PCORI Open Science Pilot Project: Facilitating Data Sharing through - PowerPoint PPT Presentation

ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA PCORI Open Science Pilot Project: Facilitating Data Sharing through Harmonized Governance Tools Rebecca Li, Ph.D. Senior Advisor, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Executive Director, Vivli November 1, 2017 #PCORI2017

ANNUAL MEETING | #PCORI2017 Rebecca Li, Ph.D. • Has nothing to disclose. Organizati tion L Logo go Here re (150 dpi resolution jpg or png file) November 5, 2017 2

ANNUAL MEETING | #PCORI2017 Objectives • Summarize MRCT Center’s efforts and commitments to data sharing and data transparency • Outline MRCT Center’s involvement in PCORI Open Science Pilot Project • Role: to define and address key governance issues related to data deposition in repositories and data sharing • Review the 3 governance tools that MRCT Center will develop as part of the PCORI Open Science Pilot Project • Data Contributor Agreement Template (DCA) • Data Use Agreement Template (DUA) • Data Sharing Section of Informed Consent Form (ICF) November 5, 2017 3

ANNUAL MEETING | #PCORI2017 MRCT Center Overview • We engage diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions. Non profits Journal Industry editors Patients and Gov’t Patient Org Academia November 5, 2017 4

ANNUAL MEETING | #PCORI2017 Our Focus Areas Global Ethical Data Training Regulatory Frameworks Transparency November 5, 2017 5

ANNUAL MEETING | #PCORI2017 MRCT’s 3-Tiered Commitment to Data Transparency November 5, 2017 6

ANNUAL MEETING | #PCORI2017 MRCT’s Past Data Sharing Efforts November 5, 2017 7

ANNUAL MEETING | #PCORI2017 MRCT’s Role in Open Science Pilot Project • To deliver three harmonized governance tools (DUA, DCA, ICF) that will be made publicly available for all 1 PCORI grantees • To lower the barriers to data sharing while preserving participant privacy and autonomy 2 • To respect interests of data generators, data users, funders, and patients/ participants through multi- 3 stakeholder engagement November 5, 2017 8

ANNUAL MEETING | #PCORI2017 Harmonized Governance Tools: High-Level Development Plan { RADCOMP team DCA, DUA, ICF PCORI- Template assigned DCA teams CODA team DCA, DUA, ICF Final DCA, DUA, and Template DUA ICF Other Pilot Templates Project teams’ DCA, DUA, ICF Template ICF MRCT DCA, DUA, ICF November 5, 2017 9

ANNUAL MEETING | #PCORI2017 Harmonized Governance Tools: Communication and Iterative Development • MRCT Center hosts bi-weekly calls with our assigned Open Science Pilot Project teams (RADCOMP and CODA) to discuss considerations for the harmonized governance tools • MRCT Center circulates finalized documents to larger Open Science Pilot Project group for feedback as part of iterative review process November 5, 2017 10

ANNUAL MEETING | #PCORI2017 Progress to Date • Governance Tools working group launched on September 11, 2017; regularly meets every 2 weeks • Drafted and circulated considerations document for DCA, DUA, ICF • Drafted and circulated Data Use Agreement v.1.0 • Initiated discussion toward DUA version 1.1 • Data Contributor Agreement v.1.0 in progress • Initiated contact with patient advocacy representatives re: plain language data sharing section of ICF • Examples of governance considerations discussed to date: • Whether requesters or institutions should be signee of DUA • Publication, citation, and summary results requirements • Commercial and litigious use of requested datasets • Intellectual property, licensing, and ownership of datasets and secondary analyses • Obligations and responsibilities of data contributors, repositories, and data requesters November 5, 2017 11

ANNUAL MEETING | #PCORI2017 Considerations for DCA • Agreement to deposition of data package elements to repository • Description of data deposition requirements • PCORI-defined requirements, data format requirements, dataset size/ number of records • Description of repository’s hosting services and responsibilities • Description of data contributor responsibilities • Anonymization/ de-identification requirements • Statement re: data ownership • Permission to host data for intended re-use; permission to disseminate data for approved purposes November 5, 2017 12

ANNUAL MEETING | #PCORI2017 Considerations for DUA • Definition of terms, parties, and relationship between parties • Description of repository’s hosting services and responsibilities • Description of requester’s responsibilities • Use of dataset for proposed research only • Commitment to not attempt to re-identify participants • Agreement to not re-distribute to data to unapproved 3 rd parties • Expectations for data citation, publication, submission of secondary analyses, and registration on ClinicalTrials.gov • Communication plans • Breach notification responsibilities and processes • Liability provisions • Duration of agreement and procedures for violation November 5, 2017 13

ANNUAL MEETING | #PCORI2017 Considerations for ICF • Aim to enable secondary use of collected data for open science • Explain “your” data, coded data, de-identified data, and anonymized data • Provisions to respect participant autonomy and privacy • Minimal but non-zero risk of re-identification • Minimal but non-zero risk of privacy breach • Information that will be obtained/ is required by PCORI • Opt-out provision for secondary use of collected data November 5, 2017 14

ANNUAL MEETING | #PCORI2017 Questions? Learn more about MRCT Center’s Data Sharing efforts at www.mrctcenter.org November 5, 2017 15

ANNUAL MEETING | #PCORI2017 Thank You! Rebecca Li, Ph.D. Senior Advisor, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Executive Director, Vivli November 1, 2017 November 5, 2017 16