When

Friday May 17, 2013 from 7:30 AM to 5:00 PM EDT
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Where

Milstein East (2nd floor)
1585 Massachusetts Ave
Harvard Law School
Cambridge, MA 02138

Hyatt Regency Cambridge has a limited number of rooms available in the "MRCT/PFC Conference" block. Contact them directly for reservations: 617-492-1234 or by clicking here.

The Inn at Harvard has a special rate for attendees who mention the "MRCT PFC Conference" or group code 430063 when making reservations at 617-491-2222 or reservations@theinnatharvard.com

Additional nearby hotel accomodations

Please note: May is extremely busy for Boston and Cambridge hotels due to college graduation. Please book early.

Contact

MRCT Center at Harvard
Multi-Regional Clinical Trial Center

mrct@harvard.edu

Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

Objectives:

To convene key global stakeholders on a neutral platform to review evidence from recent case studies in clinical trial data disclosure
To discuss key areas of learning and potential solutions for clinical trial data sharing that may inform policy in this important area moving forward
To discuss implications of data sharing initiatives for pharmaceutical, medical device and biotechnology regulation in the U.S. and other countries

Schedule:

7:30 – 8:00
Participants arrive, Breakfast and Registration

8:00 - 8:15
Welcome Remarks, Barbara Bierer and Mark Barnes

8:15 - 8:35
Access to Patient-Level Data from Clinical Trials: What Data? For Whom? For What Reason? When?
Jeff Drazen, NEJM

8:35 - 8:55
Perspectives on Patient-level clinical data sharing from a patient advocate, bioethicist and industry physician
AJ Allen, Lilly

8:55 - 9:10
Q&A

Session I: Rationale for Increased Clinical Trial Data Sharing
Moderator: Michelle Mello, HSPH

9:10 – 9:25 am	Case Study: Model of data sharing among multiple stakeholders	Martha Brumfield, Critical Path Institute and Coalition Against Major Diseases
9:25 – 9:40 am	Case Study: A Review of Project Data Sphere	Leonardo Nicacio, Sanofi
9:40 – 9:55 am	What rationales exist for increased public sharing of clinical trial data? What types of data and how much data should be shared (e.g., pre-registration, post-registration, etc.)? Who stands to benefit from sharing more clinical trial data? For what parties will greater sharing of clinical trials data represent a significant burden? Must increased public sharing of clinical trial data be mandatory in order to achieve these benefits?	Pat Teden, Teden Consulting
9:55 – 10:35 am	Discussion Panel / Q & A	AJ Allen, Lilly John Orloff, Novartis Martha Brumfield, CPI Jim Ware, NEJM Pat Teden, Teden Consulting Peter Doshi, JHU Sally Okun, PatientsLikeMe Leonardo Nicacio, Sanofi
10:35 – 10:45 am	10 Minute Break

Session II: Safeguarding patient privacy, consent principles, and the integrity of data analyses
Moderator: Mark Barnes, MRCT/Ropes and Gray

10:45 – 10:55 am	Introduction of potential data sharing models	Michelle Mello, HSPH
10:55– 11:10am	Case Study: GSK Data Sharing Initiative as one model for increasing data transparency and a first step toward a broader solution	Jessica Scott, GSK
11:10 – 11:25 am	Case Study: How anonymous is genetic research data?	Yaniv Erlich, Whitehead Institute
11:25 – 11:40 am	What are the risks of clinical trial data sharing in regard to privacy protection, and how can they be balanced against the potential social benefits of data sharing? Would privacy concerns related to clinical trials data sharing constitute a barrier to participation to clinical trials? Does deidentification of data solve the problem of risks to patient privacy and confidentiality? Should research participant consent be a precondition for sharing of clinical trials data? What could be the consequences (e.g., liability) if/when privacy is compromised as the result of increased clinical trial data sharing?	Mark Barnes, Ropes & Gray / MRCT
11:40 – 12:20 am	Discussion Panel / Q & A	Judith Beach, Quintiles Yaniv Erlich, Whitehead Jessica Scott, GSK Mark Lim, Faster Cures Mark Barnes, Ropes&Gray / MRCT

12:20 – 12:40 pm	Lunch Served
12:40 – 1:00 pm	Lessons Learned from the implementation of FDAAA and the ClinicalTrials.gov Results Database	Deborah Zarin, NIH
1:00 – 1:10 pm	Q & A

Session III: Balancing companies’ intellectual property interests with public access to data
Moderator: Justin McCarthy, Pfizer

1:10 – 1:40 pm

Case Study: Legal issues posed by the EMA proposed initiative (including 10 min Q&A)

Richard Kingham, Covington

1:40 – 1:55 pm

What intellectual property rights, proprietary interests, and competitive concerns do pharmaceutical companies have that might be adversely affected by data sharing?
Would the impingement on these interests that could accompany data sharing likely affect public and private investments in R&D and, ultimately, innovation?
How should these concerns be balanced against the potential benefits of data sharing?
What strategies might effectively address companies’ legitimate concerns while maximizing the public benefit of data sharing?
Is imposing a “learned intermediary” between those who seek access to data and the data sources a possible approach to ease competitive concerns while still allowing reasonable access for independent researchers?

Jeff Francer, PhRMA

1:55 – 2:35 pm

Discussion Panel / Q & A

Susan Forda, Lilly

Ben Roin, HLS

Richard Kingham, Covington

Jeff Francer, PhRMA

Ira Shoulson, Georgetown

Aaron Kesselheim, HMS

Sandra Morris, J&J

2:35 – 2:50 pm

Afternoon Break

Session IV: Assuming patient-level data is shared in the public domain, what are the ramifications?
Moderator: Marc Wilenzick, MRCT

2:50 – 3:15 pm	EMA Update	Sabine Haubenreisser, EMA
3:15 – 3:40 pm	Anticipated Impact of BMJ’s Data Sharing Policy on the Publications and Scientific Process	Elizabeth Loder, BMJ
3:40 – 3:55 pm	What are the implications of public sharing of clinical trial data for regulatory processes? Do the potential benefits of data sharing for regulatory processes outweigh the risks (e.g., second-guessing regulatory agencies, premature or incorrect conclusions on risk/benefit profile of medicines)? Can a move toward increased public data sharing jeopardize ongoing efforts toward improved regulatory harmonization?	Jules Mitchel, Target Health Inc.
3:55 – 4:40 pm	Discussion Panel / Q & A	Bob O’Neill, FDA Sabine Haubenreisser, EMA Toshi Tominaga, PMDA Agnes Klein, Health Canada Deb Zarin, NIH Elizabeth Loder, BMJ Jules Mitchel, Target Health Inc. Evgeny Rogoff, Russia

4:40 – 5:00 pm

Wrap Up Discussion

Mark Barnes

Barbara Bierer

Rebecca Li

Holly Lynch

Limited Space Available!