The New England Journal of Statistics in Data Science (NEJSDS) pleased to invite submissions to a special issue of "Clinical Trial Designs Involving Multiple Stages and Re-Randomization Beyond Traditional Randomization". This special issue focuses on recent developments in statistical methods and novel applications or case studies using re-randomization and related topics.

Manuscripts for this special Issue should be submitted by September 30, 2024 via the journal online submission portal https://www.e-publications.org/ness/sbs/. Please state that your submissions are "For the Special Issue on Re-Randomization and Related Topics" in the Box of Comments to the editors. The submissions will go through a regular review process. As the guest editors for this special issue, we will handle the peer review of the manuscripts timely and adhere high scientific standards.

The tentative topics tentatively organized in three parts include (but not limited to):

Part I: Single Randomization in Randomized Clinical Trials (RCT) versus Re-randomization with Two stage
1. The utility and advantage of re-randomization and its comparison with single randomization in randomized clinical trials
2. Potential Issues of randomized control trials (RCTs), including but not limited to randomization test for exact inference, handing of missing data, the estimand framework, immortal time bias, and the validity of randomization test when the exchangeability is of questionable validity for trials with small sample size.

Part II: Two stage and multistage trial designs where patients from previous stages may be re-randomized to increase the probability of technical success. Special issues that are not present in single stage RCTs are also addressed
1. Introduction and Application of Two-Stage Designs (e.g., Sequential Parallel Comparison Design (SPCD), Adaptive Two Stage Randomized Delayed Start Design, Sequential Multiple Assignment Randomized Trials (SMART)) in clinical trials
2. Estimands Consideration for Two-Stage Designs
3. Statistical Analyses including Missing Data Handling for Two-Stage Designs
4. Strategies of Responder and Non-responder Determination for Two-Stage Designs
5. Sample Size Planning and R-Shiny Software for Two-Stage Designs
6. Adaptive Two-Stage Randomized Delayed Start Designs with Re-Randomization
7. Utilizing Platform Setting, Win Ratio Method, etc. in Multiple-Stage Designs
8. Bayesian Designs for clinical trials with Re-randomization

Part III: Beyond RTC such as singe arm studies against natural history controls
1. Single arm studies comparing with external control via real world data and evidence
2. Innovative Bayesian strategies for efficacy evaluation with design adaptations

NEJSDS is proud to be a pioneer in the reform of the traditional peer review process by implementing a new hybrid journal review process. In this new review process, authors have the option to supply referee reports invited by the authors, as a supplement to the traditional review reports led by the editorial board. The decisions will take into consideration both review reports initiated by the authors and the reports initiated by the editorial board. If any authors choose to provide open reviews for their articles, please mention it in the cover letter and upload the review reports (including the information of reviewers’ affiliations and email addresses) as supplementary materials when submitting the article.

If you have any questions or would like to make pre-submission inquiry, please feel free to contact us.

We look forward to receiving your papers in due course.

Guest Editors:

• Michael Proschan, National Institute of Allergy and Infectious Diseases, email: proscham@niaid.nih.gov
• Yeh-Fong Chen, U.S. Food and Drug Administration, email: yehfong.chen@fda.hhs.gov
• Feiran Jiao, U.S. Food and Drug Administration, email: feiran.jiao@fda.hhs.gov
• Qing Liu, QRMedSci, LLC, email: liu.qing@qrmedsci.net