title: Protecting patient privacy when sharing patient-level data from clinical trials.
abstract: BACKGROUND
  Greater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies. A concern remains, however, over how to appropriately prepare and share clinical trial data with third party researchers, whilst maintaining patient confidentiality. Clinical trial datasets contain very detailed information on each participant. Risk to patient privacy can be mitigated by data reduction techniques. However, retention of data utility is important in order to allow meaningful scientific research. In addition, for clinical trial data, an excessive application of such techniques may pose a public health risk if misleading results are produced. After considering existing guidance, this article makes recommendations with the aim of promoting an approach that balances data utility and privacy risk and is applicable across clinical trial data holders.
  
  
  CONCLUSIONS
  Our key recommendations are as follows: 1. Data anonymisation/de-identification: Data holders are responsible for generating de-identified datasets which are intended to offer increased protection for patient privacy through masking or generalisation of direct and some indirect identifiers. 2. Controlled access to data, including use of a data sharing agreement: A legally binding data sharing agreement should be in place, including agreements not to download or further share data and not to attempt to seek to identify patients. Appropriate levels of security should be used for transferring data or providing access; one solution is use of a secure 'locked box' system which provides additional safeguards. This article provides recommendations on best practices to de-identify/anonymise clinical trial data for sharing with third-party researchers, as well as controlled access to data and data sharing agreements. The recommendations are applicable to all clinical trial data holders. Further work will be needed to identify and evaluate competing possibilities as regulations, attitudes to risk and technologies evolve.
authors.affiliation: Roche Products Ltd, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK. katherine.tucker@roche.com.
authors.forename: Katherine
authors.initials: K
authors.lastname: Tucker
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Janice
authors.initials: J
authors.lastname: Branson
authors.affiliation: Pfizer Ltd, Walton Oaks, Dorking Road, Walton-on-the-Hill, Tadworth, Surrey, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Dilleen
authors.affiliation: AstraZeneca, Alderley Park, Cheshire, Macclesfield, SK10 4TG, UK.|Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester Academic Health Science Centre, Oxford Road, Manchester, M13 9PL, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Hollis
authors.affiliation: AstraZeneca, Alderley Park, Cheshire, Macclesfield, SK10 4TG, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Loughlin
authors.affiliation: Chilli Consultancy Ltd, Aldwych House, Winchester Street, Andover, Hampshire, SP10 2EA, UK.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Nixon
authors.affiliation: LEO Pharma, Horizon, Honey Lane, Hurley, SL6 6RJ, UK.
authors.forename: Zoë
authors.initials: Z
authors.lastname: Williams
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003219:Confidentiality; D004345:Drug Industry; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence; D018907:Privacy / Q000331:legislation & jurisprudence
keywords: Anonymisation; Clinical trial; Data sharing; De-identification; Pharmaceutical research; Transparency