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A National Clinical Trial Audit System to Improve Clinical Trials Reporting

Research output: Other contribution

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A National Clinical Trial Audit System to Improve Clinical Trials Reporting. / HealthWatch UK; Universities Allied for Essential Medicines UK; TranspariMED ; Kolstoe, Simon.

6 p. Science and Technology Committee (Commons). 2017, Evidence to select committee.

Research output: Other contribution

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APA

Vancouver

HealthWatch UK, Universities Allied for Essential Medicines UK, TranspariMED, Kolstoe S. A National Clinical Trial Audit System to Improve Clinical Trials Reporting. 2017. 6 p.

Author

HealthWatch UK ; Universities Allied for Essential Medicines UK ; TranspariMED ; Kolstoe, Simon. / A National Clinical Trial Audit System to Improve Clinical Trials Reporting. 2017. Science and Technology Committee (Commons). 6 p.

Bibtex

@misc{db8a5917f1254737af652ed35285b1c7,
title = "A National Clinical Trial Audit System to Improve Clinical Trials Reporting",
abstract = "The incomplete and inaccurate reporting of clinical trials is a well-documented research integrity problem. Major factors contributing to this problem are the failure of trial sponsors and principal investigators to prospectively register all trials, post the summary results of all trials, and publish the outcomes of all trials in academic journals. This has negative consequences for UK patients, UK taxpayers, and UK investors, which are also well documented. Successive UK governments have failed to monitor compliance with, or sanction the violation of, national and European Union regulations intended to partially resolve the issue. As a result, compliance is weak. The persistence of the problem more than two decades after it was first recognized shows that individual action by stakeholders and unmonitored and unenforced regulations are insufficient to resolve it. A national clinical trial audit system would substantially strengthen research integrity in this field by monitoring the registration, summary results posting and academic publication of every trial conducted in the UK, benefiting UK patients, UK taxpayers, and UK investors. A pilot has proven the feasibility of setting up such a system in the UK. The system would cost little to set up and run. Its work would be based on records that already exist, and thus it would not generate any red tape, costs, or time delays for institutions conducting clinical trials in the UK. There is broad support within the UK medical research community for a national clinical trial audit system. The system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.",
keywords = "Transparency, Publication bias, Outcome reporting bias, Health Research Authority",
author = "{HealthWatch UK} and {Universities Allied for Essential Medicines UK} and TranspariMED and Simon Kolstoe",
year = "2017",
month = oct,
day = "17",
language = "English",
publisher = "Science and Technology Committee (Commons)",
type = "Other",

}

RIS

TY - GEN

T1 - A National Clinical Trial Audit System to Improve Clinical Trials Reporting

AU - HealthWatch UK

AU - Universities Allied for Essential Medicines UK

AU - TranspariMED

AU - Kolstoe, Simon

PY - 2017/10/17

Y1 - 2017/10/17

N2 - The incomplete and inaccurate reporting of clinical trials is a well-documented research integrity problem. Major factors contributing to this problem are the failure of trial sponsors and principal investigators to prospectively register all trials, post the summary results of all trials, and publish the outcomes of all trials in academic journals. This has negative consequences for UK patients, UK taxpayers, and UK investors, which are also well documented. Successive UK governments have failed to monitor compliance with, or sanction the violation of, national and European Union regulations intended to partially resolve the issue. As a result, compliance is weak. The persistence of the problem more than two decades after it was first recognized shows that individual action by stakeholders and unmonitored and unenforced regulations are insufficient to resolve it. A national clinical trial audit system would substantially strengthen research integrity in this field by monitoring the registration, summary results posting and academic publication of every trial conducted in the UK, benefiting UK patients, UK taxpayers, and UK investors. A pilot has proven the feasibility of setting up such a system in the UK. The system would cost little to set up and run. Its work would be based on records that already exist, and thus it would not generate any red tape, costs, or time delays for institutions conducting clinical trials in the UK. There is broad support within the UK medical research community for a national clinical trial audit system. The system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.

AB - The incomplete and inaccurate reporting of clinical trials is a well-documented research integrity problem. Major factors contributing to this problem are the failure of trial sponsors and principal investigators to prospectively register all trials, post the summary results of all trials, and publish the outcomes of all trials in academic journals. This has negative consequences for UK patients, UK taxpayers, and UK investors, which are also well documented. Successive UK governments have failed to monitor compliance with, or sanction the violation of, national and European Union regulations intended to partially resolve the issue. As a result, compliance is weak. The persistence of the problem more than two decades after it was first recognized shows that individual action by stakeholders and unmonitored and unenforced regulations are insufficient to resolve it. A national clinical trial audit system would substantially strengthen research integrity in this field by monitoring the registration, summary results posting and academic publication of every trial conducted in the UK, benefiting UK patients, UK taxpayers, and UK investors. A pilot has proven the feasibility of setting up such a system in the UK. The system would cost little to set up and run. Its work would be based on records that already exist, and thus it would not generate any red tape, costs, or time delays for institutions conducting clinical trials in the UK. There is broad support within the UK medical research community for a national clinical trial audit system. The system would provide Britain with a competitive advantage as a location for cutting edge clinical research and drug development.

KW - Transparency

KW - Publication bias

KW - Outcome reporting bias

KW - Health Research Authority

M3 - Other contribution

PB - Science and Technology Committee (Commons)

ER -

ID: 8003846