We are pleased to announce a call for manuscripts for a special issue of Pharmaceutical Statistics, entitled “Project Optimus: Designing Early Phase Dose Optimization Trials in Oncology”.

We cordially invite members of the academic community, industry, and the wider scientific community to submit manuscripts. The submissions should focus on the following topics related to deigning dose optimization trials in oncology:

• Describing the methods for dose optimization in contemporary clinical trials.
• Summary of the current statistical methodology research on adaptive statistical designs for dose
optimization trials, existing challenges and opportunities, and important open problems.
• Summary of existing applications of adaptive designs in contemporary dose optimization trials,
identification of best practices, fit-for-purpose approaches, and relevant statistical software.
• Expanding the methods for dose optimization in contemporary clinical trials.
• Novel adaptive design methods for dose optimization oncology trials.
• Comparison of statistical properties of competing adaptive design methods for dose-
optimization trials.
• Methods of handling various complexities in dose-optimization trials (delayed responses,
missing data, etc.)
• Use of innovative analytic tools and machine learning methods (historical borrowing, Bayesian
hierarchical models, Bayesian learning, etc.) to make dose-optimization studies more efficient.
• Novel analysis and estimation methods for analyzing data following dose optimization
oncology studies.
• Enhancing the collaboration between stakeholders handling dose-optimization trials.
• Modelling and simulation for dose optimization trial designs in oncology.
• Reporting and presenting results from dose optimization trials.
• Extending the concept of dose optimization beyond oncology.

Submissions on other related topics will be considered but priority shall be given to the topics explicitly mentioned above. Expression of interest on the review type papers can be submitted before 15 July  2025. The expression of interest should be presented in a cover letter of no more than 1 page. The cover letter should clearly describe the research problem(s) to be addressed, the contribution to the current body of knowledge on designing early-phase oncology trials to find an optimum dose level, the potential implications for practice, and how it fits within the scope of the special issue.

All manuscripts can be directly submitted online at https://wiley.atyponrex.com/journal/PST. Manuscripts can be submitted until 31 December 2025. Manuscripts are accepted in Word or LaTeX.

Please note that all articles will undergo peer review and there is no guarantee of acceptance for a submission. All papers will be peer-reviewed, according to the reviewing principles of Pharmaceutical Statistics. Accepted papers will be published continuously online on the journal website (as soon as accepted) and will be listed together in the special issue.

Submission Guidelines/Instructions

Please refer to the Author Guidelines to prepare your manuscript. When submitting your manuscript at https://wiley.atyponrex.com/journal/PST, please answer the question: “Is this submission for a special issue?” by selecting the special issue title from the drop-down list.

If you have any questions, please do not hesitate to reach out to Ayon Mukherjee (ayon.mukherjee@lilly.com), Oleksandr Sverdlov (alex.sverdlov@novartis.com), or Ying Yuan (yyuan@mdanderson.org).

Ayon Mukherjee, Oleksandr Sverdlov, Ying Yuan
Guest Associate Editors for the Special Issue on Project Optimus