Value and usability of unpublished data sources for systematic reviews and network meta-analyses
Value and usability of unpublished data sources for systematic reviews and network meta-analyses
Peer-reviewed publications and conference proceedings are the mainstay of data sources for systematic reviews and network meta-analyses (NMA), but access to informative unpublished data is now becoming commonplace. To explore the usefulness of three types of 'grey' literature-clinical trials registries, clinical study reports and data from regulatory authorities-we conducted four case studies. The reporting of outcome data in peer-reviewed publications, the clinical trials registries and the clinical study reports for two clinical trials-one in melanoma, one in juvenile idiopathic arthritis (JIA)-was examined. In addition, we assessed the value of including unpublished data from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in evidence syntheses of hepatitis C virus (HCV) and chronic obstructive pulmonary disease (COPD), respectively. For the clinical trials in melanoma and JIA, we identified outcome parameters on ClinicalTrials.gov additional to those reported in the peer-reviewed publications: subgroup data and additional efficacy end points/extended follow-up, respectively. The clinical study report also provided results for several subgroups unavailable elsewhere. For HCV and COPD, additional outcome data were obtained from the EMA European Public Assessment Report (EPAR) and the FDA, respectively, including data on subgroups and mortality. We conclude that data from these grey literature sources have the potential to influence results of systematic reviews and NMAs, and may thus have implications for healthcare decisions. However, it is important to consider carefully the availability, reliability and consequent usability of these data sources in systematic reviews and NMAs.
Clinical Trials as Topic, Humans, Information Storage and Retrieval, Meta-Analysis as Topic, Network Meta-Analysis, Publications, Registries, Reproducibility of Results, Review Literature as Topic, United States, United States Food and Drug Administration
208-213
Halfpenny, Nicholas James Anthony
4f36586d-89d9-45d5-a1e1-e350629f483c
Quigley, Joan Mary
e2b25ca1-237d-408a-be88-81d3e8602e79
Thompson, Juliette Catherine
1ede95c4-c110-425a-908b-29c7ebb81216
Scott, David Alexander
19b5fd34-9974-4ae4-8be0-27a693639e20
December 2016
Halfpenny, Nicholas James Anthony
4f36586d-89d9-45d5-a1e1-e350629f483c
Quigley, Joan Mary
e2b25ca1-237d-408a-be88-81d3e8602e79
Thompson, Juliette Catherine
1ede95c4-c110-425a-908b-29c7ebb81216
Scott, David Alexander
19b5fd34-9974-4ae4-8be0-27a693639e20
Halfpenny, Nicholas James Anthony, Quigley, Joan Mary, Thompson, Juliette Catherine and Scott, David Alexander
(2016)
Value and usability of unpublished data sources for systematic reviews and network meta-analyses.
Evidence-Based Medicine, 21 (6), .
(doi:10.1136/ebmed-2016-110494).
Abstract
Peer-reviewed publications and conference proceedings are the mainstay of data sources for systematic reviews and network meta-analyses (NMA), but access to informative unpublished data is now becoming commonplace. To explore the usefulness of three types of 'grey' literature-clinical trials registries, clinical study reports and data from regulatory authorities-we conducted four case studies. The reporting of outcome data in peer-reviewed publications, the clinical trials registries and the clinical study reports for two clinical trials-one in melanoma, one in juvenile idiopathic arthritis (JIA)-was examined. In addition, we assessed the value of including unpublished data from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in evidence syntheses of hepatitis C virus (HCV) and chronic obstructive pulmonary disease (COPD), respectively. For the clinical trials in melanoma and JIA, we identified outcome parameters on ClinicalTrials.gov additional to those reported in the peer-reviewed publications: subgroup data and additional efficacy end points/extended follow-up, respectively. The clinical study report also provided results for several subgroups unavailable elsewhere. For HCV and COPD, additional outcome data were obtained from the EMA European Public Assessment Report (EPAR) and the FDA, respectively, including data on subgroups and mortality. We conclude that data from these grey literature sources have the potential to influence results of systematic reviews and NMAs, and may thus have implications for healthcare decisions. However, it is important to consider carefully the availability, reliability and consequent usability of these data sources in systematic reviews and NMAs.
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e-pub ahead of print date: 29 September 2016
Published date: December 2016
Keywords:
Clinical Trials as Topic, Humans, Information Storage and Retrieval, Meta-Analysis as Topic, Network Meta-Analysis, Publications, Registries, Reproducibility of Results, Review Literature as Topic, United States, United States Food and Drug Administration
Identifiers
Local EPrints ID: 440867
URI: http://eprints.soton.ac.uk/id/eprint/440867
ISSN: 1356-5524
PURE UUID: a340ea4a-ca51-4db6-ae0e-edcf8f0e1035
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Date deposited: 21 May 2020 16:30
Last modified: 17 Mar 2024 04:02
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Author:
Nicholas James Anthony Halfpenny
Author:
Joan Mary Quigley
Author:
Juliette Catherine Thompson
Author:
David Alexander Scott
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