Table 3.

Results of review of 10 key prominent data sharing guidelines and how the Good Pharma Scorecard data sharing measures compared with reviewed guidelines

Standards	Good Pharma Scorecard	Institute of Medicine report	PhRMA & EFPIA guidelines
When?	Six months after FDA approval, six months after marketing approval by European Medicines Agency, or 18 months after trial completion date, whichever is latest	30 days after approval, 18 months after trial completion date, or six months after publication, whichever is latest	Within a reasonable period after drug approval
Included trials	Phase II or III trials in a successful new drug application	Clinical trials initiated after 14 January 2015	Patient trials in United States and European Union drug submissions approved after 1 January 2014
Excluded trials	• Phase I trials       • Expanded access trials       • Trials terminated without enrollment       • Trials for indications other than those approved by FDA       • Trials with a high risk of re-identification (if requested)	Trials with a high risk of re-identification	Trials with a high risk of re-identification
Which data?	Trial is registered       Company’s data sharing policy provides access to: analysis ready dataset and CSR or all of the following:                   • Statistical analysis plan                   • Study protocol                   • Dataset codebook                   • CSR synopsis       Company’s policy explains how data can be requested       Company reports annually the number of data requests it received and how they are handled (approved/rejected)	Analysis ready dataset       All the following metadata:         • CSR         • Statistical analysis plan         • Study protocol         • Analytic code	Analysis ready dataset      All the following metadata:         • CSR         • Study protocol

FDA=Food and Drug Administration; CSR=clinical study report; PhRMA=Pharmaceutical Research and Manufacturers of America; EFPIA= European Federation of Pharmaceutical Industries and Associations.