Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010;14(8):iii. ix–xi, 1–193.
World Health Organization (WHO). WHO statement on public disclosure of clinical trial results. Geneva: WHO; 2015. Available from: http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1. Accessed 8th December 2015.
Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ. 2015;350:h2373.
Public Library of Science (PLOS). Data availability. San Francisco, CA: PLOS; 2015. Available from: http://journals.plos.org/plosmedicine/s/data-availability#loc-acceptable-data-sharing-methods. Accessed 8th December 2015.
Medical Research Council (MRC). MRC policy and guidance on sharing of research data from population and patient studies. Swindon: MRC; 2011. Available from: http://www.mrc.ac.uk/news-events/publications/mrc-policy-and-guidance-on-sharing-of-research-data-from-population-and-patient-studies/. Accessed 8th December 2015.
Research Councils UK (RCUK). Common principles on data policy. Swindon: RCUK; 2015. Available from: http://www.rcuk.ac.uk/research/datapolicy/. Accessed 8th December 2015.
Blanchard P, Bourhis J, Lacas B, Posner MR, Vermorken JB, Hernandez JJ, et al. Taxane-cisplatin-fluorouracil as induction chemotherapy in locally advanced head and neck cancers: an individual patient data meta-analysis of the meta-analysis of chemotherapy in head and neck cancer group. J Clin Oncol. 2013;31(23):2854–60.
Ying A, Arima H, Czernichow S, Woodward M, Huxley R, Turnbull F, et al. Effects of blood pressure lowering on cardiovascular risk according to baseline body-mass index: a meta-analysis of randomised trials. Lancet. 2015;385(9971):867–74.
Tudur Smith C, Marson AG, Chadwick DW, Williamson PR. Multiple treatment comparisons in epilepsy monotherapy trials. Trials. 2007;8(1):34.
Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials. Lancet. 2011;378(9793):771–84.
Riley RD, Price MJ, Jackson D, Wardle M, Gueyffier F, Wang J, et al. Multivariate meta-analysis using individual participant data. Res Synth Methods. 2015;6(2):157–74.
National Institute for Health and Clinical Excellence (NICE). The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. NICE clinical guideline CG137. London: NICE; 2012.
Tierney JF, Pignon JP, Gueffyier F, Clarke M, Askie L, Vale CL, et al. How individual participant data meta-analyses have influenced trial design, conduct, and analysis. J Clin Epidemiol. 2015;68(11):1325–35.
Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Med. 2012;9(4), e1001201.
Le Noury J, Nardo J, Healy D, Jureidini J, Raven M, Tufanaru C, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
Savage CJ, Vickers AJ. Empirical study of data sharing by authors publishing in PLoS journals. PLoS One. 2009;4(9), e7078.
Alsheikh-Ali AA, Qureshi W, Al-Mallah MH, Ioannidis JP. Public availability of published research data in high-impact journals. PLoS One. 2011;6(9), e24357.
Jaspers GJ, Degraeuwe PL. A failed attempt to conduct an individual patient data meta-analysis. Syst Rev. 2014;3:97.
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66.
European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA). Principles for responsible clinical trial data sharing. Brussels/Washington, DC: EFPIA/PhRMA; 2013. Available from: http://www.phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf. Accessed 8th December 2015.
Clinical Study Data Request. Available from: www.clinicalstudydatarequest.com.
European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. EMA/240810/2013. London: European Medicines Agency; 2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Accessed 8th December 2015.
Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: Institute of Medicine; 2015. Available from: http://iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx. Accessed 8th December 2015.
Berlin JA, Morris S, Rockhold F, Askie L, Ghersi D, Waldstreicher J. Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials. 2014;11:7–12.
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.
Hopkins C, Sydes M, Murray G, Woolfall K, Clarke M, Williamson P, et al. UK publicly-funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol. 2015. doi: 10.1016/j.jclinepi.2015.07.002. [Epub ahead of print]
Yale University Open Data Access (YODA) Project. Available from: http://yoda.yale.edu/.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
Health Research Authority. Consent and participant information. London: Health Research Authority; 2015. Available from: http://www.hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-and-participant-information/. Accessed 8th December 2015.
Scientific Data. Let’s be pragmatic about clinical data. Scientific Data. 2015;2:150034.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18.