Retrieval of individual patient data depended on study characteristics: a randomized controlled trial

Veroniki, Areti Angeliki; Ashoor, Huda; Le, Susan P.C.; Rios, Patricia; Stewart, Lesley; Clarke, Mike; Mavridis, Dimitris; Straus, Sharon E.; Tricco, Andrea C.

doi:10.1016/j.jclinepi.2019.05.031

Cited by 29 publications

(38 citation statements)

References 40 publications

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“…Additionally, we did not request IPD from investigators of trials for which we had access to summary level data. IPD are commonly not made available for small, investigator initiated trials more than a decade old that are probably in older formats 75. Although we contacted corresponding authors to clarify potential uncertainties, failure to mention a particular outcome does not necessarily imply that there were no such events in the study 37.…”

Section: Discussionmentioning

confidence: 99%

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses

Wallach

Wang

Zhang

et al. 2020

BMJ

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WhAt is AlreAdy knoWn on this topicSince 2007, several meta-analyses have been conducted that have used various analytic approaches and reported conflicting findings about the cardiovascular risk of rosiglitazone Previous meta-analyses did not have access to individual patient level data (IPD) from clinical trials and mostly relied on summary level data Little consensus exists on which method should be used to account for sparse adverse event data in meta-analyses WhAt this study AddsAmong trials for which IPD were available, rosiglitazone use was consistently associated with an increased cardiovascular risk, especially for heart failure events Increased myocardial infarction risk was observed across analyses, but the magnitudes of risk varied and were attenuated when summary level data were used in addition to IPD Among trials for which IPD were available, more myocardial infarctions and fewer cardiovascular deaths were reported in IPD compared with summary level data on 9 June 2020 by guest. Protected by copyright.

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Section: Discussionmentioning

confidence: 99%

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses

Wallach

Wang

Zhang

et al. 2020

BMJ

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“…drafting a data sharing agreement, converting old datasets to digital format) for the primary study author and attempt to establish a personal connection would be more likely to receive a response [136]. IPDMA authors typically attempt contact several times before quitting; the most persistent tried every 6 months for 2 to 3 years [130,131,136,137]. From our own experience, obtaining data sets through personal contact required as little as 4 months and as much as 4 years.…”

Section: Requesting Study Data Through Personal Contactmentioning

confidence: 99%

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

Ventresca

Schünemann

Macbeth

et al. 2020

BMC Med Res Methodol

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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.

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“…Qualitative research examining useful techniques to obtain unpublished data indicates that polite requests which minimize additional responsibilities for the primary study author would be more likely to receive a response [82]. IPDMA authors typically attempt contact several times before quitting; the most persistent tried every 6 months for two to three years [80,[82][83][84]. From our own experience, obtaining data sets through personal contact may take between approximately four months and four years.…”

Section: Requesting Study Data Through Personal Contactmentioning

confidence: 99%

“…shipping fees) but did not offer direct payment solely for sharing data which was also not requested by any of the collaborating parties. Offering small financial incentives to primary study authors has not improved IPD retrieval rates [84].…”

Section: Incentives For Data Contributorsmentioning

confidence: 99%

“…Many sponsors have recognized this impediment and changed their participant consent forms accordingly [52] 25,49,106,107,[119][120][121][122][123][124][125]. Some argued that older trials require excessive time and resources to properly anonymize IPD, update databases to current standard or transfer data to an electronic format, assuming they have not been lost [15,84]. Sharing of databases may be refused because datasets are too large to properly anonymize and transfer to other researchers [52,126].…”

Section: Time To Data Retrieval and Reasons For Refused Requestsmentioning

confidence: 99%

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Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

Ventresca

Macbeth

Clarke

et al. 2019

Preprint

Self Cite

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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 based on a review of the literature and practical examples and observations. Methods We systematically searched MEDLINE, Embase, and the Cochrane Library 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 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 study authors or data sharing administrators and should offer assistance in readying data for sharing.

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Retrieval of individual patient data depended on study characteristics: a randomized controlled trial

Cited by 29 publications

References 40 publications

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses

Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide

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