Advanced Statistical Methods Novel Design and Analysis of Clinical Trials
A special issue of Mathematics (ISSN 2227-7390). This special issue belongs to the section "D1: Probability and Statistics".
Deadline for manuscript submissions: 10 January 2026 | Viewed by 7
Special Issue Editor
Interests: adaptive design; N-of-1 trial design; master protocol design; real-world data (RWD) and real-world evidence (RWE); rare disease drug development; bioequivalence for generic drugs; biosimilarity for biosimilar products
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
In recent years, regulatory agencies such as the United States Food and Drug Administration (FDA) have undertaken several critical clinical initiatives to assist sponsors or principal investigators (PIs) in drug research and development. These critical clinical initiatives include, but are not limited to, adaptive trial design, real-world data and real-world evidence (RWD/RWE), biomarker development, biosimilar product development, rare disease drug development, model-informed drug development (MIDD), and benefit-risk assessment. The purpose of these critical clinical initiatives is not only to provide flexibility and efficiency but also to increase the probability of success in drug development. The ultimate goal is to speed up and improve regulatory review and approval process. Thus, the purpose of this Special Issue is not only to provide current statistical methods regarding the novel design and analysis of each initiative, but also to provide an update on recent development from both regulatory and statistical/clinical perspectives.
Prof. Dr. Shein-Chung Chow
Guest Editor
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Mathematics is an international peer-reviewed open access semimonthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
Keywords
- adaptive design
- real-world data/evidence (RWD/RWE)
- biomarker development
- rare disease drug development
- AI
- machine learning
- model-informed drug development (MIDD)
- biosimilar product development
- benefit–risk assessment
Benefits of Publishing in a Special Issue
- Ease of navigation: Grouping papers by topic helps scholars navigate broad scope journals more efficiently.
- Greater discoverability: Special Issues support the reach and impact of scientific research. Articles in Special Issues are more discoverable and cited more frequently.
- Expansion of research network: Special Issues facilitate connections among authors, fostering scientific collaborations.
- External promotion: Articles in Special Issues are often promoted through the journal's social media, increasing their visibility.
- e-Book format: Special Issues with more than 10 articles can be published as dedicated e-books, ensuring wide and rapid dissemination.
Further information on MDPI's Special Issue policies can be found here.
