News & Events

Vivli webinar: “Applying the SAFE Data Standard to Securely Share Clinical Trial Data”

Vivli hosted a webinar to discuss applications of the SAFE Data Standard as defined in “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data.”

The webinar was held on November 29th, 4pm CET/10am EST/7am PST.

VIEW THE RECORDING

This one-hour webinar features authors of the recently published paper “Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data,” presenting how data transformation is measured as part of the SAFE Data Standard and how to apply the SAFE Data Standard in different security contexts. This webinar is intended to help sponsors understand how to use the SAFE Data Standard to securely share rich clinical trial data to preserve data utility and for users of data to understand how accessing data in different contexts may change the utility of the data being provided.

Read the paper here!

Speakers include:
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance

Moderated by:
Marcia Levenstein, Senior Advisor, Vivli

 

View the Recording of Vivli’s 2022 Annual Meeting

“Enabling the Data Sharing Ecosystem”

Vivli’s 2022 Annual Meeting was held on Wednesday, November 2nd, 2022, 9:00am – 12:00pm EST / 2:00  – 5:00pm CET / 10:00pm – 1:00am JST. This meeting served as a chance to allow Vivli data contributors, key collaborators and funders to discuss data sharing and its importance for furthering scientific discoveries.

View the Recording

Agenda

Welcome remarks
Vivli Update for 2022, Rebecca Li, Executive Director, Vivli

Sharing COVID-19 Clinical Trial Data on Vivli
Reflecting on best practices and current experience

  • Julie Holtzople, Senior Director Clinical Transparency and Data Sharing, AstraZeneca
  • Steve Kern, Interim CEO, Global Health Labs
  • Ben Rotz, Associate Vice President – Global Medical Policy Strategy and Operations, Lilly
  • David Leventhal, Enterprise Clinical Trial Data Sharing Lead, Pfizer
  • Rebecca Sudlow, Global Lead Patient Level Data Sharing, Roche

Q&A

NIH Data Sharing Policy Changes in 2023

  • Dr. Susan Gregurick, Associate Director for Data Science and Director of the Office of Data Science Strategy (ODSS), NIH

Q&A

Data Challenges
Spotlighting data challenges Vivli is embarking on with key partners in 2022-2023

  • Deniz Dalton, Program Officer, The Leona M. and Harry B. Helmsley Charitable Trust, presenting “Moving Type 1 Diabetes and Exercise Data to Solutions”
  • Tetsuyuki Maruyama, Executive Director, Alzheimer’s Disease Data Initiative (ADDI), presenting “ADDI/Vivli Data Challenge in Alzheimer’s Disease”

Next Steps and Discussion

Vivli partners with The Helmsley Charitable Trust to share T1D exercise data

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program announced the launch of their initiative to support novel, real-world solutions to help people with type 1 diabetes exercise safely and to improve their quality of life. Helmsley collaborated with the Jaeb Center for Health Research (JCHR) and a group of investigators to conduct two large observational exercise studies in people with type 1 diabetes (T1D) and is now making the data from the studies publicly available with Vivli. To amplify its impact, Helmsley is also opening a request for proposals (RFP) for researchers, clinicians, and data scientists to analyze the data and test novel solutions in people with T1D.

“Vivli is delighted to facilitate access to these important data sets through a Helmsley grant, and to play a part in the advancement of T1D scientific research,” said Rebecca Li, Vivli Executive Director.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Read Helmsley’s full press release here.

Researchers who have approved requests for the RFP

The table provides the information of researchers who have accessed the Jaeb Center for Health Research T1D Exercise Dataset via Vivli and indicated that they will be applying for the Helmsley request for proposal.

ResearcherInstitution
Lane DesboroughNudge BG, Inc.
Gijsbert StoetUniversity of Essex
Emily FoxStanford University
Dale MorrisonUniversity of Melbourne
Hector Romero UgaldeDiabeloop SA
Daria IgudesmanAdventHealth Translational Research Institute
Marzia CesconUniversity of Houston
Monia RekikUniversité Laval
Boomer OlsenUniversity of Utah
Janet Snell-BergeonUniversity of Colorado
Ali CinarIllinois Institute of Technology
Jenna WiensUniversity of Michigan
Arsalan ShahidCeADAR: Ireland's Centre for Applied AI at University College Dublin
Daniel WestNewcastle University
Ahmad HaidarMcGill University
Pratik AgrawalMedtronic Diabetes

Vivli partners with The Helmsley Charitable Trust to share T1D exercise data

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program announced the launch of their initiative to support novel, real-world solutions to help people with type 1 diabetes exercise safely and to improve their quality of life. Helmsley collaborated with the Jaeb Center for Health Research (JCHR) and a group of investigators to conduct two large observational exercise studies in people with type 1 diabetes (T1D) and is now making the data from the studies publicly available with Vivli. To amplify its impact, Helmsley is also opening a request for proposals (RFP) for researchers, clinicians, and data scientists to analyze the data and test novel solutions in people with T1D.

“Vivli is delighted to facilitate access to these important data sets through a Helmsley grant, and to play a part in the advancement of T1D scientific research,” said Rebecca Li, Vivli Executive Director.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Read Helmsley’s full press release here.

Vivli team authors new publication in Health Data Science

The Vivli team, led by Executive Director Rebecca Li, recently authored a paper entitled “Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse.” This paper aims to raise awareness of the ecosystem of health-related data sharing platforms available for researchers to access high-quality data, and thus advance science by accelerating their scientific goals.

Vivli’s ultimate goal is to continue to grow our repositories (Vivli and the AMR Registry) to include more data available for reuse, to broaden the availability of data for researchers and raise awareness of these platforms amongst the scientific community to utilize these freely available valuable resources for their research.

Vivli webinar with CRDSA: “Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologies.”

Vivli hosted CRDSA to explore findings of their newly published whitepaper, “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies.”

The webinar was held on October 6th, 11am EDT/8am PDT/5pm CEST.

VIEW THE RECORDING

This one-hour webinar featured the authors from the CRDSA’s new white paper “A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies” in a lively a moderated discussion with CRDSA’s CEO, Aaron Mann. This webinar explored findings from the white paper that examines sponsor’s data sharing policies and protection methodologies as well as reflections on actionable steps for sponsors and secondary analysis researchers alike.

  • For Researchers: Understand the policy and privacy elements that can impact research utility
  • For Data Contributors: Identify meaningful benchmarks to help guide policy development

Read the whitepaper here!

Speakers include:
Luk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB

Moderated by:
Aaron Mann, CRDSA CEO

 

Bayer Signs Up as a Member of Vivli

“We are thrilled to welcome Bayer as a member of Vivli,” said Rebecca Li, Vivli Executive Director. “We look forward to supporting researchers to request and analyze Bayer’s data securely.”

As a global leader in healthcare and nutrition, Bayer offers innovative products that support efforts to overcome challenges presented by a growing and aging global population by helping to prevent, alleviate and treat diseases.

“We are very excited to join Vivli and the large global community of leading clinical trial sponsors engaged in data sharing. Vivli offers a great opportunity for Bayer to further strengthen our commitments to transparency and data sharing for our clinical trials”, says Sigrid Achenbach, Head of Clinical Trial Transparency at Bayer.

For more information about the conditions for accessing Bayer anonymized data from completed clinical trials, please visit their member page. For additional information about Membership in Vivli, learn more here.

President Selects former Vivli External Advisory Committee member as National Cancer Institute Director

Vivli enthusiastically congratulates Dr. Monica Bertagnolli on her recent appointment as Director of the National Cancer Institute (NCI).

Dr. Bertagnolli has served as a long-time member on the Vivli External Advisory Committee.

“We are glad to see Dr. Monica Bertagnolli take on such an impactful role and we wish her all the best,” said Rebecca Li, Executive Director.

Biden Selects Harvard Professor as National Cancer Institute Director – The Harvard Crimson

Ipsen joins Vivli to Share its Data

“We are pleased that Ipsen has joined Vivli as a member,” said Rebecca Li, Vivli Executive Director. “By joining Vivli as a member, Ipsen is meeting the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.”

Ipsen’s vision is to be a leading global mid-size biopharmaceutical company, with a focus on transformative medicines in three key therapeutic areas: oncology, rare disease and neuroscience.

“We at Ipsen are delighted to be joining Vivli to share Ipsen anonymized clinical trial data”, said Heather White, Senior Vice President, Clinical Development Operations R&D at Ipsen. “Responsible data sharing, in accordance with applicable laws and regulations, is essential to accelerate innovation and drive positive impact for patients whilst safeguarding patient data.”

For more information about the conditions for accessing Ipsen’s data, please visit their member page. For additional information about Membership in Vivli, learn more here.

Vivli Senior Director Julie Wood to Speak at Future-Proof Your Clinical Data Disclosure, Transparency and Plain Language Summaries Event

Clinical Trials- Informa Connect is hosting a hybrid event, “Future-Proof Your Clinical Data Disclosure, Transparency and Plain Language Summaries,” in June 2022. They will be featuring Vivli’s Senior Director, Julie Wood, in their series on Data Sharing Challenges in the presentation, “CASE STUDY: Sharing of Covid-19 Trials on Data Sharing Platforms.”

  • Julie WoodDirector of Strategy and Operations, Vivli
  • Julie G. HoltzopleHead of Clinical Transparency and Data Sharing, AstraZeneca

The presentation will focus on the challenges, opportunities and key learnings from the use of data sharing platforms; and progress and developments for multi-sponsor platform for sponsors and researchers. She will also answer the question: As data sharing becomes the norm, what should a sponsor consider when deciding on how to securely share clinical data?

Register for the session, which takes place on June 14, 2022 from 3:30pm – 4:00pm EDT.