News & Events

Vivli launches Portals to support more effective data sharing and data reuse

Vivli is delighted to announce the launch of our new Portals feature, designed to highlight therapeutic areas of interest to the research community. One of our first portals focuses on available data relevant to HIV/AIDS, a priority area of research focus for NIH. 

We’ve designed Portals to make data from HIV/AIDS clinical trials more visible and discoverable. Vivli’s repository of data is built on nearly 7,000 research studies across a wide range of research areas, and includes a growing number being shared by individual researchers. This data repository provides a valuable resource for researchers to both share and access data that can be used to accelerate the progress of scientific research. 

Are you an HIV/AIDS researcher? We’d love to hear from you, whether you’ve got data to share or are interested in exploring our data resources to request. Explore our new HIV/AIDS Portal and find out more about how Vivli can support your research.

 

This is funded in whole or in part with Federal funds from the Office of AIDS Research, National Institutes of Health, 1OT2DB000003-01, awarded to Vivli.

Vivli CEO Rebecca Li to speak at the NIDDK Central Repository 20th Anniversary Workshop

Vivli’s CEO, Rebecca Li, will speak at the NIDDK Central Repository 20th Anniversary Workshop: Promoting Secondary Research to Accelerate Medical Breakthroughs and Innovation. This online event, hosted by the National Institute of Diabetes and Digestive and Kidney Diseases, will take place on September 19-20, 2023.

Li will participate as a panelist in a discussion session on ‘Supporting NIDDK-Funded Research and Expanding NIDDK’s Data Ecosystem’. This session will focus on real-world examples in which NIDDK-funded research is strengthening the data ecosystem and accelerating medical breakthroughs through secondary research, and is scheduled to run on Wednesday, September 20. NIDDK has been making data available to researchers in the Vivli repository since 2022.

The 20th Anniversary Workshop will review the NIDDK Central Repository program from its early beginnings to its current state, and engage a diverse range of experts from the research community to share experiences and explore future possibilities. Registration is open until Tuesday, September 19 – find out more and register on the event website

Vivli Researcher Spotlight: Dr. Neeraj Nerula on the use of Vivli’s platform to advance inflammatory bowel disease research


Dr. Neeraj Narula is an Associate Professor of Medicine and Staff Gastroenterologist at McMaster University in Hamilton, Ontario, Canada. His primary research focus is on inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. Dr. Narula is particularly interested in the endoscopic assessments of these diseases and understanding how to better quantify inflammation. He has devoted his efforts to devising ways to measure inflammation that provide meaningful prognostic value rather than arbitrary numbers.

One of Dr. Narula’s major contributions to research in this area has been the development of a scoring tool called the Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease (MM-SES-CD). This tool aims to better quantify inflammation in Crohn’s disease and provides higher weight to factors that are harder to heal. In contrast to previous methods, the MM-SES-CD shows great prognostic value and has shown potential in various clinical settings. Dr. Narula’s other interests involve data sharing platforms like Vivli. He values these platforms as a unique resource that younger investigators can access, helping them to answer key questions without the need for large-scale clinical trials. He encourages young researchers to leverage these resources to build their research profiles.

Dr. Narula believes that these platforms need some improvement in search functionality, making it easier for users to find specific trials. He also notes that learning how to interpret the data can be challenging initially; however, once this obstacle has been overcome, these platforms can be an invaluable resource. Dr. Narula’s ongoing research interests involve defining remission in Crohn’s disease and creating a similar tool for ulcerative colitis to the one he developed for Crohn’s disease. He is also working on validating the MM-SES-CD in unrelated datasets. He envisions these tools being incorporated into clinical guidelines in the future, ultimately improving patient care.

What led you to want to research this topic?

Inflammatory bowel disease (IBD) is a complex and multifaceted condition. While we have made significant strides in understanding IBD, there is still a lot to learn. The primary goal of this research was to delve deeper into patient response to various IBD treatments, to better personalize treatment plans and improve patient outcomes. The availability of an extensive dataset on Vivli allowed us to study patient responses in a more comprehensive manner than we might have been able to do otherwise.

What was your experience like in the process of requesting data using the Vivli platform? 

The process of requesting data through Vivli was straightforward and intuitive. The platform’s design made it easy to navigate, request the necessary data, and receive prompt responses. Vivli’s wealth of data provided an invaluable resource for our research

What is the current state of management in IBD? How was the data you accessed through Vivli able to help?

Current management of IBD largely involves a somewhat trial and error approach to medication. We aim to identify specific patient characteristics that predict response to particular treatments, enabling a more personalized, efficient approach to management. Access to data through Vivli allowed us to analyze a larger patient population and a wider variety of treatments than we would have been able to in a standard clinical setting.

How could your findings be used in future clinical trials on IBD? How can your findings be helpful in treatments for IBD patients?

We believe our research can help inform future clinical trials, guiding more efficient study design by highlighting potentially significant predictors of treatment response. Additionally, our findings can help clinicians make more informed decisions about treatment plans, ultimately benefiting IBD patients.

Would you use the Vivli platform again? What improvements would you recommend? 

Absolutely, the Vivli platform was instrumental in our research. In terms of improvements, perhaps a more detailed search functionality for the data could help researchers more quickly identify relevant studies. However, overall, the platform is user-friendly and efficient.

Please share any final comments about Vivli. What would you tell other researchers about doing this kind of analysis?

Vivli is a powerful tool for researchers in any medical field. The ability to access and analyze data from a vast array of clinical trials is truly invaluable. I encourage all researchers to consider using Vivli or similar platforms to enhance their studies, ensuring they have a clear research plan and question in mind to effectively leverage the available data.

Vivli celebrates publication of 200th public disclosure

Vivli celebrates 200 public disclosures

Vivli is delighted to announce publication of the 200th public disclosure resulting from the research team’s work with data from the Vivli platform. 

Rebecca Li, the Chief Executive Officer of Vivli, congratulates all the research teams who have utilized data from the Vivli platform to advance health research through the re-use of valuable clinical trial data. She also acknowledges the organizations, individuals, and thousands of trial participants who have generously shared their data, making this milestone possible.

The Vivli repository houses data from nearly 7,000 trials,  representing the contributions of 1.8 million clinical trial participants. On average, Vivli public disclosures are cited approximately 2.2 times per publication and appear in a wide range of highly-ranked academic journals. 

For more information about how to share and re-use data on the Vivli platform, please visit our Resources page.



President Announces Intent to Nominate former Vivli External Advisory Committee member as Director of the National Institutes of Health

Vivli enthusiastically congratulates Dr. Monica Bertagnolli on the White House announcement that it intends to nominate her as Director of the National Institutes of Health.

Dr. Bertagnolli has served as a long-time member on the Vivli External Advisory Committee.

“We are glad to see the intent to nominate Dr. Monica Bertagnolli to such an impactful role and we wish her all the best,” said Rebecca Li, Executive Director.

President Biden Announces Intent to Nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health

 

Vivli CEO Rebecca Li to Speak at FAIR Data Symposium at BIO-IT World Conference and Expo

Vivli’s CEO, Rebecca Li, will speak at the FAIR Data Symposium as part of the Bio-IT World Conference and Expo on May 16.

Li will discuss how to apply FAIR principles to the access of data from completed clinical trials, including using the appropriate technical and governance infrastructure. Platform architecture must include clear, computable metadata to facilitate findability and interoperability. Her talk will focus on Vivli as a use case and cover:

1) Principles that guided Vivli’s unique design choices as a FAIR trial data sharing platform

2) How Vivli balances the rights and interests of study participants and investigators with the needs of data requesters and the societal benefit of greater data sharing.

3) How Vivli has evolved with the needs of the ecosystem over time.

Learn more here.

Vivli is hiring a Clinical Research Manager

VIVLI, the Center for Global Clinical Research is seeking a Clinical Research Manager.

Vivli is a mission-focused non-profit and to help manage our continued growth, we are looking for a seasoned clinical research manager to join the operations team. The operations team supports researchers seeking to access datasets from contributors and provides support for data contributors.

Location: Remote, with a preference for East Coast or European working hours.

Responsibilities will include but not limited to:
• Manage day-to-day data request review process for specific requests.
• Work closely with Vivli end users to ensure success of the use of the platform
• Vivli platform QA
• Support the Vivli resource library.
• Lead in on-boarding new members
• Perform other duties when requested

Qualifications:
• Minimum 5 years prior experience managing data transparency processes, either at an existing repository, platform or as a data contributor
• 2-3 years experience with vendor management
• Experience in supporting researcher and/or data contributors in fulfilling data requests
• Understanding of clinical trials processes and/or clinical data management preferred
• Excellent written and oral communication skills and interpersonal skills
• Prior experience with process improvement a plus
• Computer proficiency in MS Office, Excel, PowerPoint, Sharepoint, Dropbox etc.
• Excellent organizational skills and attention to detail
• Ability to manage projects and resources
• Bachelor’s degree in the health profession, science, IT or business field

To apply, send a cover letter and CV to hr@vivli.org.

Breaking News — Vivli announces the AMR Surveillance Open Data Re-use Challenge, funded by Wellcome, EOI due June 30

Vivli has launched the Vivli AMR Surveillance Open Data Re-use Challenge, funded by Wellcome. The data challenge aims to stimulate and support the innovative re-use of antimicrobial resistance (AMR) surveillance data available in the AMR Register.

This Challenge provides an opportunity for multidisciplinary teams to win prizes by using high-quality industry AMR surveillance data to answer pressing research questions. The data will be shared through the AMR Register.

A series of prizes can be won by research teams from any discipline who find new insights in the data and contributes to the fight against antimicrobial resistance.

What prizes can be won?
There are five monetary awards:
• Grand Prize Award – $20,000
• 4 awards – $10,000 (each) in the categories of Innovation and Impact

Winning teams will additionally be provided with funding towards expenses for ECCMID 2024 if an abstract is accepted.

Sign up to the data challenge Slack Channel to be notified when the challenge is open and to keep updated about the latest information and details about this data challenge.

What’s involved?
Teams are invited to register and submit a short summary of the research they intend to undertake with the data (and Expression of Interest or EOI) by May 10. The EOIs will be reviewed and teams will be given access to the data for a 30-day window, during which solutions must be submitted.

These submissions will be reviewed by a panel of judges and finalists selected. Finalists will have the opportunity to pitch their idea to a panel of judges via Zoom and the prize winners will be chosen.

Winners will be invited to submit a project abstract to ECCMID 2024.

Vivli Researcher Spotlight: Dr. Elena Myasoedova on accessing clinical trial data to advance research and the possibilities for using machine learning as a tool in clinical support for people with rheumatoid arthritis

Elena Myasoedova, M.D., Ph.D., is a clinical rheumatologist with specialty interest in inflammatory arthritis. She is an associate professor of medicine and epidemiology and clinical practice, and leads research in rheumatology and specifically inflammatory arthritis at the Mayo Clinic. Dr. Myasoedova’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Individualized Prediction of Treatment Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning Approach”. Their completed research has been presented to the rheumatology research community at conferences and in publications including Annals of the Rheumatic Diseases. She sat down with Vivli to tell us more about accessing clinical trial data to advance her research, and the possibilities for using machine learning as a tool in clinical support for people with rheumatoid arthritis.

Please tell us a little bit more about your research – what led you to want to investigate this particular topic?
In patients with rheumatoid arthritis, methotrexate is a medicine that is used very commonly, and frequently is the first medicine and the most common medicine used in combination later on during the disease course. The challenge that we are facing in rheumatology in general is that we do not have individualized prediction of response to treatments. This means that we use a trial and error approach to treatments; we start patients on medications that are generally effective and safe, and then if a patient does not respond, we upgrade to a different medicine. Because most of the medicines that we use take weeks and months to show their effects, it’s important to understand early on if a person is likely to be a responder. That would help to save time and potentially save some unwanted side effects for the patient, and also help us to be more proactive and helpful.

For this specific study, we looked at clinical markers or clinical predictors of response to methotrexate. We found more than 1400 patients from 13 randomized trials. A total of 775 patients from 4 RCTs were included in the study, and we monitored their response across a six-month timeframe. We further evaluated whether people who did not respond to methotrexate and had some moderate to high disease activity at 12 weeks – who out of this population would respond by follow-up at 24 weeks. We also found a couple of markers for that: specifically if there was a drop in DAS28 sat rate from baseline to 12 weeks of at least 1 point, then it was predictive of then achieving remission or low disease activity at 24 weeks. Otherwise the chances were slim.

We developed this algorithm, and externally validated it using two independent trials with good results. I think that these findings advance the understanding of who are the most likely responders, and how we should discuss with patients their likelihood of response at the very start of their treatment.

Are you hoping that this is going to change the clinical approach? Has it already had an impact in clinical approaches to working with people who have arthritis?
This particular study, and similar studies would probably change the way we discuss this treatment with a patient; changing the treatment approach is a very complex task that probably has to come through the association guidelines.

Is there anything specific that you’d like to say about what working with the dataset in Vivli enabled you to do that you might not have been able to do otherwise?
It was actually a very good experience for us to work with Vivli datasets. It provided longitudinal data on patients who were users of methotrexate but not other medicines, and there were hundreds of these patients available from the trials. So it’s a fairly good dataset to work with, and it had multiple data points longitudinally. Also, at each point, there were multiple clinical points collected, so it was fairly comprehensive.

Do you have any advice that you would give to other researchers who might be interested in accessing this type of data using a platform like Vivli?
The most important advice is to put together a comprehensive proposal with a plan right off the bat, to make sure that the timeline is feasible and that the question that they want to address is feasible with the available data – just to make sure that they are not over-expecting or under-planning. I think it’s most important to ensure that the study question matches the data set.

Have you had feedback about your research and findings?
This research has been presented at several conferences, and the comments have mostly been positive, acknowledging the need for developing such algorithms.

T1D exercise data RFP from Helmsley Charitable Trust due the end of this month

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program has launched an initiative to support innovative and practicable solutions to help people with type 1 diabetes (T1D) exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley supported a research collaboration centered on two large observational exercise studies in people with T1D: one in adults (T1-DEXI) and one in children (T1-DEXIP). More than 500 people took part in the adult study, and another 250 in the pediatric study. Both studies were recruited and conducted fully remotely by design, enabling full monitoring and data collection which was unimpeded by COVID-19 pandemic restrictions.

The data from these studies include information about types of physical activity, heart rate, insulin use, CGM, diet, and genetics. The research collaboration collected and organized the observational data to maximize interoperability, and Helmsley has partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available. Sharing study data publicly will enable a range of researchers to access and explore the data from a variety of perspectives and research specialties.

In addition to facilitating public access through the Vivli platform, Helmsley has also opened a request for proposals (RFP) to support researchers, clinicians, and data scientists interested in analyzing the data and testing novel solutions in people with T1D. The RFP aims to fund projects that will improve the understanding of how exercise impacts T1D and that will provide people with T1D and their healthcare providers practical management solutions and clinical guidelines. The overarching purpose of this initiative is to move real-world data towards real-world solutions.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Researchers interested in exploring the T1D dataset on Vivli in order to prepare concept notes for submission can search data publicly available through Vivli’s search portal, and submit a data request using the standard process. Complete information about the RFP, including key dates and submission criteria, is available on The Helmsley Charitable Trust site.

Deniz Dalton, Program Officer in T1D at Helmsley, said, “People with T1D face many burdensome challenges in their daily lives, including complex decisions around exercise, diet, monitoring glucose levels, and administering insulin. We are excited to make this data publicly available and to launch this RFP, to advance the understanding of how exercise affects glucose management, and ultimately to help create real-world solutions to challenges faced by people with T1D around exercise.”

For more information, please watch Dalton’s presentation on this initiative at the Vivli 2022 Annual Meeting, or contact Vivli User Support directly at support@vivli.org with any questions