Table 2.

Common Barriers to Data Sharing

Stakeholder Group	Barrier	Mitigation
Industry	(1) Access to data could identify new safety or efficacy concerns (2) Competitors gaining access to data	• Limiting use cases or analyses of data • Sharing placebo or control arm data only • Limiting access or use cases for data
Academic researchers	(1) Data may be published ahead of primary researcher publication	• Restricting publication timing • Limiting or delaying access to outside researchers • Requiring joint authorship for publications • Right to review publications
	(2) Non-experts may mis-interpret data (3) Desire to charge industry for access to data to support ongoing data collection	• Right to review publications • Engaging in collaborative development of tool based on contributed data • Limiting use of integrated data by stakeholder group • Control of use of data through a process of review • Data contribution as in-kind contribution to PPP/consortium for specific uses
Patients/patient groups	(5) Ability to retain connection with industry	• Referring all database users to patient group • Engaging patient groups on use of data for tool development as part of PPP
	(6) Data protections	• Demonstrating data security solutions
	(7) Patient privacy	• Limiting sharing to de-identified data • Implementing policies to prevent re-identification