4.8 Article

Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

Related references

Note: Only part of the references are listed.
Article Health Care Sciences & Services

Expected Value of Sample Information to Guide the Design of Group Sequential Clinical Trials

Laura Flight et al.

Summary: This study introduces the incorporation of health economic considerations into adaptive trial designs and demonstrates how to estimate the expected value of sample information and expected net benefit through a case study. Results indicate that the O'Brien-Fleming stopping rule with 2 analyses was the most efficient design in the case study.

MEDICAL DECISION MAKING (2022)

Article Medicine, General & Internal

Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project

Nina Wilson et al.

Summary: Adaptive designs generally require slightly more resources compared to non-adaptive trials, with the increase mostly seen in the need for statistical staff. Factors influencing resource increases include experience with adaptive trials, design complexity, and funding for core infrastructure within the CTU.

BMC MEDICINE (2021)

Article Economics

Content of Health Economics Analysis Plans (HEAPs) for Trial-Based Economic Evaluations: Expert Delphi Consensus Survey

Joanna C. Thorn et al.

Summary: Through expert consensus, this study identified 58 essential items in a Health Economics Analysis Plan (HEAP) that can provide guidance for economic evaluations.

VALUE IN HEALTH (2021)

Article Economics

Can adaptive clinical trials help to solve the productivity crisis of the pharmaceutical industry?-a scenario analysis

Joerg Mahlich et al.

Summary: Implementing adaptive trial designs to increase clinical trial success rates can significantly reduce drug development costs, freeing up additional funds for pharmaceutical R&D and potentially generating millions of life-years.

HEALTH ECONOMICS REVIEW (2021)

Review Health Care Sciences & Services

A scoping review shows that several nonvalidated budget planning tools for randomized trials are available

Benjamin Speich et al.

JOURNAL OF CLINICAL EPIDEMIOLOGY (2020)

Article Oncology

Effective delivery of Complex Innovative Design (CID) cancer trials-A consensus statement

Sarah P. Blagden et al.

BRITISH JOURNAL OF CANCER (2020)

Review Health Care Sciences & Services

An overview of platform trials with a checklist for clinical readers

Jay J. H. Park et al.

JOURNAL OF CLINICAL EPIDEMIOLOGY (2020)

Article Medicine, General & Internal

When to keep it simple - adaptive designs are not always useful

James M. S. Wason et al.

BMC MEDICINE (2019)

Review Medicine, Research & Experimental

Conducting clinical trials-costs, impacts, and the value of clinical trials networks: A scoping review

Colene Bentley et al.

CLINICAL TRIALS (2019)

Article Medicine, General & Internal

Adaptive designs in clinical trials: why use them, and how to run and report them

Philip Pallmann et al.

BMC MEDICINE (2018)

Review Health Care Sciences & Services

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data

Benjamin Speich et al.

JOURNAL OF CLINICAL EPIDEMIOLOGY (2018)

Article Medicine, General & Internal

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

Kristian Thorlund et al.

BMJ-BRITISH MEDICAL JOURNAL (2018)

Article Medicine, General & Internal

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

Kristian Thorlund et al.

BMJ-BRITISH MEDICAL JOURNAL (2018)

Article Pharmacology & Pharmacy

Response-adaptive clinical trials: case studies in the medical literature

Andrew P. Grieve

PHARMACEUTICAL STATISTICS (2017)

Article Health Care Sciences & Services

A multi-stage drop-the-losers design for multi-arm clinical trials

James Wason et al.

STATISTICAL METHODS IN MEDICAL RESEARCH (2017)

Article Statistics & Probability

A Bayesian decision theoretic model of sequential experimentation with delayed response

Stephen Chick et al.

JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES B-STATISTICAL METHODOLOGY (2017)

Editorial Material Biotechnology & Applied Microbiology

How much do clinical trials cost?

Linda Martin et al.

NATURE REVIEWS DRUG DISCOVERY (2017)

Article Economics

Innovation in the pharmaceutical industry: New estimates of R&D costs

Joseph A. DiMasi et al.

JOURNAL OF HEALTH ECONOMICS (2016)

Article Health Care Sciences & Services

USE OF VALUE OF INFORMATION IN UK HEALTH TECHNOLOGY ASSESSMENTS

Syed Mohiuddin et al.

INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE (2014)

Article Mathematical & Computational Biology

A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials

James M. S. Wason et al.

STATISTICS IN MEDICINE (2014)

Article Medicine, Research & Experimental

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

Thomas Jaki

CLINICAL TRIALS (2013)

Article Mathematical & Computational Biology

Optimal design of multi-arm multi-stage trials

James M. S. Wason et al.

STATISTICS IN MEDICINE (2012)

Article Mathematical & Computational Biology

Exploring the benefits of adaptive sequential designs in time-to-event endpoint settings

Sarah C. Emerson et al.

STATISTICS IN MEDICINE (2011)

Article Pharmacology & Pharmacy

Operational challenges in adaptive design implementation

P Gallo

PHARMACEUTICAL STATISTICS (2006)

Article Health Care Sciences & Services

Confidentiality and trial integrity issues for adaptive designs

Paul Gallo

DRUG INFORMATION JOURNAL (2006)

Article Medicine, General & Internal

Statistics Notes - Blinding in clinical trials and other studies

SJ Day et al.

BRITISH MEDICAL JOURNAL (2000)