News & Events

AstraZeneca will share patient-level clinical study data on Vivli

“We are delighted that AstraZeneca is joining as a Vivli member and making it possible for researchers to access the data from their clinical trials,” said Rebecca Li, Vivli Executive Director.Astra Zeneca logo

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

“AstraZeneca is very pleased to be joining Vivli,” said Julie Holtzople at AstraZeneca. “Through Vivli, we will strengthen our external data sharing capabilities with best-in-class research tools and the Wellcome Trust Independent Review Panel (IRP) in service of advancing human health.”

Vivli Article on Data Sharing Published in BMJ Open

Vivli is excited to announce it’s newest publication entitled Timely access to trial data
in the context of a pandemic: the time is now.

The article, published in BMJ Open, highlights how Vivli is addressing the needs of the COVID-19 challenge and demonstrates how the sharing of data collected from each trial participant enables combining of data to drive new scientific insights.

Vivli Executive Director to take part in panel at Northeastern University CLIC Annual Conference

Vivli Executive Director, Rebecca Li, will take part in a panel discussion next week as part of Northeastern University’s Center for Law, Innovation and Creativity Annual Conference.

The virtual conference, entitled This is What Democracy Looks Like – Exploring the Future of Governance Through Intellectual Property and Technology Regulation, will be held on Friday, October 16th from 9:00 am to 4:00 pm ET, and will feature discussions concerning transparency and innovation in health and medicine, election law, free speech and data privacy. Rebecca will participate in the first panel discussion on Privacy Incoherence in Medicines: The Confluence of Corporate Trade Secret, Government Non-Transparency, and AI Mediated Erosion of Patient Privacy.

Vivli team member to present at EMWA 2020 Symposium

Vivli’s Director of Strategy and Operations, Julie Wood, will be presenting at the 2020 European Medical Writers Association 2020 Virtual Symposium on 6 November 2020. The event’s theme is Research Integrity & The Medical Communicator: What We Do When Know One is Watching.

Wood’s talk is entitled Responsible Data-Sharing to Improve Research Integrity. View the full agenda

Synthetic Data Webinar: How to preserve privacy of participants when sharing clinical data

September 3 at 11AM ET

This 60-minute webinar will explore the emergence of synthetic data, a privacy preservation approach to protect individual patient data. Top experts will explain what synthetic data is, when and how to deploy this approach and share case studies about the successful utilization of using synthetic data and future applications of synthetic data.

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Topics include:
• Highlight issues faced by data contributors wishing to share data from rare diseases concerned about privacy issues
• Putting synthetic data in context with other privacy preservation approaches
• Case studies of successful use of synthetic data and how it applies to clinical research

Webinar attendees will have the opportunity to ask questions of the panelists.

Moderators:
Ida Sim and Marcia Levenstein, Vivli

Presenters:
Patrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra

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Vivli Executive Director to take part in panel at Duke-FDA event on rare diseases and data sharing

Vivli Executive Director, Rebecca Li, will take part in a panel discussion as part of Data Sharing to Accelerate Therapeutic Development for Rare Diseases hosted by Duke and the FDA. Her session will focus on platform analytics tools to support data sharing and drug development for rare diseases.

The Duke-Margolis Center for Health Policy, through a cooperative agreement with the U.S. Food & Drug Administration, is convening a two-day public meeting on August 18th and 19th, to discuss the importance of data sharing for accelerated therapeutic development in rare disease as well as considerations for sustaining and leveraging a robust data sharing infrastructure to support innovative rare disease trial design. The meeting will explore several topics including:

  • The importance of shared data to support innovation and quality in the drug development pipeline for rare diseases
  • Approaches and challenges to ensuring data quality, standardization, and interoperability in shared data resources
  • The role of regulatory agencies in strengthening rare disease data collection and shared data resources

Please see the event page for more details and to register for the event.

Mitsubishi Tanabe to share studies using the Vivli platform

Vivli extends a warm welcome to our newest member, Mitsubishi Tanabe Pharma.

“We are delighted to include Mitsubishi Tanabe studies on the Vivli platform,” said Rebecca Li, Vivli Executive Director. “By joining Vivli, Mitsubishi Tanabe will help drive scientific discovery through data sharing to advance human health.”

As a global research-driven pharmaceutical company, Mitsubishi Tanabe aims to contribute to the healthier lives of people around the world through creation of pharmaceuticals, focusing on Central nervous system, Immuno-inflammation, Diabetes & kidney, and Vaccines.

For more information about how Mitsubishi Tanabe shares its data on Vivli, please visit their member page. For additional information about Vivli membership, learn more here.

Taiho joins Vivli, a global data sharing platform

“We are delighted to welcome Taiho Pharma as a member of Vivli and to be able to partner with them to manage requests received for their individual patient-level data from completed clinical trials,” said Rebecca Li, Vivli Executive Director.

Taiho Pharma is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. As a company, they are determined to deliver new drugs that maximize health benefits to patients around the world.

For more information about how Taiho shares data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.

Vivli members commit to sharing data from COVID-19 trials

Members of Vivli, the Center for Clinical Research Data, announce today their commitment to share their COVID-19 trials through Vivli.

Members who have committed to sharing their data on the COVID-19 portal, a dedicated search function within Vivli for COVID-19 include Eli Lilly & Company, Regeneron, Roche, Takeda. Additionally, Cochrane, Covid Collaboration Platform, UCB, and the Wellcome Trust expressed their support of these efforts.

“Coronavirus is currently the most searched term on the Vivli platform and the new search experience is coupled with an accelerated process for data sharing. We believe that now, more than ever, sharing the individual participant data that underpins trial results is vital to driving forward both new science as well as scientific consensus,” said Rebecca Li, Vivli Executive Director.

“Vivli will continue to waive the fees for sharing for any interventional trial related to COVID-19 and to make the process as easy as possible. You don’t have to be a member to share your data using Vivli. We can and do share data from researchers from industry, academia, and non-profits. We have also partnered with vendors who can anonymize these datasets who have offered to anonymize the datasets waiving their normal fees. Vivli is doing all it can as part of the wider ecosystem of the health research community who are collaborating and coming together to do everything we can to find a treatment or vaccine for COVID-19.”

In March, Vivli announced the launch of a COVID-19 portal for sharing data trials. All member and user fees are waived. Vivli also partnered with anonymization vendors to waive the fees for anonymization of the data from COVID trials. In addition, the Wellcome Trust Independent Review Panel will provide an accelerated review process within three business days of receiving a request.

“We are committed to supporting timely and equitable access to data, and hope this streamlined service will produce important new discoveries from researchers who analyse the available data,” said Georgina Humphreys, from the Wellcome Trust IRP secretariat.

Vivli provides researchers with a secure, easy-to-use online platform to archive and share clinical trial data across all diseases and research entities. Vivli also allows researchers to combine and analyze data from multiple trials using state of the art tools.

Statements from Vivli Members and Supporters

“Roche is proud of its commitment to patients, and sharing COVID-19 study data through Vivli’s globally-respected platform allows researchers to leverage data to gain new insights at a time of critical need,” said Jeff Helterbrand, Global Biometrics Head at Roche. “We encourage the pharma industry, academia and research community to embrace the opportunity to responsibly share data for the benefit of all.”

“The evolving COVID-19 pandemic is profoundly impacting our lives, and places tremendous strain on healthcare systems and society at large. So, UCB is proud to support the work that the Vivli team is undertaking to drive collaboration and data sharing, as we believe this will enhance disease understanding, generate new insights, and may help develop new treatments to benefit patients worldwide,” said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB

“The COVID Collaboration Platform (CovidCP) is delighted to partner with Vivli to help academic researchers working on similar COVID-19 interventions collaborate and share data. Aggregating evidence across similar trials is crucial for understanding the best strategies to prevent and treat COVID-19, and Vivli will make it possible for us to help researchers design and run analyses to do just that.” – Elizabeth Ogburn from the CovidCP Executive Committee and Johns Hopkins University. https://covidcp.org/

Editor in Chief of the Cochrane Library, Karla Soares-Weiser said, “The pandemic represents a significant threat to global health, high quality evidence to inform decision making is needed urgently. Now, more than ever, fast, shared access to trial data is needed. Cochrane is pleased to support this initiative from Vivli as it promotes research integrity, transparency and acknowledges the value of timely and responsive production of evidence.”

Accelerating Science in the Age of COVID-19: Three Key Data Initiatives

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Join Vivli, COVID Collaboration Platform (CP) and TransCelerate BioPharma for a discussion of how these organizations are working to support academia, foundations and industry to collaborate and share data for COVID-19 trials.

The webinar will discuss the work that each organization is taking to support their stakeholders to more quickly collaborate, share and analyze COVID-19 data to accelerate science.

The webinar will be hosted on July 9 at 9 am Pacific/12 pm ET/6 pm CET.

Key topics include:

  • How each organization fits in the COVID-19 data ecosystem
  • Key features of each approach and how to continue to accelerate collaboration and data sharing related to COVID-19.
  • Ensuring collaboration and the various constituencies each initiative is primarily designed to support
  • How to overcome the challenges related to sharing individual patient-level data from COVID-19 trials.

Webinar attendees will have the opportunity to ask questions of the panelists.

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Presenters:
Rebecca Li, Vivli
Elizabeth L. Ogburn, Barbara Bierer, COVID Collaboration Platform
Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc