A reminder about our upcoming conference on Friday, May 17, co-sponsored by the Petrie-Flom Center and the Multi-Regional Clinical Trials Center at Harvard:
Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions
May 17, 2013, 8:00AM-5:00PM
Harvard Law School, Wasserstein Hall, Milstein West A (2nd Floor)
1585 Massachusetts Ave., Cambridge, MA
Our current agenda/objectives are below the fold, and will be updated with additional detail shortly. Please make sure to register as space is limited!
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 regulation in the U.S. and other countries
Agenda:
8am-8:15am – Breakfast and Registration
8:15am-8:30am – Welcome Remarks – Barbara Bierer
8:30am- 10:15am – SESSION I: Rationale for Increased Clinical Trial Data Sharing, moderated by Michelle Mello
- What is the need for increased public sharing of clinical trial data?
- What type and how much data (e.g., pre-registration, post-registration, etc.)?
- Who is going to benefit from sharing more clinical trials data and when?
- Who should be responsible for providing the resources required to share more data if/when needed?
- Should increased public sharing of clinical trials be voluntary or mandatory?
Case Study & Discussion
10:10am-10:25am – 15 Minute Coffee Break
10:25am-12:00pm SESSION II: Privacy/Confidentiality, moderated by Mark Barnes
- What are the risk of clinical trials data public sharing in regards to privacy protection?
- Can benefits to the patients from clinical trials data public sharing outweigh privacy concern and why?
- Can privacy concerns related to clinical trials data sharing constitute a barrier to participation to clinical trials?
- Is it truly possible to share patient-level data in a way that does not pose any risk to privacy and if so, what is the best approach to achieve that?
- What could be the consequences (e.g., liability) if/when privacy is compromised as the result of increased clinical trials data sharing?
Case Study & Discussion
12:00pm-12:30pm Lunch and Speaker
12:30 -2:10 PM SESSION III: Intellectual property, moderated by Barbara Bierer
- What are the risk of clinical trials data sharing on intellectual property protection?
- Can benefits to research from clinical trials data sharing outweigh the potential harm to R&D innovation that may result from a negative impact on IP protection, and if so how?
- Can IP protection concern provide a deterrent for public funding of clinical research and private investors in biopharmaceutical research?
- Are there ways to combine the potential benefits of clinical trials data sharing with the ability to protect IP and if so what is the most effective way?
Case Study & Discussion
2:15 – 2:30 Break
2:30pm-4:20pm SESSION IV: Regulatory Requirements, moderated by Marc Wilenzick
- What are the implication of public sharing of clinical trials for regulatory processes?
- Can potential benefits from public sharing of clinical trials on regulatory processes outweigh risks (e.g., second-guessing regulatory agencies, premature or incorrect conclusions on risk/benefit profile of medicines, etc,)?
- Can a move towards increased public sharing of clinical trials jeopardize ongoing efforts for improved regulatory harmonization?
Case Study & Discussion
4:20pm-5pm Wrap Up
Mark Barnes, Barbara Bierer, Rebecca Li
Please contact mrct@harvard.edu with any questions.
