Top

Published in:

Open Access 01-07-2016 | Short report

Statistical guidance for responsible data sharing: an overview

Authors: Christine Fletcher, Sally Hollis, Hans-Ulrich Burger, Christoph Gerlinger

Published in: BMC Medical Research Methodology | Special Issue 1/2016

Excerpt

Since at least 2004 there has been a focus on data sharing and clinical trial disclosure with the requirements for protocols to be registered in clinicaltrials.gov and for subsequent manuscripts of the study results to be accepted for publication by major journals [1]. However, sponsors of clinical trials have for many years been widely criticised for not adhering to these requirements and failing to disclose clinical trials in a timely fashion (e.g., www.alltrials.net]. …

Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors. International Committee of Medical Journal Editors. Sept 2004. http://www.icmje.org/news-and-editorials/clin_trial_sep2004.pdf [accessed 21 Aug 2015].

Principles for Responsible Clinical Trial Data Sharing. Our Commitment to Patients and Researchers. http://www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf [accessed 21 Aug 2015].

EFPIA Clinical Trial Data Portal Gateway http://transparency.efpia.eu/responsible-data-sharing/efpia-clinical-trial-data-portal-gateway [accessed 21 Aug 2015].

Clinical Trial Regulation – EU 536/2014. http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm [accessed 24 Aug 2015].

European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf [accessed 24 Aug 2015].

Publication of clinical data for medicinal products for human use. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf [accessed 24 Aug 2015].

International Clinical Trials Day – a day to celebrate. http://www.efpia.eu/mediaroom/262/43/International-Clinical-Trials-Day-a-day-to-celebrate [accessed 24 Aug 2015].

Fletcher C, on behalf of the EFSPI, et al. European Federation of Statisticians in the Pharmaceutical Industry’s position on access to clinical trial data. Pharm Stat. 2013;12:333–6.CrossRefPubMed

Sydes MR, Johnson AL, Meredith SK, Rauchenberger M, South A, Parmar MK. Sharing data from clinical trials: the rationale for a controlled access approach. Trials. 2015;16:104.CrossRefPubMedPubMedCentral

10.

Data De-identification and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach. TransCelerate BioPharma Inc. http://www.transceleratebiopharmainc.com/wp-content/uploads/2015/04/Data-Anonymization-Paper-FINAL-5.18.15.pdf [accessed 23 Oct 2015].

Title: Statistical guidance for responsible data sharing: an overview
Authors: Christine Fletcher
Sally Hollis
Hans-Ulrich Burger
Christoph Gerlinger
Publication date: 01-07-2016
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue Special Issue 1/2016
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/s12874-016-0168-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Statistical guidance for responsible data sharing: an overview

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

Please log in to get access to this content

Other articles of this Special Issue 1/2016

Data sharing and the evolving role of statisticians

Best practice for analysis of shared clinical trial data

EFSPI/PSI working group on data sharing: accessing and working with pharmaceutical clinical trial patient level datasets – a primer for academic researchers

Protecting patient privacy when sharing patient-level data from clinical trials