We review and compare existing methods for sample size calculation based on the logrank statistic and recommend the method of Lakatos for its accuracy and flexibility in allowing time-dependent rates of event, loss to follow-up, and noncompliance. We extend the Lakatos method to allow a general follow-up scheme, to handle non-inferiority tests, and to predict the number of events over calendar time. We apply the Lakatos method to the simple nonproportional hazard situation of delayed treatment effect to facilitate the comparison of different weighting methods and to evaluate the performance of the maximum combination tests. We use simulation studies to confirm the validity of the Lakatos method and its extensions.
Keywords: delayed treatment effect; logrank test; loss to follow-up; noncompliance; nonproportional hazards.
© 2020 John Wiley & Sons Ltd.