News & Events

Vivli CEO Rebecca Li to participate in panel discussion for Harnessing the Potential of Patient-Level data in Clinical Trials     

Vivli’s CEO, Rebecca Li, will speak on Day 3 at the Global Clinical Trials: Technology & Innovation webcase series. This online event will take place on May 14-16, 2024. Li will participate as a panelist in a discussion session on ‘Harnessing the Potential of Patient-Level data in Clinical Trials.’

Explore the practical benefits of patient-level datasets in clinical trial as industry experts discuss strategies for implementing fully consented patient data and its impact on trial outcomes. The panel will be held on Thursday, May 16th, 5pm CEST / 4pm BST / 11am EDT. Learn more and register here.

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.

Vivli Researcher Spotlight: Rethinking Rheumatoid Arthritis Management: The Dual Target Strategy

Rheumatoid arthritis (RA) poses a significant challenge due to its chronic nature and impact on joint health. While treatments have evolved, achieving remission remains elusive for many patients. Using a dataset from the Vivli repository, Dr. Ricardo Ferreira and a team of researchers delved into examining the assessment criteria for remission in RA, shedding light on the limitations of current approaches and proposing a new model—the dual target strategy.

The current standard of treatment is the Treat-to-Target (T2T) approach, which aims for remission or low disease activity. Dr. Ferreira’s team questioned the reliance on a single criterion, the patient global assessment (PGA/PtGA), included in composite measures for determining remission. Their study, drawing from extensive clinical trial data, notably revealed that 19% of patients failed to attain remission based solely on this patient-reported assessment, leading the team to explore a more comprehensive model. In a recent conversation with Vivli, Dr. Ferreira highlighted the research’s key finding: the lack of significant difference in radiographic outcomes between patients classified as “PGA-near-remission” versus those in full remission. This challenges the established understanding of remission incorporating the patient global assessment.

The research team has proposed a dual target strategy, which integrates patient-reported outcomes with objective measures like inflammation status and joint counts to assess inflammatory status and guide immunosuppressive therapy management. The second target (disease impact) would be assessed by informative patient-reported outcome measures, other than PGA. By assigning equal significance to subjective experiences and clinical data, this innovative approach proposes a new benchmark for remission in RA management. Moreover, it has the potential to guide both pharmaceutical and nonpharmacological interventions.

It is anticipated that the dual target strategy has a more patient-centric approach; integrating subjective experiences with objective clinical markers holds promise for improving treatment efficacy and enhancing patient outcomes. With key RA researchers expressing interest in this model, the dual target strategy could significantly change both RA management, and the experience of patients navigating this complex condition. A pragmatic, multicenter, randomized controlled trial is currently being prepared to test this strategy.

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: 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.



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.

Read more here.

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.”