News & Events

Category: News

T1D exercise data RFP from Helmsley Charitable Trust due the end of this month

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program has launched an initiative to support innovative and practicable solutions to help people with type 1 diabetes (T1D) exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley supported a research collaboration centered on two large observational exercise studies in people with T1D: one in adults (T1-DEXI) and one in children (T1-DEXIP). More than 500 people took part in the adult study, and another 250 in the pediatric study. Both studies were recruited and conducted fully remotely by design, enabling full monitoring and data collection which was unimpeded by COVID-19 pandemic restrictions.

The data from these studies include information about types of physical activity, heart rate, insulin use, CGM, diet, and genetics. The research collaboration collected and organized the observational data to maximize interoperability, and Helmsley has partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available. Sharing study data publicly will enable a range of researchers to access and explore the data from a variety of perspectives and research specialties.

In addition to facilitating public access through the Vivli platform, Helmsley has also opened a request for proposals (RFP) to support researchers, clinicians, and data scientists interested in analyzing the data and testing novel solutions in people with T1D. The RFP aims to fund projects that will improve the understanding of how exercise impacts T1D and that will provide people with T1D and their healthcare providers practical management solutions and clinical guidelines. The overarching purpose of this initiative is to move real-world data towards real-world solutions.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Researchers interested in exploring the T1D dataset on Vivli in order to prepare concept notes for submission can search data publicly available through Vivli’s search portal, and submit a data request using the standard process. Complete information about the RFP, including key dates and submission criteria, is available on The Helmsley Charitable Trust site.

Deniz Dalton, Program Officer in T1D at Helmsley, said, “People with T1D face many burdensome challenges in their daily lives, including complex decisions around exercise, diet, monitoring glucose levels, and administering insulin. We are excited to make this data publicly available and to launch this RFP, to advance the understanding of how exercise affects glucose management, and ultimately to help create real-world solutions to challenges faced by people with T1D around exercise.”

For more information, please watch Dalton’s presentation on this initiative at the Vivli 2022 Annual Meeting, or contact Vivli User Support directly at support@vivli.org with any questions

Vivli webinar: Recent Developments in Data Privacy Laws and their Impact on Data Sharing

Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.

The webinar was held on Monday, April 24th at 3pm CEST / 2pm BST / 9am EDT.

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The People’s Republic of China (PRC) enacted a comprehensive data privacy law called the Personal Information Protection Law (PIPL) in November 2021. This law adds to an already complex data privacy framework in the PRC, which also includes the Regulation of Human Genetic Resources, the Biosecurity Law of the PRC and the Data Security Law of the PRC. This webinar will focus on key implications of the PIPL and these other PRC laws for the sharing of clinical trials data generated in the PRC for further research purposes. The speakers will also make comparisons between PIPL and the European Union’s General Data Protection Regulation (“GDPR”), another global privacy law that has had a significant impact on the sharing of clinical trial data.

Learning objectives for this session include:
• Understand the basics of PIPL
• Understand how PIPL affects sharing of clinical trials data across international borders
• Understand key differences between PIPL and GDPR

Speakers:
• Rebecca Li, Vivli
• David Peloquin, Ropes & Gray
• Katherine Wang, Ropes & Gray

This webinar is intended for organizations and individuals that share data and will be particularly useful for those who focus on data privacy.

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Vivli Executive Director Dr. Rebecca Li Speaking at NIA-DUKE-Alzheimer’s Association Workshop

Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.

The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.

Submitting Your NIH Data Management and Sharing Plan using Vivli

The NIH Data Management and Sharing (DMS) policy went into effect in January 2023 to promote the sharing of scientific data.

Please watch Vivli’s recent webinar and find out more about how Vivli can help you navigate the NIH Data Management and Sharing policy. Hear from academic staff on their experiences in supporting researchers with their Data Management and Sharing Plans (DMSP).

During this webinar, we:

  • Provide an overview of Vivli, including what types of data should be shared in Vivli
  • Discuss the benefits of using Vivli to meet the data sharing requirements of your NIH grant
  • Review the steps to completing the NIH DMSP and budget justification
  • Hear views from academic staff on their experiences supporting researchers to complete the new NIH DMSP

Speakers include:

  • Anne Seymour, Johns Hopkins University
  • Amy Nurnberger, Massachusetts Institute of Technology
  • John Borghi, Stanford University
  • Rebecca Li and Julie Wood, Vivli

Participants had the opportunity to ask questions. This webinar is most useful for current or prospective NIH grantees or those who support them.

View Recording

Vivli version 3.0 of the platform has been released

Version 3.0 of the Vivli platform has been released and is available to users. The key change with the new version of the platform is that it is now possible for researchers to submit their completed clinical study through platform. This change is aimed academic researchers so they can meet funder requirements.

“To make it easier for researchers who want to share the results of their completed clinical trials to meet funder and publication requirements, it is now possible for researchers to answer a few questions and submit their studies for sharing,” said Julie Wood, Vivli Senior Director. “We think this will make it much easier for academic researchers to share their data.”

Other minor useability changes have been made and the tools and software in the research environment has been updated.

Galapagos joins Vivli as its newest member

“We are delighted to welcome Galapagos 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.

The Galapagos mission is to develop transformational medicines in areas of high unmet need by combining internal with external science with the goal to add years of life and improve quality of life of patients across the globe.

At Galapagos, we believe that transparency of clinical study data promotes strong scientific research and advances science and medicine. Galapagos commits to ensure full compliance with all applicable laws and regulatory guidance and provides specific attention to the protection of personal data at study participant level.

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

Vivli 2022 Progress Report Published

We are delighted to share with you Vivli’s 2022 Progress Report, which highlights our milestones to date and plans for the year ahead.

We look forward to continuing to grow together in 2023 and beyond, as leaders in data sharing and transparency, working together towards our end goal of advancing human health.

 

 

Vivli Executive Director Rebecca Li to Speak at AI-Enhanced Clinical Trials Summit in Boston

Vivli’s Executive Director, Rebecca Li, will speak at the AI-Enhanced Clinical Trials Summit in Boston on December 8th for “Unlocking Sensitive Healthcare Data To Optimize Clinical Trials And Encouraging Clinical Research Data Sharing.” Highlights will include the ethical and practical challenges of accessing patient data and how best to overcome shared challenges.

With drug development costs rapidly increasing, decision makers are right to be turning to novel AI/ML technologies to optimize clinical trial processes and de-risk drug development pipelines. Looking from both a patient-engagement and internal-process perspective, the AI-Enhanced Clinical Trials Summit takes a closer look at how available and scalable AI technologies are accelerating and improving clinical trials.

Learn more here.

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.

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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