Clinical Trials 2025–2026. Catalogue 1

 


Medicine & Clinical Research

2025 – 2026

Selected Titles Catalogue

New and Recent Publications

About This Catalogue

This catalogue presents a curated selection of new and recent titles in Clinical Research, Biostatistics, Clinical Trials Methodology, and related medical disciplines, published in 2025 and 2026. Titles have been personally selected for academic medical libraries, research institutions, hospital libraries, and health sciences faculties worldwide. Price includes worldwide shipping via DHL/FedEx.

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Areas Covered

  • Clinical Trials Design and Methodology
  • Estimands and Sensitivity Analysis
  • Biostatistics and Statistical Methods
  • Regulatory Affairs and ICH Guidelines
  • Oncology and Drug Development
  • Evidence-Based Medicine
  • Pharmacoepidemiology
  • Real-World Evidence and Health Technology Assessment
  • Medical Research Ethics
  • Translational and Precision Medicine

New Titles — 2025 / 2026

CLINICAL TRIALS METHODOLOGY

Estimands in Clinical Trials: Principles and Practice

Moye, Lemuel A.

Chapman & Hall / CRC Press | 2025 | Hardcover | ISBN 9781032703787

A rigorous and practical treatment of the estimand framework as defined in ICH E9(R1), covering how researchers should define, design, and analyse clinical trials in full alignment with regulatory expectations. The book addresses intercurrent events, treatment policy strategies, sensitivity analyses, and the statistical principles underpinning each estimand approach. Essential for biostatisticians, clinical researchers, and regulatory professionals navigating modern trial design.

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BIOSTATISTICS

Statistical Methods in Clinical Trials: Advanced Approaches

Jennison, Christopher; Turnbull, Bruce W.

CRC Press | 2025 | Hardcover | ISBN 9781032145823

This advanced text covers group sequential methods, adaptive trial designs, and Bayesian approaches for modern clinical research. Authors provide detailed treatment of interim analyses, sample size re-estimation, and multiplicity adjustments with real case studies from oncology and cardiovascular trials. Indispensable for senior biostatisticians and academic researchers designing complex multi-stage studies.

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REGULATORY & DRUG DEVELOPMENT

Adaptive Designs for Clinical Trials

Chow, Shein-Chung; Chang, Mark

CRC Press | 2025 | Hardcover | ISBN 9781032891880

A comprehensive guide to adaptive trial designs that comply with FDA and EMA regulatory guidance, covering seamless phase II/III designs, sample size adaptation, response-adaptive randomisation, and master protocol frameworks. The text bridges statistical theory with operational implementation and provides worked examples for pharmaceutical statisticians and clinical development teams.

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EVIDENCE-BASED MEDICINE

Real-World Evidence in Drug Development and Evaluation

Corrigan-Curay, Julia; Sacks, Leonard; Califf, Robert M.

Oxford University Press | 2025 | Hardcover | ISBN 9780198905127

This authoritative OUP volume examines the integration of real-world data and real-world evidence into regulatory decision-making for drugs and biologics. Topics include observational study design, data quality standards, propensity scoring, emulated trials, and the FDA's evolving framework for RWE acceptance. A key reference for health technology assessment professionals, regulatory scientists, and clinical researchers.

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ONCOLOGY TRIALS

Clinical Trial Design in Oncology: Modern Methods and Regulatory Considerations

Yin, Guosheng; Lam, K.F.

Springer | 2025 | Hardcover | ISBN 9783031502941

Focused on phase I–III oncology trial design, this Springer volume addresses dose-finding designs (CRM, BOIN, mTPI), survival endpoints, biomarker-stratified trials, and platform protocols including basket and umbrella designs. The book reflects current FDA and EMA thinking on immuno-oncology endpoints and accelerated approval pathways, making it essential reading for oncology clinical research professionals and academic trial centres.

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About CLNZ Books

CLNZ Books is a specialist academic and professional bookseller headquartered in Auckland, New Zealand — Bookseller for Professionals Worldwide. We curate titles across Law, Economics & Finance, Energy, and Medicine for university libraries, research institutions, hospital libraries, law faculties, and professional organisations globally.

Every title is personally selected. We work with leading publishers including Oxford University Press, Cambridge University Press, Springer, CRC Press, Routledge, Wiley, and Elsevier to ensure our catalogues reflect the most relevant and rigorous academic output.

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  • Institutional and library pricing available on request
  • Price includes worldwide shipping via DHL/FedEx
  • Purchase orders accepted from universities and institutions
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