Please find linked above the proceedings and a recording of the meeting. This includes separate recordings of all panels and the keynote sessions from Dr. Robert Califf, FDA Commissioner and Dr. Monica Bertagnolli, NIH Director.
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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.
Stanford joins Vivli as a member to make it easier for its investigators to meet new NIH data sharing policy
“Vivli is delighted to have Stanford join with our other academic members to provide a simple, secure way for its researchers to meet the new NIH data sharing policy,” said Rebecca Li, Vivli Chief Executive Officer. “We look forward to working with the Stanford research community to make the data from clinical trials accessible to other researchers to continue to drive forward science.”
Senate confirms former Vivli External Advisory Committee member as Director of the National Institutes of Health
Vivli enthusiastically congratulates Dr. Monica Bertagnolli on her recent confirmation as Director of the National Institutes of Health.
Dr. Bertagnolli will become 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. Dr. Bertagnolli has also served as a long-time member on the Vivli External Advisory Committee.
“We are thrilled to hear of Dr. Monica Bertagnolli’s confirmation to such an impactful role. We wish her every success and look forward to witnessing her continued achievements,” said Rebecca Li, CEO.
Vivli Researcher Spotlight: Dr. Yizhe Xu on analyzing clinical trial data to inform development of machine learning tools
Yizhe Xu is a Postdoctoral Researcher at Stanford Center for Biomedical Informatics Research, Stanford University. Dr. Xu’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Applying machine learning tools to personalize dabigatran treatment decisions”. The team’s completed research has been presented to the research community at conferences and in publications including the Journal of Biomedical Informatics. She sat down with Vivli to tell us more about accessing individual participant data to advance her research, and the potential for machine learning tools to support more accurate estimation and evaluation of heterogeneous treatment effects.
Tell us more about your research. What is the current state of management in your public disclosure topic?
Our final paper has been published in the Journal of Biomedical Informatics as of July 2023.
What led you to want to research this topic?
First of all, treatment effect heterogeneity is an important question that informs clinical decision making given the fact that treatment effects often vary across patients. Thus, accurate estimation of individual treatment effects helps to tailor treatment to patient characteristics and maximizes their benefits. However, it has been realized by a wide group of researchers that estimating treatment heterogeneity is challenging, so we summarized the best practices and advanced methodologies and showed a case study on how to carefully estimate heterogeneous treatment effects using the RE-LY and RELY-ABLE trials.
What difference do you hope your research might make, either in the field or for patients? How has it moved forward the treatment of patients?
We hope our case study provides clear instructions and serves as a concrete example for clinical researchers, and that by following our suggestions, they will be able to avoid possible false discoveries of treatment heterogeneity and prevent misleading findings. The improvement of research quality will directly benefit everyday clinical care in the sense that patients will truly benefit from personalized treatment selection if there is treatment heterogeneity and can be estimated reasonably well. On the other hand, we can save the clinicians’ time and efforts on considering personalized treatment when the treatment effect is essentially uniform across patients.
How could your findings be used in future clinical trials in your disease area?
The statistical methods we have summarized and the guidance we provide on how to select a method and evaluate the model performance can be applied to clinical trials in any disease area. However, for observational studies, practitioners need to consider adjusting for confounding, for instance, using methods such as propensity score matching or weighting.
How did the data you accessed through Vivli help you in answering your research question?
Very well. The RE-LY trial enables a case study for us to demonstrate the principled approach we proposed for estimating heterogeneous treatment effect in a real study. The RE-LY study has a large data size, and the fact that it is an RCT helps to simplify the task of treatment effect estimation.
What was your experience like in the process of requesting data using the Vivli platform?
It was an okay experience – we had some difficulties in resolving issues related to the DUA, which made us wait for quite a while, but we were able to get the access eventually.
Would you use the Vivli platform again? Would you recommend Vivli to others? What improvements would you recommend?
Yes, especially if I think some of the unique data sources on the Vivli platform will help to answer particular research questions of my interest. I will also recommend Vivli to others for the same reason. I would recommend simplifying the data requesting process to shorten the waiting time, as well as expanding user autonomy – particularly that users do not need to make a request every time they want to export results.
What advice would you give to other researchers about doing this kind of analysis?
We encourage researchers to understand their data first, then select the most suitable statistical approaches based on that knowledge. After that, we suggest interpreting findings based on the results from multiple estimators that are weighted by their performance, which is evaluated using several different metrics. Please also see our paper for our detailed recommendations.
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 Updates Platform to Ensure Researchers Who Contribute Data on Vivli Receive CRedIT on ORCID profiles
Vivli has updated its platform so that researcher teams who submit and store their clinical research data can now receive CRedIT on their ORCID profiles. This change was made to incentivize researchers to share their data. Future secondary analysis publications that are derived from the initial data, will be cited and tracked in Vivli.
With this change, Principal Investigators can ensure that their researcher teams receive CRedIT on their ORCID profiles.
Researchers can then go to the Vivli platform to see secondary citations from their data.
Rebecca Li, Vivli’s CEO said “This platform update is innovative in allowing researchers to directly track secondary research that uses their data and have this utilization reflected publicly in their ORCID profile. Researchers and institutions can use this information for future grants and we hope this will be adopted as part of the promotion and tenure process. We are very grateful to Wellcome who made this work possible through a grant to Vivli.”
There’s more on Vivli than just clinical trial data
Did you know there’s more on Vivli than just clinical trial data? The majority of our repository of data comes from clinical trial data, but also includes significant numbers of platform trials, observational studies, and real-world evidence resources.
Vivli’s repository of data from nearly 7,000 research studies is available to search freely. Enter any relevant keyword and you’ll get a listing of pertinent studies of different kinds. Here are some recent search results using common keywords for studies that are not clinical trials:
Observational: 198
Natural history: 26
Platform trial: 420
Explore our How To Guides to learn more about accessing and searching for data with Vivli. If you’d like to take your research further, you can get in touch with us for more information about specific studies or requesting access to data.
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.