Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide
Abstract Background Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the cha...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-05-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | http://link.springer.com/article/10.1186/s12874-020-00964-6 |
| _version_ | 1818061202419351552 |
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| author | Matthew Ventresca Holger J. Schünemann Fergus Macbeth Mike Clarke Lehana Thabane Gareth Griffiths Simon Noble David Garcia Maura Marcucci Alfonso Iorio Qi Zhou Mark Crowther Elie A. Akl Gary H. Lyman Viktoria Gloy Marcello DiNisio Matthias Briel |
| author_facet | Matthew Ventresca Holger J. Schünemann Fergus Macbeth Mike Clarke Lehana Thabane Gareth Griffiths Simon Noble David Garcia Maura Marcucci Alfonso Iorio Qi Zhou Mark Crowther Elie A. Akl Gary H. Lyman Viktoria Gloy Marcello DiNisio Matthias Briel |
| author_sort | Matthew Ventresca |
| collection | DOAJ |
| description | Abstract Background Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD. Results Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues. Conclusions Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing. |
| first_indexed | 2024-12-10T13:44:34Z |
| format | Article |
| id | doaj.art-0650f0bba5ab4194bb8f44724b051960 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-10T13:44:34Z |
| publishDate | 2020-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-0650f0bba5ab4194bb8f44724b0519602022-12-22T01:46:29ZengBMCBMC Medical Research Methodology1471-22882020-05-0120111810.1186/s12874-020-00964-6Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guideMatthew Ventresca0Holger J. Schünemann1Fergus Macbeth2Mike Clarke3Lehana Thabane4Gareth Griffiths5Simon Noble6David Garcia7Maura Marcucci8Alfonso Iorio9Qi Zhou10Mark Crowther11Elie A. Akl12Gary H. Lyman13Viktoria Gloy14Marcello DiNisio15Matthias Briel16Department of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityCentre for Trials Research, School of Medicine, Cardiff UniversityNorthern Ireland Hub for Trials Methodology Research and Cochrane Individual Participant Data Meta-analysis Methods Group, Queen’s University BelfastDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityWales Cancer Trials Unit, School of Medicine, Cardiff University, Wales, UK; Faculty of Medicine, University of SouthamptonMarie Curie Palliative Care Research Centre, Cardiff UniversityDepartment of Medicine, University of Washington School of MedicineDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Medicine, McMaster UniversityDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDepartment of Medicine, University of Washington School of MedicineBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital BaselDepartment of Medicine and Ageing Sciences, University G. D’AnnunzioDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityAbstract Background Shifts in data sharing policy have increased researchers’ access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD. Results Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues. Conclusions Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.http://link.springer.com/article/10.1186/s12874-020-00964-6Individual participant data meta-analysisData collectionData sharingSystematic reviewPractical guide |
| spellingShingle | Matthew Ventresca Holger J. Schünemann Fergus Macbeth Mike Clarke Lehana Thabane Gareth Griffiths Simon Noble David Garcia Maura Marcucci Alfonso Iorio Qi Zhou Mark Crowther Elie A. Akl Gary H. Lyman Viktoria Gloy Marcello DiNisio Matthias Briel Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide BMC Medical Research Methodology Individual participant data meta-analysis Data collection Data sharing Systematic review Practical guide |
| title | Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide |
| title_full | Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide |
| title_fullStr | Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide |
| title_full_unstemmed | Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide |
| title_short | Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide |
| title_sort | obtaining and managing data sets for individual participant data meta analysis scoping review and practical guide |
| topic | Individual participant data meta-analysis Data collection Data sharing Systematic review Practical guide |
| url | http://link.springer.com/article/10.1186/s12874-020-00964-6 |
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