they should pre-specify in this proposal which additional trials are being used and clarify. Based on their description, each trial is being analyzed individually; there is no meta-analysis.
Approve