Statistical shortcomings in licensing applications

J A Lewis; K M Facey

doi:10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U

Statistical shortcomings in licensing applications

Research output: Contribution to journal › Review article › peer-review

Abstract / Description of output

This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more arise from a poor understanding of areas of known statistical disagreement and from the unsatisfactory use of newer and more advanced techniques. Inadequacies in reporting statistical work are commonplace. Examples of all these shortcomings are provided and emphasis is placed on the value of a statistical contribution to overall summaries such as the clinical expert report.

Original language	English
Pages (from-to)	1663-73
Number of pages	11
Journal	STATISTICS IN MEDICINE
Volume	17
Issue number	15-16
DOIs	https://doi.org/10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U
Publication status	Published - 28 Sept 1998

Keywords / Materials (for Non-textual outputs)

Clinical Trials, Phase II as Topic/standards
Clinical Trials, Phase III as Topic/standards
Data Interpretation, Statistical
Dose-Response Relationship, Drug
Drug Approval
Europe
Guidelines as Topic
Humans
Licensure
Meta-Analysis as Topic
Regression Analysis
Reproducibility of Results
Research Design/standards

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10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U

Cite this

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title = "Statistical shortcomings in licensing applications",

abstract = "This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more arise from a poor understanding of areas of known statistical disagreement and from the unsatisfactory use of newer and more advanced techniques. Inadequacies in reporting statistical work are commonplace. Examples of all these shortcomings are provided and emphasis is placed on the value of a statistical contribution to overall summaries such as the clinical expert report.",

keywords = "Clinical Trials, Phase II as Topic/standards, Clinical Trials, Phase III as Topic/standards, Data Interpretation, Statistical, Dose-Response Relationship, Drug, Drug Approval, Europe, Guidelines as Topic, Humans, Licensure, Meta-Analysis as Topic, Regression Analysis, Reproducibility of Results, Research Design/standards",

author = "Lewis, {J A} and Facey, {K M}",

year = "1998",

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doi = "10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U",

language = "English",

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publisher = "John Wiley & Sons Inc.",

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T1 - Statistical shortcomings in licensing applications

AU - Lewis, J A

AU - Facey, K M

PY - 1998/9/28

Y1 - 1998/9/28

N2 - This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more arise from a poor understanding of areas of known statistical disagreement and from the unsatisfactory use of newer and more advanced techniques. Inadequacies in reporting statistical work are commonplace. Examples of all these shortcomings are provided and emphasis is placed on the value of a statistical contribution to overall summaries such as the clinical expert report.

AB - This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more arise from a poor understanding of areas of known statistical disagreement and from the unsatisfactory use of newer and more advanced techniques. Inadequacies in reporting statistical work are commonplace. Examples of all these shortcomings are provided and emphasis is placed on the value of a statistical contribution to overall summaries such as the clinical expert report.

KW - Clinical Trials, Phase II as Topic/standards

KW - Clinical Trials, Phase III as Topic/standards

KW - Data Interpretation, Statistical

KW - Dose-Response Relationship, Drug

KW - Drug Approval

KW - Europe

KW - Guidelines as Topic

KW - Humans

KW - Licensure

KW - Meta-Analysis as Topic

KW - Regression Analysis

KW - Reproducibility of Results

KW - Research Design/standards

U2 - 10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U

DO - 10.1002/(SICI)1097-0258(19980815/30)17:15/16<1663::AID-SIM969>3.0.CO;2-U

M3 - Review article

C2 - 9749438

SN - 0277-6715

VL - 17

SP - 1663

EP - 1673

JO - STATISTICS IN MEDICINE

JF - STATISTICS IN MEDICINE

IS - 15-16

ER -

Statistical shortcomings in licensing applications

Abstract / Description of output

Keywords / Materials (for Non-textual outputs)

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