Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Key design considerations for adaptive clinical trials: a primer for clinicians

(2018) Kristian Thorlund et al.   BMJ-British Medical Journal

Key design considerations for adaptive clinical trials: a primer for clinicians

(2018) Kristian Thorlund et al.   BMJ-British Medical Journal

Critical concepts in adaptive clinical trials

(2018) Jay JH Park et al.   Clinical Epidemiology

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

(2017) Carrol Gamble et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Practical characteristics of adaptive design in phase 2 and 3 clinical trials

(2017) A. Sato et al.   JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS

Efficient design of clinical trials and epidemiological research: is it possible?

(2017) Michael S. Lauer et al.   Nature Reviews Cardiology

Estimands and Their Role in Clinical Trials

(2017) Mouna Akacha et al.   Statistics in Biopharmaceutical Research

The role of adaptive trial designs in drug development

(2017) François Curtin et al.   Expert Review of Clinical Pharmacology

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

(2016) Sunita Vohra et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Adaptive Clinical Trial Design: An Overview and Potential Applications in Dermatology

(2016) Scott A. Elman et al.   JOURNAL OF INVESTIGATIVE DERMATOLOGY

Estimands: discussion points from the PSI estimands and sensitivity expert group

(2016) Alan Phillips et al.   PHARMACEUTICAL STATISTICS

Estimands in clinical trials - broadening the perspective

(2016) Mouna Akacha et al.   STATISTICS IN MEDICINE

Preferred reporting of case series in surgery; the PROCESS guidelines

(2016) Riaz A. Agha et al.   International Journal of Surgery

Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls

(2015) Peter Bauer et al.   STATISTICS IN MEDICINE

CBER’s Experience With Adaptive Design Clinical Trials

(2015) Min Lin et al.   Therapeutic Innovation & Regulatory Science

An Investigation of the Shortcomings of the CONSORT 2010 Statement for the Reporting of Group Sequential Randomised Controlled Trials: A Methodological Systematic Review

(2015) Abigail Stevely et al.   PLoS One

Adaptive Clinical Trial Design

(2014) Shein-Chung Chow   Annual Review of Medicine

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

(2014) Ulrike Lorch et al.   BMC Medical Research Methodology

Defining consensus: A systematic review recommends methodologic criteria for reporting of Delphi studies

(2014) Ivan R. Diamond et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency

(2014) Amelie Elsäßer et al.   Trials

Adaptive Design

(2014) Caroline Claire Morgan et al.   Therapeutic Innovation & Regulatory Science

CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials

(2013) Kenneth F. Schulz   ANNALS OF INTERNAL MEDICINE

Uptake of novel statistical methods for early-phase clinical studies in the UK public sector

(2013) Thomas Jaki   Clinical Trials

Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force

(2013) Don Husereau et al.   VALUE IN HEALTH

Adaptive Clinical Trials

(2013) Jeff Maca et al.   Therapeutic Innovation & Regulatory Science

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

(2012) Christopher S Coffey et al.   Clinical Trials

Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development

(2012) Brenda Gaydos et al.   DRUG INFORMATION JOURNAL

Adaptive trial designs: a review of barriers and opportunities

(2012) John A Kairalla et al.   Trials

Benefits, challenges and obstacles of adaptive clinical trial designs

(2011) Shein-Chung Chow et al.   Orphanet Journal of Rare Diseases

Adaptive Methods: When and How Should They be Used in Clinical Trials?

(2011) Raphaël Porcher et al.   THERAPIE

Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development

(2010) Judith Quinlan et al.   Clinical Trials

Adaptive design clinical trials and trial logistics models in CNS drug development

(2010) Sue-Jane Wang et al.   EUROPEAN NEUROPSYCHOPHARMACOLOGY

FDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective

(2010) Christy Chuang-Stein et al.   Journal of Biopharmaceutical Statistics

Review of Draft FDA Adaptive Design Guidance

(2010) Thomas Cook et al.   Journal of Biopharmaceutical Statistics

Adaptive Designs for Randomized Trials in Public Health

(2009) C. Hendricks Brown et al.   Annual Review of Public Health

Adaptive designs for confirmatory clinical trials

(2009) Frank Bretz et al.   STATISTICS IN MEDICINE

CONSORT for reporting randomised trials in journal and conference abstracts

(2008) Sally Hopewell et al.   LANCET

Adaptive design methods in clinical trials – a review

(2008) Shein-Chung Chow et al.   Orphanet Journal of Rare Diseases

Adaptive Clinical Trials

(2008) Christopher S Coffey et al.   Drugs in research & development