4.5 Article

Early phase clinical trials extension to guidelines for the content of statistical analysis plans

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Review Oncology

Randomised Phase 1 clinical trials in oncology

Alexia Iasonos et al.

Summary: Phase 1 trials in oncology have expanded their objectives from assessing tolerability to addressing multiple objectives under the heading of early-phase trials. The aim is to obtain reliable evidence of clinical activity for drug approvals. Designing a Phase 1 trial that can address multiple objectives is challenging and requires adherence to ethical and scientific principles.

BRITISH JOURNAL OF CANCER (2021)

Article Medicine, Research & Experimental

TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis

M. Cole et al.

Summary: TRAFIC is a multi-center early phase trial in rheumatoid arthritis using an adaptive model design, allowing borrowing of information from previous trials in Phase I and bringing efficiencies in Phase II. This trial demonstrates that small Phase I/II trials can have a statistical basis for decision-making and interpretation.

TRIALS (2021)

Article Medicine, General & Internal

Pilot early phase II study of decitabine and carboplatin in patients with advanced melanoma

Andre van der Westhuizen et al.

MEDICINE (2020)

Article Health Care Sciences & Services

How to design a dose-finding study using the continual reassessment method

Graham M. Wheeler et al.

BMC MEDICAL RESEARCH METHODOLOGY (2019)

Article Anesthesiology

Guide to the statistical analysis plan

Ian Yuan et al.

PEDIATRIC ANESTHESIA (2019)

Article Mathematical & Computational Biology

Using simulation studies to evaluate statistical methods

Tim P. Morris et al.

STATISTICS IN MEDICINE (2019)

Article Medicine, General & Internal

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

Carrol Gamble et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)

Article Oncology

Embracing model-based designs for dose-finding trials

Sharon B. Love et al.

BRITISH JOURNAL OF CANCER (2017)

Article Medicine, General & Internal

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

Sunita Vohra et al.

BMJ-BRITISH MEDICAL JOURNAL (2015)

Article Medicine, General & Internal

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

Sunita Vohra et al.

BMJ-BRITISH MEDICAL JOURNAL (2015)

Article Mathematical & Computational Biology

Dose-Finding Designs: The Role of Convergence Properties

Assaf P. Oron et al.

Article Medicine, General & Internal

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

Kenneth F. Schulz et al.

BMJ-BRITISH MEDICAL JOURNAL (2010)

Article Mathematical & Computational Biology

Critical aspects of the Bayesian approach to phase I cancer trials

Beat Neuenschwander et al.

STATISTICS IN MEDICINE (2008)

Article Medicine, General & Internal

Better reporting of harms in randomized trials: An extension of the CONSORT statement

JPA Ioannidis et al.

ANNALS OF INTERNAL MEDICINE (2004)