Vivli’s Director of Strategy and Operations, Julie Wood, will be presenting at the 2020 European Medical Writers Association 2020 Virtual Symposium on 6 November 2020. The event’s theme is Research Integrity & The Medical Communicator: What We Do When Know One is Watching.
Wood’s talk is entitled Responsible Data-Sharing to Improve Research Integrity. View the full agenda
September 3 at 11AM ET
This 60-minute webinar will explore the emergence of synthetic data, a privacy preservation approach to protect individual patient data. Top experts will explain what synthetic data is, when and how to deploy this approach and share case studies about the successful utilization of using synthetic data and future applications of synthetic data.
Topics include:
• Highlight issues faced by data contributors wishing to share data from rare diseases concerned about privacy issues
• Putting synthetic data in context with other privacy preservation approaches
• Case studies of successful use of synthetic data and how it applies to clinical research
Webinar attendees will have the opportunity to ask questions of the panelists.
Moderators:
Ida Sim and Marcia Levenstein, Vivli
Presenters:
Patrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra
Vivli Executive Director, Rebecca Li, will take part in a panel discussion as part of Data Sharing to Accelerate Therapeutic Development for Rare Diseases hosted by Duke and the FDA. Her session will focus on platform analytics tools to support data sharing and drug development for rare diseases.
The Duke-Margolis Center for Health Policy, through a cooperative agreement with the U.S. Food & Drug Administration, is convening a two-day public meeting on August 18th and 19th, to discuss the importance of data sharing for accelerated therapeutic development in rare disease as well as considerations for sustaining and leveraging a robust data sharing infrastructure to support innovative rare disease trial design. The meeting will explore several topics including:
Please see the event page for more details and to register for the event.
“We are delighted to welcome Taiho Pharma 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.
Taiho Pharma is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. As a company, they are determined to deliver new drugs that maximize health benefits to patients around the world.
For more information about how Taiho shares data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.
Members of Vivli, the Center for Clinical Research Data, announce today their commitment to share their COVID-19 trials through Vivli.
Members who have committed to sharing their data on the COVID-19 portal, a dedicated search function within Vivli for COVID-19 include Eli Lilly & Company, Regeneron, Roche, Takeda. Additionally, Cochrane, Covid Collaboration Platform, UCB, and the Wellcome Trust expressed their support of these efforts.
“Coronavirus is currently the most searched term on the Vivli platform and the new search experience is coupled with an accelerated process for data sharing. We believe that now, more than ever, sharing the individual participant data that underpins trial results is vital to driving forward both new science as well as scientific consensus,” said Rebecca Li, Vivli Executive Director.
“Vivli will continue to waive the fees for sharing for any interventional trial related to COVID-19 and to make the process as easy as possible. You don’t have to be a member to share your data using Vivli. We can and do share data from researchers from industry, academia, and non-profits. We have also partnered with vendors who can anonymize these datasets who have offered to anonymize the datasets waiving their normal fees. Vivli is doing all it can as part of the wider ecosystem of the health research community who are collaborating and coming together to do everything we can to find a treatment or vaccine for COVID-19.”
In March, Vivli announced the launch of a COVID-19 portal for sharing data trials. All member and user fees are waived. Vivli also partnered with anonymization vendors to waive the fees for anonymization of the data from COVID trials. In addition, the Wellcome Trust Independent Review Panel will provide an accelerated review process within three business days of receiving a request.
“We are committed to supporting timely and equitable access to data, and hope this streamlined service will produce important new discoveries from researchers who analyse the available data,” said Georgina Humphreys, from the Wellcome Trust IRP secretariat.
Vivli provides researchers with a secure, easy-to-use online platform to archive and share clinical trial data across all diseases and research entities. Vivli also allows researchers to combine and analyze data from multiple trials using state of the art tools.
Statements from Vivli Members and Supporters
“Roche is proud of its commitment to patients, and sharing COVID-19 study data through Vivli’s globally-respected platform allows researchers to leverage data to gain new insights at a time of critical need,” said Jeff Helterbrand, Global Biometrics Head at Roche. “We encourage the pharma industry, academia and research community to embrace the opportunity to responsibly share data for the benefit of all.”
“The evolving COVID-19 pandemic is profoundly impacting our lives, and places tremendous strain on healthcare systems and society at large. So, UCB is proud to support the work that the Vivli team is undertaking to drive collaboration and data sharing, as we believe this will enhance disease understanding, generate new insights, and may help develop new treatments to benefit patients worldwide,” said Professor Dr. Iris Loew-Friedrich, chief medical officer and executive vice president, UCB
“The COVID Collaboration Platform (CovidCP) is delighted to partner with Vivli to help academic researchers working on similar COVID-19 interventions collaborate and share data. Aggregating evidence across similar trials is crucial for understanding the best strategies to prevent and treat COVID-19, and Vivli will make it possible for us to help researchers design and run analyses to do just that.” – Elizabeth Ogburn from the CovidCP Executive Committee and Johns Hopkins University. https://covidcp.org/
Editor in Chief of the Cochrane Library, Karla Soares-Weiser said, “The pandemic represents a significant threat to global health, high quality evidence to inform decision making is needed urgently. Now, more than ever, fast, shared access to trial data is needed. Cochrane is pleased to support this initiative from Vivli as it promotes research integrity, transparency and acknowledges the value of timely and responsive production of evidence.”
Join Vivli, COVID Collaboration Platform (CP) and TransCelerate BioPharma for a discussion of how these organizations are working to support academia, foundations and industry to collaborate and share data for COVID-19 trials.
The webinar will discuss the work that each organization is taking to support their stakeholders to more quickly collaborate, share and analyze COVID-19 data to accelerate science.
The webinar will be hosted on July 9 at 9 am Pacific/12 pm ET/6 pm CET.
Key topics include:
Webinar attendees will have the opportunity to ask questions of the panelists.
Presenters:
Rebecca Li, Vivli
Elizabeth L. Ogburn, Barbara Bierer, COVID Collaboration Platform
Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc
“We are thrilled to welcome Roche as a member of Vivli and to be able to list their studies on the platform,” said Rebecca Li, Vivli Executive Director.
Roche is a global health care leader in the areas of oncology, immunology, infectious diseases and neuroscience. Through innovation in diagnostics and targeted treatments, Roche aims to improve the health and quality of life of patients around the world.
“Roche is delighted to be joining Vivli and to work in partnership with them to share our data through the Vivli platform,” said Jeff Helterbrand, Global Biometrics Head at Roche. “Especially during this critical time of public health challenge, we welcome the opportunity to work with a trusted partner.”
For more information about how Roche shares data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.
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.
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