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Vivli to launch a portal for sharing data from COVID-19 trials

Access to data from completed coronavirus trials would be made available to all qualified researchers

Cambridge, MA–In a visible sign of data sharing leadership, Vivli, the Center for Clinical Research Data, has committed to serving the open science community through the launch of a COVID-19 portal for sharing of completed interventional treatment trial data. All member and user fees would be waived for sharing and access.

“Today, we are announcing this initiative as it is so important for the entire data sharing community to come together and do everything we can to share the data from these completed clinical trials,” said Rebecca Li, Vivli Executive Director. “Sharing data transparently and openly is the best way to honor the decisions made by participants in these trials and bring us closer to safe and effective treatments and vaccines.”

Vivli co-founder, UCSF professor and lead author of a Science article published today that advocates for more open data sharing by the NIH echoed these concerns.

“Vivli has been at the forefront of data sharing and I am delighted to see us do all that we can to advance the knowledge around the COVID-19 pandemic,” Sim said. “Vivli was created to make data sharing practical and easy to do. COVID-19 trials should be made open to all researchers so that no stone is left unturned in reviewing and analyzing the data.”

The new article, published in the Policy Forum section of Science by Vivli and key data transparency leaders advocates for additional changes and enhancements to strengthen the current draft NIH Data Sharing Policy. In the piece the authors recommend, “Specific, practical, and implementable NIH policies can help transform academic culture and practice toward routine data sharing.”

Authors of the article include Ida Sim, Michael Stebbins, Barbara E. Bierer, Atul J. Butte, Jeffrey Drazen, Victor Dzau, Adrian F. Hernandez, Harlan M. Krumholz, Bernard Lo, Bernard Munos, Eric Perakslis, Frank Rockhold, Joseph S. Ross, Sharon F. Terry, Keith R. Yamamoto, Deborah A. Zarin and Rebecca Li.

About Vivli

Vivli is a non-profit organization working to advance human health through the insights and discoveries gained by sharing and analyzing data. It is home to an independent global data-sharing and analytics platform which serves all elements of the international research community. The platform includes a data repository, in-depth search engine and cloud-based analytics, and harmonizes governance, policy and processes to make sharing data easier. Vivli acts as a neutral broker between data contributor and data user and the wider data sharing community. For more information, visit www.vivli.org and follow us on Twitter @VivliCenter.

Vivli’s response to Coronavirus COVID-19

We hope you are well in this moment of uncertainty due to COVID-19.

We are reaching out at this time to let you know the steps we are taking to safeguard the well-being of both our employees and users.

• Staying in contact via remote technology whenever possible. We are a dispersed team primarily
concentrated in the Boston-area and are well-versed in the use of these remote technologies.
• Minimizing all non-essential business travel.
• Working closely with our vendors to minimize the potential impact of any user disruptions on the
Vivli platform.
• We will keep you updated as needed as the situation evolves.

In the meantime, please continue to direct all inquiries to support@vivli.org

Dr. Ida Sim Presents at NIH Workshop on Role of Generalist Repositories to Enhance Data Discoverability and Reuse

Dr. Ida Sim, Vivli co-founder and UCSF professor, shared with attendees the case study of about Vivli as a data sharing platform focused on the sharing of clinical research at the NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, which was held in Bethesda, Md. The event was hosted by the Office of Data Science Strategy and the National Library of Medicine. To establish a more comprehensive FAIR biomedical data ecosystem, NIH is investigating the roles of generalist and institutional data repositories in the biomedical data repository landscape.

View Dr. Sim’s slides from the event, where she spoke about Vivli’s contribution to data discoverability and reuse.

 

Vivli 2019 Progress Report published

We are delighted to share with you Vivli’s 2019 Progress Report, which highlights our milestones to date and plans for the year ahead.

We look forward to continuing to grow together in 2020 and beyond, as leaders in data sharing and transparency, working together towards our end goal of advancing human health.

Vivli team to speak at National Academies Meeting on sharing clinical trial data

Challenges and a Way Forward in Sharing Clinical Trial Data: A Workshop on November 18-19, 2019

Vivli Executive Director, Rebecca Li, will speak about the Vivli platform on the first day and Vivli founder and technical lead, Ida Sim, will moderate a session on the second day about Overcoming Usability and Sustainability Challenges.

The workshop will explore challenges, and opportunities in clinical trial data sharing efforts since the release of the 2015 Institute of Medicine report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.

WORKSHOP SPEAKERS WILL:

  • Consider the value and the potential risks/costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients;
  • Review the current landscape of clinical trial data sharing and reuse across public and private sectors (e.g., policies, platforms, collaborations, data sharing culture, published research output);
  • Examine use cases and trends from across public and private sectors when it comes to success, failure, lessons learned, and value;
  • Consider the perspectives and expectations of primary and secondary researchers, clinical trial participants, patient organizations, research sponsors (pharmaceutical companies and nonprofit organizations), journals, institutions, and federal agencies; and
  • Discuss next step opportunities for stakeholders to better harmonize incentives, policy, data standards, and governance to encourage the sharing and reuse of clinical trial data.

This workshop is co-sponsored by the Wellcome Trust and convened under the auspices of the National Academies Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health.

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

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.

Johnson & Johnson joins Vivli as a member

“We are delighted to have Johnson & Johnson join Vivli as a member,” said Rebecca Li, Vivli Executive Director. “This partnership will drive science forward by enabling the combination of J&J data with sources available from Vivli’s other member organizations.”

Read more about the partnership in this post by Joanne Waldstreicher, Chief Medical Officer at Johnson & Johnson.

 

Watch the recording of Vivli’s Annual Meeting

The Vivli Annual Meeting event on Wednesday, September 18, 2019 was recorded.

For those who are unable to attend the meeting in person, you can view the proceedings.

Annual Meeting 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

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.