News & Events

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 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

Vivli Program Manager Catherine D’Arcy Speaks at DIA Global Clinical Trial Disclosure & Transparency Conference

Vivli’s Program Manager, Catherine D’Arcy, spoke at DIA Global Clinical Trial Disclosure & Transparency Conference on October 18th in Amsterdam, presenting “Clinical Research Data Use: Insights From Vivli’s Experience Of Data Sharing.” More than 140 delegates attended from 16 countries.

The 2022 Global Clinical Trial Disclosure and Data Transparency Conference builds on prior successful conferences to leverage learnings from regulators and international experts in the field. This event will provide essential, timely information about global clinical trial disclosure, data transparency, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS) with the focus on transparency in relation to the protection of personal data and commercially confidential information. It brings leading study sponsors from industry and academia together with regulators and other players to exchange knowledge and share their experiences with the implementation of Clinical Trial Disclosure and Data Transparency from various viewpoints.

Vivli Senior Director Julie Wood Speaks at 19th Annual DIA Japan Annual Meeting 2022

Vivli’s Senior Director, Julie Wood, spoke at the 19th Annual DIA Japan Annual Meeting in Tokyo, Japan on October 11th for “Implementing Data Sharing in a Time of Pandemic.” The panel also included chair Azusa Tsukida, senior advisor to Vivli, and Dr. Oladayo Oyelola, Senior Director of Clinical Trial Information Disclosure at Daiichi Sankyo, Inc.

The theme of the 19th DIA Japan Annual Meeting is “New ‘Quest for the future’- Moving Creativity and Innovation Forward in ‘New Normal.’” Now that the world has experienced COVID-19, all will explore the future in a new normal environment. COVID-19 has brought about dramatic changes in our lives and activities. While face-to-face work declined dramatically, digital transformation accelerated quickly. This also promoted extremely rapid development of vaccines and therapeutic agents, as well as new clinical trial models including telemedicine. In addition, the importance of self-care associated with refraining from visiting medical institutions and the importance of addressing the issue of infodemics were reaffirmed.

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.

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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