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Statistical inference and power analysis for direct and spillover effects in two-stage randomized experiments.

Zhichao JiangKosuke ImaiAnup Malani
Published in: Biometrics (2022)
Two-stage randomized experiments become an increasingly popular experimental design for causal inference when the outcome of one unit may be affected by the treatment assignments of other units in the same cluster. In this paper, we provide a methodological framework for general tools of statistical inference and power analysis for two-stage randomized experiments. Under the randomization-based framework, we consider the estimation of a new direct effect of interest as well as the average direct and spillover effects studied in the literature. We provide unbiased estimators of these causal quantities and their conservative variance estimators in a general setting. Using these results, we then develop hypothesis testing procedures and derive sample size formulas. We theoretically compare the two-stage randomized design with the completely randomized and cluster randomized designs, which represent two limiting designs. Finally, we conduct simulation studies to evaluate the empirical performance of our sample size formulas. For empirical illustration, the proposed methodology is applied to the randomized evaluation of the Indian National Health Insurance Program. An open-source software package is available for implementing the proposed methodology.
Keyphrases
  • double blind
  • open label
  • placebo controlled
  • phase iii
  • phase ii
  • health insurance
  • clinical trial
  • randomized controlled trial
  • single cell
  • study protocol