LAUSR

This special issue is contributed by the participants of the International Chinese Statistical Association (ICSA) Applied Statistics Symposium, held virtually in September 2021. The symposium was organized by the committees from academia, industry and government, and co-sponsored by 16 companies from the pharmaceutical and related industry. The speakers from the symposium were invited to submit papers within the scope of the Journal of Biopharmaceutical Statistics, which features timely and innovative ideas that are pertinent to design, conduct and analysis in all areas of pharmaceutical product research and development. This issue receives submissions that cover a plethora of topics: platform trial designs are proposed to utilize surrogate information (Zhong et al. 2022), or consider multiple endpoints (He et al. 2022); Bayesian designs are proffered for sample size justification in single-arm trials (Ji et al. 2022) or for safety monitoring in multi-stage dose expansion (Wang and Tan 2022); innovative analysis approaches for subgroup effects employing machine learning techniques (Pan et al. 2022) or for estimating regional effects with ordinal outcomes via semi-parametric methods (Duan et al. 2022) are also discussed; causal inference techniques were incorporated with combination tests to handle nonproportional hazard for indirect comparison (Lin et al. 2022). Our sincere appreciation goes to the conference organizers, the authors and referees for their contributions. In addition, we would like to express our gratitude to Dr. Margaret Gamalo-Sierbers, the Journal’s Editor-in-Chief who is instrumental in this partnership, for the opportunity to curate this special issue, and to Dr. Victoria Chang for her editorial guidance.