Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach

Hughes, Scott; Wells, Karen; McSorley, P.; Freeman, Andrew

doi:10.1002/pst.1615

Cited by 20 publications

(19 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Concerns about lack of anonymity are also common when requesting data from case-studies or case-series involving fewer than 50 participants, trials of rare diseases or trials assessing genomic data [52]. Thus, all data requires storage on secure password protected servers where access is provided only to those directly involved in data analysis according to available standards [52,[137][138][139].…”

Section: Confidentiality and Data Storagementioning

confidence: 99%

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

Ventresca

Macbeth

Clarke

et al. 2019

Preprint

View full text Add to dashboard Cite

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.

show abstract

Section: Confidentiality and Data Storagementioning

confidence: 99%

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

Ventresca

Macbeth

Clarke

et al. 2019

Preprint

View full text Add to dashboard Cite

show abstract

“…Many of the other concerns cannot be totally eliminated, but they can be mitigated and managed. For example, the development of algorithms for de-identification of patient data is becoming more sophisticated to protect patient privacy [22]. The concept of intellectual capital has been a bit more difficult to define and remains an issue.…”

Section: Issues With Data Access and Sharingmentioning

confidence: 99%

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

Rockhold

2017

Annals of Oncology

View full text Add to dashboard Cite

Calls for greater transparency and 'open data access' in clinical research are widespread, from sources including the Executive Office of the President, which in 2013 called for increased access to the results of federally funded research. In 2015, The Institute of Medicine issued a report advocating for a multi-stakeholder effort to foster responsible data sharing, and there are many others. Open science is good for researchers, good for innovation, and good for patients. The question at the center of the open-science efforts for clinical trials should not be whether data should be shared, but rather how we can usher in responsible methods for doing so. Unfortunately, there remain numerous perceived barriers to complete transparency around clinical trial data. This paper reviews the current status of data disclosure, the barriers to achieving it and a suggestion for the future.

show abstract

“…De‐identification of IPD includes the provision of a new code number to each trial participant that will replace the original code number and destroying the link between both codes; of note that any other data elements with personal information (e.g. investigators names, laboratory names, genetic data) are also removed to end up providing anonymized information . Similar standards of de‐identified IPD should be implemented for publicly funded trials: At the end of the trial, an anonymized data set must be prepared for sharing by the data custodian .…”

Section: How Data From Clinical Trials Are Recordedmentioning

confidence: 99%

The International Committee of Medical Journal Editors trial data sharing requirement and participants' consent

Dal‐Ré

2016

Eur J Clin Investigation

View full text Add to dashboard Cite

The International Committee of Medical Journal Editors (ICMJE) has published a draft proposal on de-identified individual clinical trial participant data (IPD) sharing, stating that sharing trial data requires planning to ensure appropriate research ethics committee approval and participants' informed consent. This is why its implementation will be deferred for 1 year after the publication of the final version of the policy. When conducting research with anonymous data, it is not feasible to obtain the informed consent from research participants. De-identified IPD are anonymous to the investigator who is performing the secondary analysis. De-identified IPD meta-analyses have been conducted for decades. Public funders, industry and foundations have recently implemented new IPD sharing procedures; almost all trials used for secondary analyses so far were conducted without participant's consent to de-identified IPD. As stated by the ICMJE, de-identified IPD protects participant's confidentiality. It follows that publishing secondary analyses from completed trials without participant's consent is ethically acceptable. From the ethical perspective, the ICMJE requirement on de-identified IPD sharing should be implemented from the day the policy is published.

show abstract

Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach

Cited by 20 publications

References 5 publications

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

Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

The International Committee of Medical Journal Editors trial data sharing requirement and participants' consent

Contact Info

Product

Resources

About