News & Events

ONO joins Vivli as a Member to Share its Data

“We are delighted to have ONO join as a member of Vivli, particularly given its rich and long history,” said Rebecca Li, Vivli CEO. “We look forward to working with the team at ONO to share their data to meet their data sharing commitments.”

Ono believes that sharing clinical study data and results with researchers, healthcare professionals, and patients contributes to the promotion of scientific studies and medical research, thereby leading to public benefits. Ono shares clinical study data in accordance with the guidelines stipulated in the “IFPMA Principles for Responsible Clinical Trial Data Sharing” presented by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) dated January 15, 2018, as well as in compliance with industry guidelines including Good Publication Practice, applicable laws, and regulation.

For more information about the conditions for accessing ONO data, please visit their member page. For additional information about Membership in Vivli, learn more here.

DNDi joins Vivli to Share its Data

The Drugs for Neglected Diseases initiative (DNDi), has joined Vivli as a member to share its valuable datasets.

“We are delighted to include these important studies from DNDi on Vivli,” said Rebecca Li, Vivli CEO. “Vivli is excited to work with DNDi to make it easy and efficient for researchers to access these data.”

DNDi is an international, not-for-profit research and development organization. It discovers, develops, and delivers treatments for neglected patients around the world. Its treatments are affordable and patient-friendly – and have already saved millions of lives.

“Vivli is a leading data-sharing platform and DNDi is committed to open science,” said Dr Craig Tipple, Medical Director at DNDi. “By working together to share DNDi’s clinical study data, we can optimize the public health and scientific benefits of our research, meet our ethical and scientific obligations for data transparency, and, we hope, accelerate the development of new medicines for neglected diseases.”

For more information about the studies DNDi will share on Vivli, please visit their member page. For additional information about Vivli membership, learn more here.

Vivli Webinar: The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of Concern

Please join us for a Vivli webinar at 5pm CEST / 11am EDT / 8am PDT on Friday, April 12th as we discuss recent developments in data privacy laws and their impact on data sharing.

REGISTER

Over the past few weeks there have been significant U.S. executive and congressional actions related to restricting transactions, data transfers, and certain types of contracts with China, other countries of concern (e.g., Russia), and individuals and businesses connected with these countries. Principally, this includes President Biden’s Executive Order (“EO”) on bulk sensitive personal data transfers and the corresponding U.S. Department of Justice Advance Notice of Proposed Rulemaking (“ANPRM”), the unanimous passage by the U.S. House of Representatives of the Protecting Americans’ Data from Foreign Adversaries Act, and the passage of the BIOSECURE Act by a critical Senate Committee.

All three of these developments, if finalized, will have important impacts on the sharing of data and biospecimens with China and certain other jurisdictions that have been labeled “countries of concern.” In this presentation, Ropes & Gray partner, David Peloquin, will walk through these different proposed regulations and legislation, focusing on the implications they each may have for research data sharing. He will also discuss the different timelines and comment periods for the EO and ANPRM, as well as the current status of each of the pending pieces of legislation.

Speaker:

  • David Peloquin, Partner, Ropes & Gray

Learning objectives for this session include:

  • Understanding the basics of the EO, the ANPRM, the BIOSECURE Act and the Protecting Americans’ Data from Foreign Adversaries Act
  • Understanding how each of these proposed regulations or pieces of legislation may affect research data sharing with China and other countries of concern
  • Understanding the potential timelines for implementation of each of these proposed regulations and pieces of legislation

REGISTER

Vivli Co-Founder Named to 2024 STATUS List

Vivli is delighted to congratulate our co-founder and Board member Dr. Ida Sim on her inclusion in StatNews’ 2024 STATUS List.

The STATUS List recognizes “50 influential people shaping the future of health and life sciences across biotech, medicine, health care, policy, and health tech.”

Dr. Sim is a pioneer in using the power of technology to advance medical research and practice. In addition to her role as professor and chief research informatics officer at the University of California, San Francisco, Dr. Sim has been instrumental in developing key software infrastructure underpinning the digital medicine domain, establishing data-sharing standards, and grappling with the technical challenges of improving access to digital health resources for everyone.

“We are thrilled to hear of Dr. Ida Sim’s inclusion in the STATUS list,” said Rebecca Li, Vivli CEO. “Her efforts and commitment to improving access to medical data have had enormous impacts on health research.”

Read more about the 2024 STATUS List

UCLA joins Vivli to Support its Investigators to share data

“Vivli is delighted to have UCLA join us a member,” said Rebecca Li, Vivli CEO. “We look forward to working with its faculty and staff to support them in their data sharing efforts.”

For more information about the conditions for accessing UCLA data, please visit their member page. For additional information about Membership in Vivli, learn more here.

Vivli Researcher Spotlight: Reusing Data from a Completed Clinical Trial to Inform Guidelines

In a recent study led by Dr. Sarah Nevitt, a senior research associate at the University of Liverpool, a team of researchers examined the effectiveness of various antiepileptic drugs (AEDs) used as monotherapy for people experiencing seizures due to epilepsy. Epilepsy, a common neurological disorder, results from abnormal electrical discharges in the brain, causing recurrent seizures. Typically, around 60% to 70% of individuals with epilepsy achieve longer-term remission, often shortly after beginning treatment with antiepileptic drugs.

Dr. Nevitt and her team sought to compare the performance of 12 different AEDs in terms of treatment failure, remission, and occurrence of first seizures among both children and adults with focal onset or generalized tonic‐clonic seizures. They analyzed data from an extensive collection of clinical trials encompassing more than 22,000 participants, incorporating individual patient data from various studies using a network meta-analysis.

The analysis revealed some key insights. Older drugs like phenobarbitone and phenytoin demonstrated better seizure control for both focal and generalized seizures but had poorer long-term retention rates compared to newer medications such as lamotrigine and levetiracetam. Sodium valproate emerged as the top choice for achieving control and remission of generalized tonic‐clonic seizures, although it might not be suitable for everyone, especially people of childbearing age, due to associated risks.

These findings, published in the Cochrane Library, have already influenced the update of UK guidelines in 2022, providing immediate impact on the treatment of individuals newly diagnosed with epilepsy in the UK. In a recent conversation with Vivli, Dr. Nevitt highlighted that these results are guiding the approach to epilepsy treatment, emphasizing the importance of considering both efficacy and potential side effects when selecting appropriate medications for individuals experiencing seizures.

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.



Vivli Researcher Spotlight: Assessing Clinical Trial Data on Cardiac Risk in Type 2 Diabetes Treatment

Dr. João Sérgio Neves is an endocrinologist, based in the Faculty of Medicine of the University of Porto and São João Hospital in Porto, Portugal. Dr. Neves’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Albiglutide and Cardiovascular Outcomes in Type 2 Diabetes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use”. The team’s completed research has been presented in publications including the Journal of the American College of Cardiology. Dr. Neves sat down with Vivli to tell us more about accessing individual participant data to advance his research, and the potential for combination therapy to reduce the risk of cardiovascular events in patients with Type 2 Diabetes.

Could you tell us a little bit about your research? What got you interested in the particular area of research that you carried out working with Vivli?

So I am a clinical endocrinologist; I do clinical research in the field of Endocrinology. I have a particular interest in the effects of endocrine diseases on cardiovascular risk and on cardiac function. My main areas of research have been obesity, diabetes, and pre-diabetes. Previous studies conducted by our team have explored the effects of GLP-1 receptor agonists in patients with diabetes, both with and without heart failure. One of the questions that was still unanswered from the literature was whether the benefits of GLP-1 receptor agonists were still observed in those that were already treated with SGLT2 inhibitors. These two classes of drugs are known to be protective from a cardiovascular perspective for patients with Type 2 Diabetes. However, the two classes were developed and the clinical trials were conducted in parallel. So when clinical trials of GLP-1 receptor agonists (AMPLITUDE-O trial and Harmony Outcomes study) were conducted a bit later and included participants that were already treated with SGLT2 inhibitors at baseline. The authors of the AMPLITUDE-O trial had already performed a sub-analysis evaluating the effects of the GLP-1 receptor agonists in patients treated with SGLT2 inhibitors. Given the relevance of further exploring the combination of GLP-1 receptor agonists with SGLT2 inhibitors, our group requested the Harmony Outcomes study from Vivli. The we also performed a meta-analysis combining the results of the Harmony Outcomes study with the results from the AMPLITUDE-O trial. So there are two trials that we included that evaluate the effects of GLP-1 receptor agonists and included some patients using SGLT2 inhibitors and we wanted to know if this data could help us understand if both drugs when combined can give further cardiovascular protection to patients with Type 2 Diabetes.

And having come to the conclusions that you did – that there may be further reduction in cardiovascular risk but that more clinical trials with combination therapy are required – have the findings from this made any impact in terms of research practice that you’re aware of, since the findings have become available?

So since the findings became available, there has been some interest from other doctors contacting us on how to interpret our findings. We are very cautious and we believe that further data and dedicated clinical trials are necessary to thoroughly evaluate this drug combination. However, acknowledging that these trials might take several years to be conducted, we also recognize that our existing data could assist physicians in making informed decisions about utilizing this combination in the interim. We believe that  the results of the Harmony Outcomes trial, in combination with the AMPLITUDE-O trial, favor the possibility that the combination of both drugs is protective from a cardiovascular perspective.

Interestingly, in the same month our paper was published in the Journal of the American College of Cardiology, the European Society of Cardiology published an updated guideline on the treatment of patients with Type 2 Diabetes and cardiovascular disease, and they recommended that patients with Type 2 Diabetes and cardiovascular disease should be treated with both drugs. They did not yet cite our paper because it was published just before publication of the guideline, but they do cite, for example, the AMPLITUDE-O trial. So I believe that our data will reinforce this recommendation; and we see that the field of treatment and prevention of cardiovascular disease in Type 2 Diabetes was already moving in the direction of our findings. But as there was only one study evaluating this combination, we think that our results will be very important for supporting the use of GLP-1 receptor agonists in combination with SGLT2 inhibitors.

Can you talk a little bit about using the data that was available through Vivli; what were you able to do using that data that you were not able to do otherwise?

The type of analysis we aimed to conduct could theoretically be performed using observational data. However, utilizing observational data poses significant challenges due to numerous confounders, particularly when assessing the effects of therapeutic interventions involving drugs. This limitation is well-documented, and such an approach would lack robustness, potentially raising more questions than providing answers. I think that the most interesting thing about the analysis that we performed was that this was a clinical trial that was already performed; the data was already available.

When we analyzed the data we worked with the authors from the primary paper; we got in contact with the authors of the primary analysis and we planned this analysis together. Our interactions with the original authors were invaluable in interpreting the data, given their familiarity with it. This collaborative effort resulted in an interesting analysis and yielded important results.

Can you talk a little bit about your experience of working with the Vivli platform – the processes and technology and what that was like?

I think that the process was quite easy, the instructions are clear. We know that there is always some type of bureaucracy that is involved, but that’s part of how it works, because we are dealing with data from patients. Of course it is anonymized data but I think that’s not different from what I was used to with other types of shared data. , The process works quite smoothly.

The thing that I feel that was a little bit different from our previous experience with secondary analyses, was the use of a platform for analyzing the data outside of our computers. Nevertheless, we successfully conducted our data analysis, and the data was also accessible within the remote computer, allowing us to execute the entire analysis seamlessly.

And how did you find out about Vivli and the opportunity to reuse shared data in general?

We had previously conducted analyses through the secondary analysis of existing data, utilizing platforms such as BioLINCC , which incorporates data from studies sponsored by NIH. Our awareness of Vivli stemmed from mentions in papers that disclosed their data sharing approaches, indicating that access could be facilitated through Vivli. This was my first personal experience using Vivli, and I must say that I find the work undertaken by the Vivli team truly remarkable. Your efforts contribute significantly to the future of research and the enhanced utilization of already collected data.

How has the direction of your own research been affected by the research that you did on this project? Has it affected what you’re doing or changed your direction in any way?

I believe it has provided clarity on the next steps to enhance knowledge in this field. In our team, we recognized that addressing whether the treatments were additive or not would be a pivotal question. If we discovered that the combination did not yield additional risk reduction, we needed to understand which drug to select for specific patients. With the results we obtained, our focus shifted towards understanding how to improve access to these drugs and assessing their effectiveness in other populations, particularly in the earlier phases of Type 2 Diabetes and even pre-diabetes. As we design new clinical trials, we are already incorporating the insights gained from this analysis.

Would you use the Vivli platform again? Are there any changes or improvements that you would recommend to how it works?

Certainly, the experience was highly positive, and I look forward to working again with Vivli in the future. One overarching improvement (that’s not specific to Vivli) would be to expand access to even more data. I do believe that the data is very valuable and that it is very important to share the data from large clinical trials. The type of study that we analyzed is probably the most relevant that should be shared – of course with a very specific and detailed analysis plan and with all the regulations that are needed in this context. Considering the substantial resources and time invested in these clinical trials, there is often a wealth of data that remains untapped. Many crucial analyses may not have been conducted and researchers not primarily involved in the clinical trial may be able to identify these questions and answer them using the data from that trial. Therefore, it is important to facilitate access to this valuable resource.

So my main recommendation is to try to increase even further the number of studies that are available. Of course this also depends on the companies that own the data and the drugs that are being evaluated. But our analysis could not be performed without the sharing by GSK, so we are also thankful for their contribution to Vivli and for the sharing of the data.

And is there any advice you would give to other researchers who are at the beginning of the process of requesting or using shared data?

My main advice is to have a very specific question that the researchers want to answer; develop a detailed analysis plan; and submit the request to the Vivli platform. While the process may take some time, it is not overly complex. With patience and adherence to the required steps, one can successfully obtain access to the data. I firmly believe that enhancing the utilization of the Vivli platform and increasing access to data from large clinical trials will significantly improve the quality of knowledge across various fields in medicine.

Event: Shaping the next 10 years in data sharing: Building on the gains made and looking ahead to the next 10 years in advancing human health

Please join Vivli at the National Academy of Medicine in Washington, DC on November 16, 2023 in Washington, D.C. for a strategic meeting to collectively reflect on the seminal 2015 IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk to see how far we have come and chart a course to meet the challenges and opportunities that lie ahead.

PROCEEDINGS RECORDINGS

Session topics will focus on the following areas:

  • Welcome by Victor J Dzau, NAM President
  • IOM Report – 2015 Recommendations and Challenges Ahead
  • The value of data sharing realized –Use Cases
  • Credit and incentivizing the academic culture
  • Key technologies that will influence data sharing (machine learning, AI)
  • Regulations and policies to promote data sharing and re-use
  • Shaping inputs and directions for the next 10 years

We look forward to welcoming researchers, data contributors, publishers, funders and other interested stakeholders to this event as we work together to set a direction for data sharing and develop an action plan for the next 10 years.

This event is free, but registration is mandatory. Please register as soon as possible, as in-person space is limited. Virtual attendees will be able to view and ask questions of presenters. For virtual attendees, participation in the breakout groups and direction setting sessions will be limited. Please email support@vivli.org with any questions.

Agenda

 

Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the National Institutes of Health (NIH), will join as the lunchtime keynote speaker on Thursday, November 16th. Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person.

Dr. Bertagnolli is the second woman to lead the NIH on a permanent basis. Previously, Bertagnolli served as Director of the National Cancer Institute and has served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.

The 2015 IOM Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk Recommendations and Challenges ahead
Should we collectively set a new “north star” for the next 10 years?

Moderator: Bernard Lo, M.D., Professor of Medicine Emeritus, University of California San Francisco

  • Jeffrey M. Drazen, M.D. NEJM Group Editor, The New England Journal of Medicine
  • Professor Arti K. Rai, Elvin R. Latty Professor of Law, Duke Law
  • Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder
  • Joanne Waldstreicher, M.D., Independent Director, Becton Dickinson and Structure Therapeutics; Former Chief Medical Officer, Johnson & Johnson (retired); Faculty Affiliate, Division of Medical Ethics, New York University School of Medicine

The Value of Data Sharing Realized
This session will focus on real-life case studies that show the fruition of efforts to share data and its impact on science.

Moderator: Murray Stewart, M.D., Chief Medical Officer, Rhythm Pharmaceuticals, Inc., Vivli Board member

  • Ricardo Jorge de Oliveira Ferreira, Ph.D., Auxiliary Researcher at the Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL)
  • Richard Liwski, Chief Technology Officer and Director, Critical Path Institute’s Data Collaboration Center
  • Rebecca Li, Ph.D., CEO and co-founder, Vivli
  • Sarah Nevitt, Ph.D., Senior Research Fellow, Centre for Reviews and Dissemination, University of York
  • Ronald Summers, M.D., Ph.D., Senior Investigator, Imaging Biomarkers and Computer-Aided Diagnosis Laboratory, NIH Clinical Center

 

Credit and Incentivizing the Academic Culture
With the recent policy announcements by the White House and the newly updated NIH Data Management and Sharing Policy, movements are afoot to prompt academic researchers to share. What more can be done to encourage academic researchers to share their data by leveraging incentives?

Moderator: Barbara Bierer, M.D., Faculty Director, MRCT Center, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Director Regulatory Foundations, Ethics and Law, Harvard CTSA; Vivli co-founder

  • Elliott Antman, M.D., Director, Harvard Postgraduate Program in Clinical/Translational Science, Professor of Medicine, Harvard Medical School
  • Daniel Ernest Ford, M.D., M.P.H., Director & Professor of Medicine, Senior Associate Dean for Clinical and Translational Research, Johns Hopkins Institute for Clinical and Translational Research
  • Benjamin Pierson, Deputy Director, Enterprise Data, Bill & Melinda Gates Foundation

 

Key Technologies that will Influence Data Sharing (Machine learning, AI)
What role with key technologies such as Generative AI and other key technological advances play in data sharing? What are the key motivating factors and obstacles that will need to be addressed?

Moderator: Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder

  • Joshua C. Mandel, M.D., Chief Architect for Healthcare, Microsoft; Lecturer on Biomedical Informatics, Harvard Medical School
  • Philip Payne, Ph.D., FACMI, FAMIA, FAIMBE, FIAHSI, Director, Institute for Informatics, Data Science and Biostatistics (I2DB); Chief Data Scientist and Associate Dean of Health Information & Data Science; Washington University School of Medicine in St. Louis
  • Jane Perlmutter, M.B.A., Ph.D., President and Founder, Gemini Group Consultancy

Regulations and Policies to Promote Data Sharing and Re-Use
Given recent shifts in national policies to promote data re-use as well as efforts by publishers to promote data reuse, what more can be done by regulators, national governments, publishers and other key actors to advance data sharing and subsequent re-use?

Moderator: Michael Stebbins, Ph.D., President Science Advisors. Vivli Board Chair

  • Steven Kern, Ph.D., Executive Director, Global Health Labs
  • Michael Lauer, M.D., Deputy Director for Extramural Research, NIH Office of the Director
  • Deven McGraw, J.D., M.P.H, LLM, Lead, Data Stewardship and Data Sharing, Invitae
  • Sharon Terry, M.A., Chief Executive Officer, Genetic Alliance

PROCEEDINGS RECORDINGS

Servier joins Vivli to Share its Data

“We are delighted to have Servier, which is such an innovative organization that focuses strongly on research and development,” said Rebecca Li, Vivli CEO. “We look forward to working with the team at Servier to share their individual patient-level data to advance science.”

At Servier, we draw strength from our independence. We believe being free to make our decisions and adopt a long-term vision enables us to fulfill our vocation as a Group committed to therapeutic progress to serve patient needs. It makes us unique in the pharmaceutical industry.

For more information about the conditions for accessing Servier data, please visit their member page. For additional information about Membership in Vivli, learn more here.