News & Events

Category: Events

Future Directions: Real-World Data (RWD), Real-World Evidence (RWE) and Clinical Trials

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Join Vivli for a webinar discussing the differences between Real-World Data (RWD) and Real-World Evidence (RWE), and clinical trials. Different types of study designs can help answer different questions and this webinar will explore when these different approaches are deployed. The panelists will provide an overview of the RWD and RWE landscape, the regulatory perspectives and a case study on how RWE and RWD have been used in regulatory submissions. Join us as we explore where RWD and RWE fit in and how we can optimize its role in answering various questions. The webinar will be held on February 20 at 12 pm ET.

Our key topics include:
• The Real-World Evidence and Real-World Data landscape
• What kinds of questions RWE and RWD can help answer
• FDA perspective on the value created by using RWE
• Case Study on using RWD and RWE in a regulatory submission

Presenters:
Ida Sim, Vivli and UCSF
Marcia Levenstein, Vivli
Jack Mardekian, Rutgers University
Gregory Pappas, Food & Drug Administration

Credit for Data Sharing Webinar

Vivli, the Multi-Regional Clinical Trials Center (MRCT Center) and Association of American Medical Colleges (AAMC) present a discussion on methodologies for appropriating credit in data sharing. Dr. Barbara Bierer, MRCT Center Faculty Director, and Heather Pierce, Senior Director of Science Policy for AAMC share how purpose-driven data sharing both enhances scientific discovery and ensures data generators receive credit for their work. The webinar will be held Tuesday, November 12th at 11am EST.

Topics include:
• Methods for leveraging existing initiatives to track, use, and reuse impactful scientific data
• Benefits of purpose-driven data sharing to both public and scientific community
• Recommended policy and practice changes
• Role of journals, funders, and academic institutions

RECORDING

Presenters
Barbara E. Bierer, MD
Faculty Director, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
Co-Founder and Board Member, Vivli
Heather Pierce, JD, MPH
Senior Director – Science Policy, Regulatory Counsel, Scientific Affairs. Association of American Medical Colleges

Vivli Executive Director and Special Advisor presenting at NIH Grand Rounds

Vivli Executive Director Rebecca Li and Frank Rockhold, Vivli Special Advisor and Professor of Bioinformatics at Duke Clinical Research Institution, will present at the NIH Grand Rounds on September 27 from 1-2pm EST on Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers.

Li discusses datathon outcomes at RWE workshop

Vivli Executive Director Rebecca will present at the Drug Information Association’s (DIA) Future of Evidence Workshop session on Real World Evidence (RWE), Data Sharing and Data Transparency. Dr. Li’s presentation on “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon” will speak on October 25. The Switzerland based event runs October 24 – October 25, 2019 from 9:00am – 5:30pm. The workshop agenda includes three separate sessions on the important components in maximizing clinical utility, and the role of willingness to share data in this initiative.

Vivli Executive Director to Share Experience with Synthetic Data

Dr. Rebecca Li will discuss how Vivli used synthetic datasets as part of its data challenge with Microsoft on a webinar entitled An Introduction to Synthetic Clinical Trial Data. The webinar will be on October 4 at 11am-12pm EDT and is hosted by Replica Analytics. Sign up to the webinar today to find more about how synthetic data can be used to share clinical trial date while protecting participant privacy.

Register for Vivli’s Annual Meeting on September 18

“Working Together to Transform Data Sharing” 

The Vivli Annual Meeting event will be held at the DoubleTree by Hilton Hotel Bethesda.

The event is free but registration is mandatory, please register as soon as possible as space is limited.

Date: Wednesday, September 18, 2019. 

11:30 – 4:00 pm EST.

Location: DoubleTree Hilton – 8120 Wisconsin Avenue. Bethesda, MD 20814

If you are unable to attend in person, a livestream of the meeting is available. Sign up to attend the meeting virtually.

                                                         Agenda

Welcome remarks

Vivli Update for 2019 and Vision for 2020

Working lunch

Invited Speaker: Informed consent and secondary use of data for data sharing – David Peloquin, Ropes & Gray

Panel Discussion: Challenges of sharing small datasets and rare disease data

  • Patrick Cullinan, Takeda
  • Edith Eby, Pfizer
  • Robyn Himick, Amyloidosis Research Consortium
  • David Peloquin, Ropes & Gray
  • Susan Ward, cTAP

Lightning Rounds–Brief updates from Vivli stakeholders

  • Tianjing Li, Johns Hopkins University – Meta-analysis Utilizing IPD
  • Quan Chen, ImmPort, NIH – Data reuse partner
  • Gaurav Luthria and Qingbo Wang, Harvard University – Vivli Microsoft 2019 Datathon Grand Prize Winners
  • Heather Pierce and Anurupa Dev, Association of American Medical Colleges – Credit for data sharing
  • Pam Miller, New England Journal of Medicine – NEJM Experience with Data-Sharing Statements

Wrap-up and Next steps

Reception to follow.

Space is limited, reserve your seat today by registering.

Joint Vivli and CDISC webinar: Why Data Sharing and Data Standardization Matters

 

CDISC and Vivli are presenting an exclusive conversation with Vivli Executive Director Dr. Rebecca Li, UCSF professor and Vivli Co-Founder Dr. Ida Sim, and CDISC President and CEO David R. Bobbitt who will discuss how data sharing and data standardization go hand-in-hand in the quest to move scientific discovery forward. View a recording of the webinar.

WATCH RECORDING

Topics will include:

  • The importance of data sharing and shifting the data sharing landscape
  • How to increase data utility:  the benefits of data standardization
  • Working together

Presenters:

David Bobbitt, President & CEO, CDISC

Dr. Rebecca Li, Co-Founder, Vivli

Dr. Ida Sim, Co-Founder, Vivli; Professor of Medicine, University of California, San Francisco

By bringing together a global community of experts to develop and advance data standards of the highest quality, CDISC creates clarity in clinical research. CDISC enables the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health.

 

 

Rebecca Li to present at the OHRP Exploratory Workshop

Vivli Executive Director Rebecca to will speak at the Office of Human Research Protection  (OHRP) 2019 Exploratory Workshop Privacy & Health Research in a Data-Driven World on September 19. The Bethesda, Maryland, event runs from 8.15am-4.15pm EDT and will have a live webcast. The workshop agenda includes three separate sessions related to the theme of privacy and health research in a data-driven world and videos of each session will be available after the event. Dr. Li will speak on The Vivli Experience in Sharing Clinical Trial Data Globally.

Winners announced for Vivli Microsoft Data Challenge

More than 60 participants forming 11 teams, took part in the first Vivli Microsoft Data Challenge today at District Hall in Boston. Participants were from universities including Harvard, Northeastern, Brown, and Boston as well as nearby hospitals, pharmaceutical, biotech and software companies.

The data challenge focused on finding innovative solutions for how to safeguard participant privacy and minimize privacy loss while maintaining the scientific analytic value of the data for rare disease data sets that are more highly identifiable.

The day started off with a presentation by patient advocate Jane Perlmutter sharing with the attendees the importance of this challenge.

“I’m a long-term cancer survivor… patients don’t have the luxury of patience, she said. “When they enter a clinical trial, they’re hoping they would profit form it, hoping future generations won’t have to suffer from it as well.”  

The teams had one hour to plan and then four hours to come up with their solutions. They were then given five minutes to present their ideas to the judges.

“The Datathon has met our expectations, there’s a really diverse group of people that are rallying around solving a problem,” Paul Slater, co-founder of the Clinical Research Innovation Hub at Microsoft. “They’re discovering, there’s a bunch of innovative approaches to this, we don’t know if we’re getting an end solution but we may certainly get ourselves closer to it. This might be an opportunity to blend some of the best ideas together to make some meaningful products. The thing we’re going after is high impact.”

The winners are:

Global Grand Prize Winner: 

Team: DBMI

Participants: Gaurav Luthria and Qingbo Wang, Harvard University

Most Innovative Solution:

Team: DataHack

Participants: Cynthia Frommit (IND), Het Patel (Beth Israel), Vikas Gaikwad (Plural Point), Luther Evans (MGH Martinos Center), Annadoir Stavely (Otsuka USA) and Vikramen Karunanidhi (Ayu Devices)

Most Outstanding Graduate Submission:

Team: SAIL

Participants: Megan Fantes, Kinan Dak Albab, Wyatt Howe, Yi Zhang, Peter Flockhart, Lucy Qin from Boston University

Outstanding Remote Submission:

Team: Next Tech Lab

Participants: Sourva Sharan, Arjun Bahuguna from Next Tech Lab

Find out more about the Datathon and see the full list of Datathon submissions. 

 

Vivli Roundtable in Japan: One Year On: GDPR and Its Implications for Data Disclosure and Data Sharing  

Vivli will host roundtable discussions under the theme One Year On: GDPR and its Implications for Data Disclosure and Data Sharing. The meeting, scheduled for May 13, in Tokyo, Japan, will include discussion with experts in privacy and transparency of clinical trials.   

Speakers at the event include: