Executive Director Rebecca Li joined 2018 Innovative Approaches to Clinical Biomarker Validation conference as a presenter, demonstrating for the attendees the tools Vivli provides to assist in this critical research. The one-day conference, co-hosted by PORTAL, the Harvard Medical School Center for Bioethics, and the Harvard Program in Therapeutic Science, reviewed promising initiatives such as the Vivli platform, and the roles these initiatives can play in driving forward the use of biomarkers in clinical research. Dr. Li introduced Vivli as an innovative platform for sharing and analyzing IPD, including biomarker data.
Category: News
Vivli Data Analysis Challenge
Announcement and Call for Data Requests: Vivli Pioneers and Global Data Sharing Innovator Awards
Vivli is proud to launch the first of its data analysis challenges to support researchers to explore the studies that are available for searching and requesting on the Vivli platform. More than 3,100 studies are available for searching across numerous disease areas including hypertension, asthma, Crohn’s disease, dementia, and diabetes.
To encourage researchers to derive innovative analysis, drive forward scientific discoveries, and honor the contributions of trial participants, Vivli is launching two awards—the Vivli Pioneer and the Vivli Global Data Sharing Innovator Awards.
What:
The Vivli Pioneer Award will be conferred to the first approved 10 data requests that initiate analysis. The lead investigators of these data requests will receive $1,000 awards.
The Vivli Global Data Sharing Innovator Award will be conferred to the first 10 data requests that complete and publish their analysis in a peer-reviewed journal. The lead investigator of the data request team (or designated team member) will receive a travel award to enable presenting these results at a future global Vivli Data Sharing meeting.
Winners of the Vivli Pioneer Award are also eligible for the Vivli Global Data Sharing Innovator Award.
Who:
The award is open to all researchers and researcher teams other than those directly employed by for-profit companies.
For questions please contact support@vivli.org. Please use subject line: Vivli Analysis Data Challenge.
How to submit entries:
To be considered for either award, you need to submit a data request on the Vivli platform.
When:
Don’t delay, the first ten data requests that meet either award requirements will be selected. So the sooner you submit a data request the more likely you are to receive the Vivli Pioneer Award. You can then conduct your analysis and, once your results are published in a peer-reviewed journal, be awarded the Vivli Global Data Sharing Innovator Award.
Data Requests should include:
Data Challenge Analysis Requests will follow the Vivli Data Request process. More information, including how to fill out a data request, is available in the Resources section of our site.
To be eligible for the Vivli Pioneer Award and/or the Vivli Global Data Sharing Innovator Award, applicants must request and be approved for more than one study for analysis.
To stay up to date on the latest news about the Vivli Data Analysis Challenge and other news related to data-sharing, please sign up today.
“Increase Access to A Global Good” – interview with Vivli’s Dr. Rebecca Li
How Vivli and Privacy Analytics help data sharing for clinical trials research worldwide
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“Sharing clinical trial data is critical in order to inform clinical and regulatory decision making, and honor trial participants who put themselves at risk to advance science.”
– Barbara E. Bierer, M.D., Rebecca Li, Ph.D., Mark Barnes, J.D., LL.M., and Ida Sim, M.D., Ph.D., A GLOBAL, NEUTRAL PLATFORM FOR SHARING TRIAL DATA, The New England Journal of Medicine, article published May 11, 2016, at NEJM.org
Speaking to us from her office in Cambridge, Massachusetts, Dr. Rebecca Li, the Executive Director for Vivli, the non-profit organization that launched its clinical trials data sharing platform in July 2018, shared her perspectives. “As we’ve seen the evolution of clinical trials data sharing, there have been number of initiatives that have blossomed. But one of the gaps in the past, has been the ability to not only share the data, but also to integrate it for cross-platform data sharing. We believe that Vivli brings a unique added value in that regard. It is truly a global, neutral platform.”
Acting as a neutral broker between data contributor, data user and the wider data sharing community, Vivli’s stated objective is to harmonize governance, policy and processes to facilitate data sharing with an independent data repository, in-depth search engine and cloud-based, secure analytics.
Dr. Li provides a human dimension of the Vivli project: “The fact is, that patients who sign on for these clinical trials, want to share their data. When we talk to patients, they are surprised if their data is not being shared. They want to know that their contribution is playing a part in improving research, and advancing health. Therefore, the data needs to be anonymized to respect the patient’s contribution.”
“We occupy a unique position as an umbrella organization that brings together a variety of entities,” Dr. Li observes. Vivli’s members and partners are an esteemed list: The Bill and Melinda Gates Foundation, The Leona M. and Harry B. Helmsley Trust, Harvard University, Duke University, Johns Hopkins University, Pfizer, GSK, Takeda, Wellcome, and Biogen are among those who help make Vivli happen.
As the Vivli platform was designed and built to ensure the security of the anonymized clinical trial participant data that it hosts, enlisting a trusted partner to help data contributors anonymize their data, before sharing it with Vivli, was critical. Privacy Analytics, with its extensive experience in de-identifying highly sensitive personal health information datasets covering a wide bandwidth of sizes and types, was selected to apply its expertise. The pedigree of Privacy Analytics, its founder and Chief Executive Officer, Dr. Khaled El Emam, was a significant factor. “We needed a trusted partner. Dr. El Emam engaged with us during the blueprint stage, and his insights showed us how we could overcome barriers to implementation.”
“There are a number of challenges ahead,” Dr. Li adds. “These include contribution of data, which may exist in unstructured and/or structured form; and being able to use raw data when this is essential to the success of experiments.” Vivli’s impact extends to clinical trials that include patients in a variety of geographic and socioeconomic sectors. “With increased access to patient data, we as a profession, are moving together with our partners. And Vivli is enabling that increased access, for a global good.”
Visit Vivli on the web: https://vivli.org/
Thank you to Privacy Analytics for allowing Vivli to re-publish this piece.
How our team supports users on the Vivli Platform
Vivli is an innovative new clinical research data sharing platform with a robust search engine that has been created to meet the needs of researchers worldwide who use clinical research data. Using the Vivli platform, researchers can access anonymized data from more than 7,000 completed clinical trials.
My mission at Vivli is to lead the Operations team. Our team is proud to support our users on the platform in three important ways.
- Personalized support. We help users from request submission through the analysis process, and all the way to publication. By providing one-to-one interaction throughout, we’re available to answer specific questions regarding the Vivli platform, and to ensure that the experience is positive and efficient.
- The option to bring in your own statistical tools and data. Vivli allows you to incorporate your own tools and data sets into the platform. The ease and flexibility of Vivli’s platform allows you to spend less time on the process and more time focusing on your research.
- Streamlined process for Data Use Agreements. We harmonize legal agreements to streamline access to data. The first time your institution signs our Data Use Agreement is the only time they will have to sign it. After that point, only the lead researcher will have to sign the agreement. This should shorten the time between requesting and accessing data. Vivli makes sure you spend more time on science and less time on paperwork.
Sharing data is a critical component of high-quality research. We’ve created a support system for researchers who want to access or share data because we believe scientists should be doing science – not being bogged down by paperwork and processes. Vivli is working closely with our partners to make sure that our processes for sharing and accessing data are effective, responsive, and transparent. Visit our platform, or contact us directly at support@vivli.org, to learn more about how we can help with managing your clinical research data, or requesting data for use in your research.
Julie Wood, Director of Strategy and Operations
Li presents at the 2018 DIA Global Clinical Trials Transparency Conference
London, U.K.
Executive Director Dr. Rebecca Li spoke at the 2018 DIA Global Clinical Trials Transparency Conference. The three-day event brought together worldwide leaders in data sharing, including representatives from industry, researchers, governmental regulatory agencies and non-profits. Dr. Li introduced the Vivli platform as an innovative means of sharing individual patient data from completed clinical trials, to better support research while also enabling sponsors to meet their own data sharing and transparency mandates.
Duke University joins Vivli to drive forward data sharing.
Duke University joined Vivli as a founding Member organization, expressing their support for Vivli’s mission:
“Duke University School of Medicine is pleased to partner with Vivli to foster the principles of open science and data access from clinical studies,” said Adrian Hernandez, MD, Vice Dean for Clinical Research, Duke University School of Medicine. “At Duke, we are committed to developing research polices, platforms and methods to provide appropriate access to research information, with the ultimate goal of expediting the development of new treatments to improve the health of patients around the world.”
Dr. Frank Rockhold, Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, has long supported the mission of Vivli. Dr. Rockhold, pictured below at the Vivli launch event in July, has contributed valuable insights through the development of the Vivli platform.
Professor of Biostatistics and Bioinformatics Dr. Frank Rockhold, DCRI, speaking at the Vivli Platform launch
Duke shared their excitement about joining Vivli with a statement on their website, published to coincide with Vivli’s launch on July 19:
“The Duke University School of Medicine is pleased to announce our partnership with Vivli to foster the principles of open science and data access from clinical studies. This is the culmination of years of cooperative efforts between Vivli and Duke to develop the principles and infrastructure to support this effort. We took our experience from implementing our platforms (SOAR, Get Data at Duke, Duke Data Service) to create an even higher-level mission for the school.”
“At the Duke University School of Medicine, we are committed to developing research polices, platforms and methods to provide…
- Appropriate access to research information, so patient privacy is maintained, with the understanding that the nature of the study and sharing method will necessitate a range of privacy controls
- Proper oversight with minimum barriers to data access, to prevent against misuse of data, while promoting new discovery
- Maintaining utility of data, such that shared data can be used for new analyses
- An expectation that results of analyses from shared data will similarly be shared
- Acknowledgement of the work of original contributors
- We expect to apply these principles to apply to clinical trials sponsored or conducted by Duke and also set an expectation for our research partners. We feel these principles are in complete alignment with those of Vivli.
- We look forward to working with the Vivli leadership and their other Partners on the successful launch of the Vivli Platform. We are confident this effort will facilitate the delivery of clinical trial transparency.”
Read more here: Duke University Partners with Vivli to Engage in a New Era of Open Science
Why GSK is a member of Vivli
GSK, long an industry leader in data sharing and transparency, joined Vivli as a founding Member, illustrating their ongoing commitment to moving forward efforts to drive innovation. Director of Medical Advocacy and Policy Dr. Jessica Scott participated in the Vivli platform launch event and expressed GSK’s strong support for the Vivli mission.
“We began our journey sharing data with researchers in 2013 with a vision of a global data sharing platform, a one-stop shop where researchers could access data across industry, academic and government funded trials,” said Jessica Scott, Director Medical Advocacy and Policy at GlaxoSmithKline. “We are committed to transparency and accelerating the rate of scientific innovation to ultimately improve patient care. We are pleased to be contributing our trials to Vivli and we look forward to greater data sharing and use of these data across the clinical research enterprise.”
GSK also tweeted about the Vivli launch, reaching their more than 160,000 followers:
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See video of Dr. Scott’s comments at the Vivli launch event on July 19 below:
Wood presents at the 2018 Disclosure and Transparency for Clinical Data Summit
| Vivli Director of Strategy and Operations Julie Wood participated as a panelist at the 2018 Disclosure and Transparency for Clinical Data Summit, which took place in Philadelphia, PA, August 13-14. Wood demonstrated the Vivli Platform for the Summit attendees, who represented a diverse cross section of the data sharing community. Vivli gives those organizations invested in data sharing a new means of meeting their organizational goals. For more information, email contact@vivli.org. |  |
Media Coverage and Social Media Update
Media Roundup:
- Pink Sheet: Vivli Nonprofit Hopes To Be One-Stop Shop For Clinical Trial Data
- Science Magazine: Online portal of thousands of clinical trials could aid disease research
- Healthcare Informatics: Vivli Launches Clinical Research Data-Sharing Platform
Social Media:
Combined tweets to date including coverage from Science Magazine article:
- Reached 337k Twitter users
- With 584.7k impressions (estimated additional reach through retweets and shares)
- With 182 mentions from 76 users
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The Vivli Platform is live
We’re excited to announce the launch of our novel clinical trial data-sharing and analytics platform. Vivli will help speed up science and discovery and allow researchers to move faster toward new treatments.
Vivli is a nonprofit organization – a neutral site – housing the new platform that enables the integration of large scale clinical trial data sets provided by industry, academia, and nonprofits. The secure cloud-based platform features a robust search engine. This makes clinical trial data accessible for researchers worldwide, regardless of who sponsored the research or where it took place.
This launch includes more than 2500 studies from 15 organizations with data from more than 98 countries across numerous disease areas, including diabetes, Alzheimer’s and malaria, and representing the contributions of more than 1,300,000 trial participants.
We invite you to watch the video of our launch event, featuring:
• Rebecca Li, Vivli,
• Paul Slater, Microsoft,
• Ida Sim, UCSF and Vivli
The discussions also include testimonials from:
• Dr. Ara Tahmassian, Harvard University
• Jessica Scott, GlaxoSmithKline
• Gina Agiostratidou, the Leona M. and Harry B. Helmsley Charitable Trust
• Steven Kern, the Bill and Melinda Gates Foundation.
Vivli welcomed representatives from our fifteen Founding Member organizations: AbbVie, Aegerion Pharmaceuticals, Biogen, BioLINCC, Critical Path Institute, Duke University, GlaxoSmithKline, Harvard University, ImmPort, Johns Hopkins University, Pfizer, Project Data Sphere, Takeda, the Helmsley Charitable Trust, and UCSF.