Adjusting for both sequential testing and systematic error in safety surveillance using observational data: Empirical calibration and MaxSPRT.

"we make our simulation r code available in the supplementary material 6 2 figures4 and 5 show the results of our synthetic experiment using the historical comparator design and sccs design respectively. we make our simulation r code available in the supplementary material 6 2 figures4 and 5 show the results of our synthetic experiment using the historical comparator design and sccs design respectively.; the simulated data can be reconstructed using the r code provided in the supplementary materials."

"CONFLICT OF INTEREST Martijn J. Schuemie is an employee of Janssen Research & Development and shareholder in Johnson & Johnson. Marc A. Suchard receives contracts and grants from the US Food & Drug Administration, the US Department of Veterans Affairs, the US National Institutes of Health and Janssen Research & Development, the latter two unrelated to the scope of this work."

"Funding information US Food & Drug Administration, Grant/Award Number: 75F40120D00039"