Obtaining real-world evidence: the Salford Lung Study.

John P New; Nawar Diar Bakerly; David Leather; Ashley Woodcock

doi:10.1136/thoraxjnl-2014-205259

Obtaining real-world evidence: the Salford Lung Study.

John P New, Nawar Diar Bakerly, David Leather, Ashley Woodcock

Research output: Contribution to journal › Article › peer-review

Abstract

UNLABELLED: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention. GLAXOSMITHKLINE PROTOCOL: HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.

Original language	English
Journal	Thorax
Volume	69
Issue number	12
DOIs	https://doi.org/10.1136/thoraxjnl-2014-205259
Publication status	Published - Dec 2014

Keywords

Asthma
COPD Exacerbations

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/thoraxjnl-2014-205259

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title = "Obtaining real-world evidence: the Salford Lung Study.",

abstract = "UNLABELLED: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention. GLAXOSMITHKLINE PROTOCOL: HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.",

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author = "New, {John P} and Bakerly, {Nawar Diar} and David Leather and Ashley Woodcock",

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AU - New, John P

AU - Bakerly, Nawar Diar

AU - Leather, David

AU - Woodcock, Ashley

PY - 2014/12

Y1 - 2014/12

N2 - UNLABELLED: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention. GLAXOSMITHKLINE PROTOCOL: HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.

AB - UNLABELLED: We need to assess clinical treatments in real-life settings outside of randomised controlled trials (RCTs). Pragmatic RCT (pRCT) data can supplement RCTs by providing effectiveness information to support healthcare decisions. Electronic health records can facilitate concurrent safety monitoring and data collection without direct patient contact for large randomised study populations in pRCTs. The Salford Lung Study is the world's first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomise over 7000 patients. This paper describes the hurdles overcome and the enormous effort and resource required to establish this comparative effectiveness study of a prelicence intervention. GLAXOSMITHKLINE PROTOCOL: HZC115151 ASTHMA STUDY CLINICALTRIALSGOV REGISTRATION: NCT01706198 COPD STUDY CLINICALTRIALSGOV REGISTRATION: NCT01551758.

KW - Asthma

KW - COPD Exacerbations

U2 - 10.1136/thoraxjnl-2014-205259

DO - 10.1136/thoraxjnl-2014-205259

M3 - Article

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JO - Thorax

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Obtaining real-world evidence: the Salford Lung Study.

Abstract

Keywords

UN SDGs

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