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Leading Institutions Sign On to International Platform Which Aims to Accelerate Medical Research

Washington, DC—Today, the nonprofit organization Vivli launched a novel data-sharing and analytics platform to help researchers move faster toward new treatments and cures. This innovative platform makes it easy for researchers worldwide to discover, share and analyze data from clinical trials, regardless of who sponsored the research or where the research took place. Vivli launches today with 2,500 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 1.3 million trial participants.

The Vivli platform launches at a crucial time in the evolution of science. Increasingly, researchers are being required to make their data openly available. New guidelines issued recently by the International Committee of Medical Journal Editors demand that researchers share the data underlying their published results. Government and non-profit research funders are stipulating data-sharing as a condition of their grants. The culture within industry is also shifting to reward more open sharing of data. The Vivli platform boosts these emergent data-sharing efforts by bringing data from all clinical trials together in one place.

“To this day, much of the world’s clinical trial data is not shared, and even when it is shared, it is not integrated across the entire clinical research ecosystem,” said Vivli’s Executive Director Rebecca Li, PhD. “Vivli acts as a bridge, enabling researchers across the world to build upon each other’s work and speed up science.”

Vivli provides researchers with a secure, easy-to-use online platform to store and share clinical trial data across all diseases, nations and research entities. Vivli also allows researchers to freely combine and analyze data from multiple trials using state of the art tools. This means researchers can validate research findings—from confirming a treatment’s safety to identifying side effects—and avoid duplicative studies, thus reducing costs and shielding research participants from unnecessary risks. The data can also be combined to ask new research questions, such as how a disease evolves over time, and gain information to inform the design of future studies.

To ensure sustainability of the platform, Vivli is supported by a robust membership structure for industry, academic and non-profit research entities and their funders. Members commit to contribute data and, in the case of philanthropic organizations, cover the costs for grantees to share their data on Vivli. Current members and those with data contributing agreements include AbbVie, Aegerion Pharmaceuticals, Inc., Biogen, Inc., BioLINCC (National Heart, Lung, and Blood Institute), Critical Path Institute, Duke University, GlaxoSmithKline, plc, Harvard University; ImmPort (National Institutes of Health), Johns Hopkins University, Pfizer, Inc., Project Data Sphere, LLC, Takeda, The Leona M. and Harry B. Helmsley Charitable Trust, and the University of California, San Francisco.

Vivli evolved from a project at a policy center, The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, to enhance access to clinical trials data. For five years, a group of volunteers embarked on a mission to define, design and launch a global solution for sharing clinical trial data. “Sharing clinical trial data is critical in order to move science forward. We owe nothing less to the people who put themselves at risk by participating in these studies that benefit us all,” said Li.

The Vivli platform was built with grants from the Doris Duke Charitable Foundation, the Laura and John Arnold Foundation and The Leona M. and Harry B. Helmsley Charitable Trust. The platform is powered by Microsoft.

Statements from Vivli Supporters

Takeda

“Takeda is strongly committed to our core value of integrity and an important way to demonstrate this commitment is through maximizing the transparency of our clinical research. We see enormous potential in Vivli’s vision to create a more connected and interoperable data sharing landscape to positively impact the health of our patients. Takeda is proud to have participated in the development of the Vivli platform from its inception and we are excited to work towards full membership and collaborate with the Vivli community.” – Patrick Cullinan, Head of Clinical Transparency and Science Advocacy, Takeda

Helmsley Charitable Trust

“Every day, we are reminded of the urgent need to accelerate medical research. Too many people around the world are suffering from disease and need more effective treatments,” said Stephanie Cuskley, CEO of the Helmsley Charitable Trust, a founding member of Vivli. “Partners like Vivli offer a unique opportunity for research institutions to maximize their impact by sharing data and working together to propel new scientific discoveries forward.”

Project Data Sphere, LLC

“Aggregated patient-level cancer clinical trial datasets from across industry and academia, and managed within the Project Data Sphere cancer research platform, are already yielding new insights into understanding cancer and improving outcomes for cancer patients,” said Dave Handelsman, Vice President for Project Data Sphere, LLC.  “It’s exciting to collaborate with Vivli as their vision of data sharing enables research across a broad range of diseases”.

Duke University

“Duke University School of Medicine is pleased to partner with the Vivli Organization 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.”

The Bill & Melinda Gates Foundation

“We believe that the tools and discoveries capable of helping us tackle the world’s most pressing challenges – from age-old diseases like malaria to newer threats like drug-resistant superbugs – can only be realized through innovative thinking and global collaboration. Open access to data is critical for both of these things. This is why we are committed to increasing the impact of the research we fund so that it is open and accessible to all through platforms like the one developed by Vivli.” – Steven Kern, Ph.D., Deputy Director, Quantitative Sciences, The Bill & Melinda Gates Foundation

Pfizer, Inc.

“Pfizer participates in Vivli and other data-sharing platforms and collaborations because we believe that providing access to clinical data, when managed responsibly and in ways that respect patients’ privacy and preferences, may advance scientific knowledge and public health,” said Freda Lewis-Hall, M.D., Executive Vice President and Chief Medical Officer, Pfizer. “We hope that the Vivli platform will help the research community to solve unanswered questions for the benefit of patients.”

 GSK

“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.”

 Microsoft

“Strategic partnerships in healthcare and life sciences have become a major focus for Microsoft as an organization. We have a series of initiatives underway that will lead to improvements in the clinical trials process, and an increase of the value that can be extracted from clinical trials data. Vivli’s commitment to the ethical sharing of data for the greater public good and the advancement of open science makes them an ideal partner for Microsoft, and we look forward to deepening the partnership in coming years, as we look for innovative new ways to enhance the Vivli platform.” – Paul Slater, Co-Founder, Life Sciences Innovation, Microsoft

 Harvard University

“The mission of Vivli is fully aligned with that of Harvard University in promoting collaborative research and data sharing and transparency,” says Ara Tahmassian, Ph.D., Chief Research Compliance Officer, Harvard University.  Our faculty has a long history of data sharing.  Our commitment to Vivli reflects our support by providing one platform for our researchers to fulfill ICMJE and funder data sharing requirements.”

About Vivli

Vivli is a non-profit organization working to advance human health through the insights and discoveries gained by sharing and analyzing data. It is home to an independent global data-sharing and analytics platform which serves all elements of the international research community. The platform includes a data repository, in-depth search engine and cloud-based analytics, and harmonizes governance, policy and processes to make sharing data easier. Vivli acts as a neutral broker between data contributor and data user and the wider data sharing community. For more information, visit www.vivliorg.kinsta.cloud and follow us on Twitter @VivliCenter.

The live webcast of the Vivli platform launch at the National Academy of Sciences in Washington, D.C., on July 19 was attended by participants from all over the world. The platform is operational and accepting data requests.

If you are interested in knowing more about Vivli, please contact us at support@vivli.org.

 

CAMBRIDGE, MA-The Vivli platform is a new, groundbreaking digital platform where researchers can request and analyze clinical trial data sets in a secure research environment. Today Vivli announced a collaboration with Privacy Analytics, an industry leader sharing health data, data security and de-identification, to offer anonymization services to individuals and organizations who wish to share clinical data on the Vivli platform.  

“This collaboration will enable Vivli to meet the needs of a broad base of data contributors, by lowering one of the significant barriers to sharing sensitive health care data,” said Vivli Executive Director Rebecca Li. “Vivli allows sharing of clinical data sets regardless of the sponsor or therapeutic area, and by working with Privacy Analytics, we will open the Vivli platform to many data contributors previously unable to share their data as they were unable to anonymize their data.”  

For more than a decade Privacy Analytics has been an industry leader in the anonymization of healthcare data, for both research and data security purposes. Privacy Analytics “uses a risk-based approach to de-identification to maximize the value of real world data while following globally accepted standards and guidelines and complying with regulations in many jurisdictions worldwide.” This approach helps researchers to “effectively harness the value of health data for secondary use,” while simultaneously ensuring the safety of protected information.  

 “Privacy Analytics is eager to offer their services to Vivli Members,” said Khaled El Emam, CEO of Privacy Analytics. “Privacy Analytics’ anonymization services are a proven, responsible way to unlock the value of health data like the clinical data sets shared on the Vivli platform. By working with Vivli Members and other data contributors, we can help them to meet their data sharing requirements responsibly and cost effectively while also driving scientific breakthroughs.” 

 By collaborating with Privacy Analytics, Vivli is driving forward the use of emerging technologies to promote and enable clinical data sharing, with the goal of developing new discoveries to improve human health.   

About Vivli: 

Vivli is a non-profit organization that is establishing a global data-sharing and analytics platform to serve all elements of the international research community. We act as a neutral broker between data contributor and data user and the wider data sharing community. Vivli is establishing an independent data repository, in-depth search engine and a cloud-based analytics platform. We are working to provide the platform as well as harmonize the governance, policy and processes to make sharing data easier. The ultimate aim of Vivli is to advance human health from the insights and discoveries gained by sharing and analyzing clinical research .

 About Privacy Analytics:  

Privacy Analytics, an IQVIA company, allows healthcare organizations to quickly and easily apply a responsible risk-based de-identification methodology that protects individual privacy and ensures legal compliance. The company’s methodology and software have been deployed globally for different types of health data, including prescription, claim, EMR, hospital, registry, and clinical trials for both commercial and academic data sharing efforts. 

Vivli offers a new, groundbreaking digital platform where researchers can request and analyze clinical trial data sets in a secure research environment. Wellcome Trust has agreed to collaborate with Vivli and act as the secretariat for the data sharing platform’s Independent Review Panel (IRP). Vivli will launch on July 19^th, in an event at the National Academy of Sciences in Washington, D.C. Jennifer O’Callaghan, Clinical Data Sharing Manager at Wellcome Trust, will be speaking on a panel about this partnership at the event.

“Wellcome is pleased to be working with Vivli in their global effort to enable clinical trial data sharing,“ said O’Callaghan. “At Wellcome we share Vivli’s belief that clinical data sharing is a critical tool in modern medical and bioscience research. By enabling managed access to clinical trial data, Vivli and Wellcome will work together to help researchers make new discoveries that can positively impact human health.”

Wellcome is a longstanding, widely trusted global leader in health research and has years of experience in the role of IRP secretariat. As the IRP secretariat for the Vivli platform, Wellcome will bring valuable expertise, experience and vision to the newest horizon in global clinical data sharing efforts. They will play this role for data contributors who request this service to facilitate data requests made by researcher for their anonymized individual patient data.

“The Vivli team looks forward to working very closely with Wellcome Trust, in furtherance of our shared values and commitments regarding data sharing,” said Rebecca Li, Vivli’s Executive Director. “We feel that Wellcome Trust brings not only experience but a proven record of enabling critical research while also protecting the safety and privacy of research participants.”

With this partnership, Vivli offers those data contributors who wish to have an independent, neutral party oversee the review of requests access to an esteemed independent scientific panel who will review research proposals based on their scientific merit.

About Vivli:

Vivli is a non-profit organization that is establishing a global data-sharing and analytics platform to serve all elements of the international research community. We act as a neutral broker between data contributor and data user and the wider data sharing community. Vivli is establishing an independent data repository, in-depth search engine and a cloud-based analytics platform. We are working to provide the platform as well as harmonize the governance, policy and processes to make sharing data easier. The ultimate aim of Vivli is to advance human health from the insights and discoveries gained by sharing and analyzing clinical research data.

 About Wellcome Trust:

Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations, and spark debate.

 

Vivli Executive Director Rebecca Li gave a presentation about the Vivli platform at the Microsoft Life Sciences event, “Intelligent Medicines – Future Decoded,” in Cambridge, U.K. Dr. Li joined a distinguished roster of speakers on subjects at the intersection of health and technology, giving the audience an opportunity to learn about the Vivli platform and organization. The Vivli  platform, which will launch July 19th, harnesses the power and security of the Microsoft Azure cloud to enable clinical data sharing.  

Today we have added a Keyword Search to complement the PICO search to enable listing studies directly into Vivli for more basic searching. This change was made based upon feedback from our users. There are now 3 ways to search for studies on the platform—using the Keyword Search, PICO search, or quick search for looking up a single study. The Keyword Search will retrieve all studies that include the exact words you type into the search box whereas the PICO search allows you to refine your search using the vocabulary trees.

Vivli will continue to refine and update the beta website based upon user feedback so please do try out the beta version of the Vivli platform.

On March 13, Vivli’s Dr. Ida Sim participated in a panel of oral presentations around clinical and research data integration at the American Medical Informatics Association summit in San Francisco. Her presentation was entitled, “Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” Dr. Sim discussed how Vivli, as an impartial platform, will guide and create standards for individual participant-level data sharing, offering solutions to some of the problems that have long beset clinical researchers. Utilizing natural language processing technology, Vivli will identify information about participant Population, Intervention, Comparator and Outcome (PICO) elements and transform that information into fully searchable, computable fields.

A lively discussion about existing models of information sharing and future directions for the management of participant-level clinical trial data followed the presentation. If you attended the AMIA Informatics Summit and would like to learn more about Vivli, please get in touch with members of our team at contact@vivli.org to arrange a platform demo for your institution or company.

Clinical trials drive innovation and advance human health. With the launch of the Vivli platform, the global research community will gain a powerful new way to discover, share, and analyze clinical trial data. The platform launch event will be held at the National Academies in Washington, D.C. on July 19th. Attendance at the event is by invitation only as space is limited, so please get in touch with Vivli at contact@vivli.org if you would like to attend.

In addition to recognizing the diverse group of stakeholders and partners whose contributions have helped make the Vivli platform a reality, the launch will serve as a forum for discussion about the future of data sharing in the clinical trials research community. Details about the agenda will be made available nearer to event. We hope to see you there!