Vivli’s co-founder Ida Sim to speak at a webinar hosted by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) for researchers to learn how to share, discover, and cite COVID-19 data and code in generalist repositories. Dr. Sim will speak to Vivli’s involvement in supporting discoverability and reusability of COVID-19 data on Friday, April 24th at 2:10 pm ET.
View Dr. Sim’s slides from the presentation.
Privacy Analytics has partnered with Vivli in a consortium to accelerate the COVID-19 response through sharing of participant data from COVID-19 clinical trials via Vivli’s COVID-19 portal.
“Privacy Analytics is wholly committed to the global effort to respond to COVID-19. We have the collective will, the personal urgency and the technical ability to make a meaningful difference in the fight against COVID-19,” said Sarah Lyons, General Manager, Privacy Analytics. “We are committed to working with Vivli and doing our part to accelerate treatment for COVID-19. I am encouraged and inspired by the dedication and the devotion of our team, and by the speed with which the global healthcare community has rallied in this time of crisis.”
As jointly announced at our April 2 webinar, Privacy Analytics will waive fees to anonymize data from qualifying COVID-19 vaccine and pivotal drug trials. Vivli has also waived all fees to share, archive and access COVID-19 trials.
“We are appreciative of our long-term partnership with Privacy Analytics,” said Rebecca Li, Vivli Executive Director. “Making anonymization as easy as possible for those sharing COVID-19 clinical trials is a vital step forward so that these data can be shared more widely.”
d-wise offers anonymization services to studies available on Vivli COVID-19 portal
Breaking News— d-wise and Vivli are partnering to accelerate COVID-19 data sharing. d-wise will waive fees to anonymize COVID-19 studies made available through the Vivli platform. Vivli launched its COVID-19 portal last week and announced it will waive fees to share, archive and access all of its clinical trials related to COVID-19.
“We are deeply grateful by the offers of support we have received to lower the barriers to those conducting COVID-19 clinical trials,” said Rebecca Li, Vivli Executive Director. “Making anonymization as easy as possible for those sharing COVID-19 clinical trials is a vital step forward so that these data can be shared more widely. We are pleased to be able to provide an end-to-end offering for COVID-19 data sharing.”
“Sharing data powers medical innovation. The time is now – we encourage those conducting clinical research to contribute and share data as part of the global response,” said Stephen Baker, Director of Strategic Accounts at d-wise. “d-wise is proud to play its part to accelerate the sharing ecosystem in the fight against COVID-19.”
Vivli is working with d-wise, along with other stakeholders, to share the data from COVID-19 trials.
About d-wise:
d-wise is committed to helping pharmaceutical, biotech, contract research organizations, and medical device companies navigate technology change in pursuit of human health and wellbeing. With deep domain experience in biometrics, software engineering, statistical programming, standards, and change management, d-wise products and services power innovation to accelerate clinical trial data analysis and data sharing.
For questions and inquiries, please contact d-wise at info@d-wise.com or visit www.d-wise.com/transparency.
If you have other ways you can contribute to the COVID-19 effort, please let us know.
The current pandemic represents an opportunity for scientists and partners to work together towards a global response. On March 20, 2020 for sharing of clinical trials. All fees will be waived for sharing and access. Find out more about the process.
Vivli announced the launch of the COVID-19 portal as part of our desire to do our part in response to the global pandemic. We believe this will help us work toward our ultimate vision to advance human health through clinical research data sharing and to respect and honor the contributions of clinical research participants. As we all confront this challenging situation, the time for sharing data and ensuring that we are all doing what we can as a scientific community to advance human health has never been more pressing.
If you or your organization has research data from a COVID-19 related trial to share or wish to connect with Vivli on how your organization can help, please get in touch with us in filling out the form below and we will respond shortly.
Regeneron joins Vivli, reinforcing their commitment to data transparency
“We are pleased to welcome Regeneron as a member of Vivli,” said Rebecca Li, Vivli Executive Director. “Regeneron is acting on its commitment to drive forward scientific discovery and advance human health by sharing individual patient-level clinical data from certain completed trials with approved researchers.”
Regeneron is a leading biotechnology company that delivers life-transforming medicines for people with serious diseases.
For more information about how Regeneron shares clinical trial data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.
Vivli is leading global non-profit data sharing platform that serves the international community and supports biotechnology companies like Regeneron to further their commitment in data transparency.
Access to data from completed coronavirus trials would be made available to all qualified researchers
Cambridge, MA–In a visible sign of data sharing leadership, Vivli, the Center for Clinical Research Data, has committed to serving the open science community through the launch of a COVID-19 portal for sharing of completed interventional treatment trial data. All member and user fees would be waived for sharing and access.
“Today, we are announcing this initiative as it is so important for the entire data sharing community to come together and do everything we can to share the data from these completed clinical trials,” said Rebecca Li, Vivli Executive Director. “Sharing data transparently and openly is the best way to honor the decisions made by participants in these trials and bring us closer to safe and effective treatments and vaccines.”
Vivli co-founder, UCSF professor and lead author of a Science article published today that advocates for more open data sharing by the NIH echoed these concerns.
“Vivli has been at the forefront of data sharing and I am delighted to see us do all that we can to advance the knowledge around the COVID-19 pandemic,” Sim said. “Vivli was created to make data sharing practical and easy to do. COVID-19 trials should be made open to all researchers so that no stone is left unturned in reviewing and analyzing the data.”
The new article, published in the Policy Forum section of Science by Vivli and key data transparency leaders advocates for additional changes and enhancements to strengthen the current draft NIH Data Sharing Policy. In the piece the authors recommend, “Specific, practical, and implementable NIH policies can help transform academic culture and practice toward routine data sharing.”
Authors of the article include Ida Sim, Michael Stebbins, Barbara E. Bierer, Atul J. Butte, Jeffrey Drazen, Victor Dzau, Adrian F. Hernandez, Harlan M. Krumholz, Bernard Lo, Bernard Munos, Eric Perakslis, Frank Rockhold, Joseph S. Ross, Sharon F. Terry, Keith R. Yamamoto, Deborah A. Zarin and Rebecca Li.
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.vivli.org and follow us on Twitter @VivliCenter.
More than 300 R packages and 250 Python packages are availableWe are delighted to announce the latest release of the Vivli platform included updates to the software and R packages available in the research environment.
We have updated the complete list of Software and R packages available in Vivli’s research environment to reflect these changes. Any researcher environments provisioned after March 14, 2020, will have this software included as standard and existing research environments can have these updated software and packages included upon request. Reach out to support@vivli.org for more information.
We hope you are well in this moment of uncertainty due to COVID-19.
We are reaching out at this time to let you know the steps we are taking to safeguard the well-being of both our employees and users.
• Staying in contact via remote technology whenever possible. We are a dispersed team primarily
concentrated in the Boston-area and are well-versed in the use of these remote technologies.
• Minimizing all non-essential business travel.
• Working closely with our vendors to minimize the potential impact of any user disruptions on the
Vivli platform.
• We will keep you updated as needed as the situation evolves.
In the meantime, please continue to direct all inquiries to support@vivli.org
Join Vivli and Privacy Analytics for a discussion of how both organizations help data contributors to share their data securely and protect patient’s privacy. The webinar will include discussions about the different approaches to anonymization and the value of a risk-based, quantitative anonymization approach. Learn more about how together we are building research communities to advance scientific research and creating trustworthiness through transparency. The webinar will be held on April 2nd at 10 am ET.
Our key topics include:
• Overview of the regulatory landscape
• Importance of data-sharing and secondary-use of data
• The fundamentals of anonymization
Presenters:
Rebecca Li, Vivli
Niamh McGuinness, Privacy Analytics
Dr. John Frew, the first Pioneer Award winner, from Rockefeller University, sat down for an interview with Vivli to share more about his research, the impact his findings are having on future clinical trial design and patient care, as well as his advice to researchers who were going to embark on a research project using individual-patient level data from completed clinical trials.
Congratulations on being named the first Vivli Pioneer Award winner. Can you tell us more about your research?
Thank you very much. Firstly, I’d like to acknowledge that this work is definitely a team effort. It would not be possible without our excellent statistical team: Neha Singh, Caroline Jiang and Prof Roger Vaughan; as well as our clinical research team Kristina Navrazhina, David Grand and Prof James Krueger, and, of course, Vivli and AbbVie, the data provider. Our research focused on Hidradenitis Suppurativa, which is a chronic inflammatory skin disease. Currently, there are very few approved therapies to treat it. There are also very few large-scale clinical trials that examine this condition. By going back and reviewing these large-scale clinical trials we can retrospectively look at the population with the condition we are researching.
The first aim of our research project focused on the utility of the outcome measures used in the completed clinical trials. We wanted to have a deeper analysis of the existing data sets on Hidradenitis Suppurativa prior to moving forward with expensive, long and large clinical trials and see if we need to reconsider the outcome measures used or develop new, or novel, outcome measures. We want to avoid the issue that have plagued clinical trials in this area that have failed due to their design.
The second aim of our research project was to look at the individual patient-level data to look at patient characteristics and see if they would inform response rates to therapy.
What were the results of your research?
In our recent publication in the Journal of the American Academy of Dermatology, our research showed that there were multiple outcomes measures for this disease and depending on which outcome measures were used, changed the efficacy of the treatment. We showed that additional confounding effects weren’t being taken into account in those outcome measures.
This research was able to provide an evidence base for the anecdotal comments we had heard from dermatologists and immunologists about the what they were observing in patients with Hidradenitis Suppurativa.
What difference do you hope your research will make?
Actually, I was at a conference in Europe last month and a half a dozen speakers were citing my research as the basis for re-thinking trial designs and the outcome measures used and whether multiple measures need to used or a new one developed to take these findings into account.
In addition, I had a European counterpart come up to me and say how important it was to not only be asking the right questions but to have a large, reliable data set to interrogate with these questions. Having all this data available via the Vivli platform is a key tenet to evaluating the epidemiological aspects of this condition. This is beyond valuable.
What’s next in your research?
These initial findings have validated our approaches to on-going analysis and confirmed that this work is more than “just re-analysis”. This work is highly useful with high utility and direct clinical applicability in the design of clinical trials and patient care.
Developing an evidence base for the treatment of Hidradenitis Suppurativa is really in its infancy and so being able to stimulate a discussion about the best way to design clinical trials using data at the individual patient-level is invaluable.
It has also opened up new lines of enquiry for our work, particularly in terms of mechanistic biochemical studies that we are doing in the lab with tissues and considering new variables.
That’s so exciting. Can you tell us more about the process of requesting data using Vivli?
I had never come across a concept such as the model that Vivli employs providing access in collaboration with companies who produced the data. It is a unique and fantastic opportunity. I found the user interface easy and logical to use. I cannot commend and recommend Vivli enough for the degrees of support and transparency throughout the whole process. It has been an absolute breeze. The data itself was of such a high quality. The clinical trials were developed to answer a very specific question but so much more can be done with the data beyond answering the original question it set out to address.
How did you find working in the research environment?
I think for me personally it was a bit of a learning curve. While I had a statistician that I worked with, it was largely me doing the coding from scratch. I was worried at first about the speed of access working in the secure research environment, but this was never an issue and I really appreciated the flexibility of being able to access the research environment from home and work.
I really loved the Chat function. It was so smooth to be able to ask the data providers and Vivli a question directly and to be able to get a response in a few hours was excellent.
What advice would you give to other researchers who want to request and analyze data via the Vivli platform?
Ask for help early and don’t try to bang your head against a brick wall. Make sure you work closely with your statistician every step of the way. I originally extracted some data out of the original data sets myself and had to go back and re-do it after discussions with the statistician.
I can see now why Vivli has taken the need for a statistician into account at the very beginning and have thought that out. You just have to trust their system and follow it through.
Vivli launched its first data analysis challenge shortly after our launch in an effort to generate interest and move data sharing forward. The Vivli Pioneer Award was conferred to the first approved 10 data requests that initiate analysis. The lead investigators of these data requests received $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.
The Vivli Pioneer Award recipients are:
John Frew, Rockefeller University
Vojtech Huser, National Library of Medicine/NIH
Akira Kimata, University of Tsukuba
Frederikus Klok, Leiden University Medical Center
Vivek Rudrapatna, UCSF
Changyu Shen, Beth Israel Deaconess Medical Center
Mirjana Stanic Benic, University Hospital Centre Rijeka
Sharon Straus, St. Michael’s Hospital
Diane van der Woude, Leiden University Medical Center
Michael Ward, National Institutes of Health
Vivli launched its first data analysis challenge shortly after our launch in an effort to generate interest and move data sharing forward. We are delighted to announce the first Vivli Global Data Sharing Innovator and our Vivli Pioneer Winners.
John Frew, Rockefeller University, is the first Global Data Sharing Innovator for his publication in the area of Dermatology. Dr. Frew will receive a travel award to present at the Vivli Annual Meeting on Nov. 18 in Amsterdam.
“Our congratulations to Dr. Frew,” said Rebecca Li, Vivli Executive Director. “We look forward to being able to name more Vivli Global Data Sharing Innovators in the near future.”
The Vivli Pioneer awards, granted to the first ten lead investigators whose data requests are successfully approved and have initiated their analysis, have also been named. They are eligible to receive $1,000. We are grateful to the Doris Duke Charitable Foundation for their initial grant in supporting these awards.
These winners are:
John Frew, Rockefeller University
Vojtech Huser, National Library of Medicine/NIH
Akira Kimata, University of Tsukuba
Frederikus Klok, Leiden University Medical Center
Vivek Rudrapatna, UCSF
Changyu Shen, Beth Israel Deaconess Medical Center
Mirjana Stanic Benic, University Hospital Centre Rijeka
Sharon Straus, St. Michael’s Hospital
Diane van der Woude, Leiden University Medical Center
Michael Ward, National Institutes of Health
View of summary of the research requests to learn more about these research proposals.