EASD in 2 weeks! A lot of weight-loss numbers are about to drop..including 3 major studies from
@EliLillyandCo.
Before we understand a molecule’s performance we need to understand design choices that move a topline weight loss number:
- Baseline & mix. BMI, diabetes status, sex and ethnicity all shift observed response
-Stats methods. Treatment-policy and efficacy estimands answer different questions and trial drop out matters for real world outcomes. Mixing them is not appropriate.
- Uncontrolled tails. Open-label extensions and crossovers can keep weight falling after randomization ends. That is not a new efficacy estimate.
- Execution. Lifestyle intensity, titration schedule, time at maintenance dose, and placebo-arm drop-in of approved medicines (important new trend..see ADA survo data).
Head-to-head data settle all this and should be much more widely used in the future. Where they don't exist, an indirect comparison is one data point — anchored, covariate-adjusted, prespecified, assumptions stated.
Those rules apply to our work too. Hold us to them.
Methods first. Then the number.