The editorial board of the Statistics in Biopharmaceutical Research (SBR) journal plans to publish a special issue on Vaccines and Biologics. The special issue is motivated by the recognition that there are many unique statistical issues and challenges in vaccines and biologics development arising from the complex biological nature of these two classes of therapeutic products . The special issue seeks to publish high quality manuscripts focused on innovative approaches and reviews related to the statistical design, modeling and analysis of clinical and nonclinical studies of vaccines and biologics. Innovative statistical designs in clinical trials, statistical approaches to biosimilarity, especially as relating to regulatory considerations and reviews of the literature are especially welcome, although a broad range of statistical topics is anticipated.
Timelines and submission instructions for the special Vaccines and Biologics issue of the SBR:
1. The window for submission will be November 1, 2019 – June 30, 2019. Submissions are made through the SBR portal at http://www.tandfonline.com/toc/usbr20/current
2. At the time of the submission of the manuscript, authors are asked to check the VB2019 selection box at Step 1 on the submission page, so the manuscript will be designated for the 2019 Vaccines and Biologics special issue.
3. Manuscripts will go through the standard SBR refereeing process.
4. Goal is to have a set of papers ready for publication in late 2020.
We appreciate your consideration and contributions to make the special issue of the SBR a showcase for cutting edge statistical methods and applications on vaccines and biologics.
Stan Altan (Janssen R&D) and Frank Liu (Merck R&D), Editors .