4.2 Article

Optimal unplanned design modification in adaptive two-stage trials

Related references

Note: Only part of the references are listed.
Article Mathematical & Computational Biology

Optimal planning of adaptive two-stage designs

Maximilian Pilz et al.

Summary: The study demonstrates that optimal adaptive designs can bring significant benefits in clinical trial planning. By customizing the underlying optimization problem, optimal designs can be tailored to specific operational requirements for an almost negligible performance loss compared to conventional designs.

STATISTICS IN MEDICINE (2021)

Article Computer Science, Interdisciplinary Applications

The adoptr Package: Adaptive Optimal Designs for Clinical Trials in R

Kevin Kunzmann et al.

Summary: Adoptr is a statistical software for adaptive two-stage trial designs, particularly for two-arm trials with normally distributed outcomes. Unlike previous approaches, adoptr optimizes the design upfront, aiming for maximum efficiency. It allows users to specify different objective functions flexibly, and provides measures to assist practitioners in the validation process.

JOURNAL OF STATISTICAL SOFTWARE (2021)

Article Pharmacology & Pharmacy

Optimal adaptive single-arm phase II trials under quantified uncertainty

Kevin Kunzmann et al.

JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2020)

Article Mathematical & Computational Biology

A new conditional performance score for the evaluation of adaptive group sequential designs with sample size recalculation

Carolin Herrmann et al.

STATISTICS IN MEDICINE (2020)

Article Mathematical & Computational Biology

A variational approach to optimal two-stage designs

Maximilian Pilz et al.

STATISTICS IN MEDICINE (2019)

Article Pharmacology & Pharmacy

Better decision making in drug development through adoption of formal prior elicitation

Nigel Dallow et al.

PHARMACEUTICAL STATISTICS (2018)

Article Mathematical & Computational Biology

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

Peter Bauer et al.

STATISTICS IN MEDICINE (2016)

Article Mathematical & Computational Biology

Adaptive sample size modification in clinical trials: start small then ask for more?

Christopher Jennison et al.

STATISTICS IN MEDICINE (2015)

Article Mathematical & Computational Biology

Methods for proper handling of overrunning and underrunning in phase II designs for oncology trials

Stefan Englert et al.

STATISTICS IN MEDICINE (2015)

Article Mathematical & Computational Biology

Sample Size Re-estimation Designs In Confirmatory Clinical Trials-Current State, Statistical Considerations, and Practical Guidance

Yili L. Pritchett et al.

STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2015)

Article Mathematical & Computational Biology

Unplanned adaptations before breaking the blind

Martin Posch et al.

STATISTICS IN MEDICINE (2012)

Article Pharmacology & Pharmacy

The perils with the misuse of predictive power

Nigel Dallow et al.

PHARMACEUTICAL STATISTICS (2011)

Article Mathematical & Computational Biology

Adaptive designs: Looking for a needle in the haystack - A new challenge in medical research

Peter Bauer

STATISTICS IN MEDICINE (2008)

Article Mathematical & Computational Biology

Bayesian predictive approach to interim monitoring in clinical trials

A Dmitrienko et al.

STATISTICS IN MEDICINE (2006)

Article Mathematical & Computational Biology

The reassessment of trial perspectives from interim data - a critical view

P Bauer et al.

STATISTICS IN MEDICINE (2006)

Article Pharmacology & Pharmacy

Assurance in clinical trial design

A O'Hagan et al.

PHARMACEUTICAL STATISTICS (2005)

Article Mathematical & Computational Biology

A general statistical principle for changing a design any time during the course of a trial

HH Müller et al.

STATISTICS IN MEDICINE (2004)

Article Mathematical & Computational Biology

Mid-course sample size modification in clinical trials based on the observed treatment effect

C Jennison et al.

STATISTICS IN MEDICINE (2003)

Article Biology

Optimal asymmetric one-sided group sequential tests

S Barber et al.

BIOMETRIKA (2002)