Eslam Maher
@eslammaher.bsky.social
Oncology trials and biostatistics https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
I was referring to this one: onlinelibrary.wiley.com/doi/abs/10.1...
Design and sample size determination for multiple‐dose randomized phase II trials for dose optimization
The U.S. Food and Drug Administration (FDA) has launched Project Optimus to shift dose selection from the maximum tolerated dose (MTD) to the dose that produces the optimal risk-benefit tradeoff. One...
onlinelibrary.wiley.com
December 7, 2025 at 9:54 PM
I was referring to this one: onlinelibrary.wiley.com/doi/abs/10.1...
Thanks a lot for replying! When do you think is a single-arm trial appropriate? Estimation?
December 7, 2025 at 9:51 PM
Thanks a lot for replying! When do you think is a single-arm trial appropriate? Estimation?
...Novel designs using randomisation, like MERIT, seem to compare each arm against against an assumed fixed population rates too IN EACH ARM.
December 6, 2025 at 10:36 PM
...Novel designs using randomisation, like MERIT, seem to compare each arm against against an assumed fixed population rates too IN EACH ARM.
I would love to hear what you think of single arms in the phase 1 dose finding/optimization setting. Which is virtually 100% of onc trials. Optimus explicitly encourages randomisation.
December 6, 2025 at 10:36 PM
I would love to hear what you think of single arms in the phase 1 dose finding/optimization setting. Which is virtually 100% of onc trials. Optimus explicitly encourages randomisation.
I am tempted to try and simulate a single arm sampled from a true response rate of 0.75, test against a null response rate 0.4, and compare that design to a 2-arm RCT sampled from 0.75 and 0.4. Surely someone has done it, no?
December 6, 2025 at 10:30 PM
I am tempted to try and simulate a single arm sampled from a true response rate of 0.75, test against a null response rate 0.4, and compare that design to a 2-arm RCT sampled from 0.75 and 0.4. Surely someone has done it, no?