News & Events

Vivli Researcher Spotlight: Examining serological status to better understand treatment response in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disorder, which primarily affects the joints and is characterized by inflammation and pain. RA most commonly affects the hands and wrists, but can also affect other parts of the body. There is currently no cure for RA, but treatment options have improved considerably in recent years with the development of new therapies and treatment strategies.

Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are well established as a standard treatment for RA, used to slow down progression of the disease through broad restriction of the immune systems. Biologic DMARDs (bDMARDs) take a more targeted approach, but it is unclear if it is equally effective across the spectrum of types of RA. In particular, the serological status of people diagnosed with RA may be linked to long-term outcomes. Also,  based on differences in associations with genetic and environmental risk factors, seropositive and seronegative disease are presumed to have different underlying pathophysiological mechanisms. However, whether serological status may also affect treatment responses to biological disease-modifying anti-rheumatic drugs (bDMARDs) is not completely clear. 

In a recently completed study, Dr. Kaoru Takase-Minegishi and colleagues undertook a meta-analysis based on a systematic literature review including data from 28 randomized controlled trials (RCTs). The research team’s goal was to investigate whether the efficacy of bDMARDs differs in seropositive RA patients (seropositive) compared to those classified as seronegative. Some of the study participants were also receiving csDMARDs, while other were treated bDMARDs exclusively.

The research findings indicate that seropositivity was not associated with a better response to bDMARDs, regardless of whether patients were also receiving csDMARDs. Other outcomes mostly showed no significant difference between the groups, and efficacy was generally comparable between seropositive and seronegative patients for a range of treatment protocols. 

Using the Vivli platform enabled the research team to include previously unpublished data, the first opportunity to perform meta-analysis on this complete dataset. Previously unpublished data are included in the Supplementary Material, available online alongside the article recently published in the journal Rheumatology. This research provides a very important additional perspective to the data reported from observational studies thus far, uncovering essential differences. 

Read more about Dr. Takase-Minegishi’s research:

Effect of rheumatoid factor and anticitrullinated peptide antibody on the efficacy of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis (Vivli Research Requests 4922, 3274)
The Impact of Autoantibodies (RF and ACPA) on the Efficacy of Biological Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis: Meta-analysis of Randomized Controlled Trials (Abstract, American College of Rheumatology Convergence 2022)
The impact of autoantibodies (RF and ACPA) on the efficacy of biological disease-modifying antirheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Annals of the Rheumatic Diseases)
The impact of autoantibodies on the efficacy of biological disease-modifying anti-rheumatic drugs in rheumatoid arthritis: meta-analysis of randomized controlled trials (Rheumatology)

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: 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.



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.

Public Disclosures

Vivli aims to advance human health through clinical research data sharing. One of the key ways we support this is through the Vivli platform, which facilitates data sharing. Vivli platform metrics as of 26 Sep 2024. The metrics will be updated every two months.

These tables provide details of approved research proposals that have published or presented their results.

Independent Review Panel

An experienced independent consultant acts as the secretariat for the Independent Review Panel (IRP). Data contributors can choose to have an independent, neutral party oversee the review of requests by accessing the esteemed Independent Review Panel who will review research proposals based on their merit.

For more information, please review the Independent Review Panel Charter. Read more about the IRP members.

 

 

Webinars, Publications & Presentations about Data Sharing

VIVLI WEBINARS

View Vivli’s webinars at your convenience by clicking on the links below:

DateWebinarSpeakers
April 2024The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of ConcernRebecca Li, Vivli
David Peloquin, Ropes & Gray
April 2023Recent Developments in Data Privacy Laws and their Impact on Data SharingRebecca Li, Vivli
David Peloquin, Ropes & Gray
Katherine Wang, Ropes & Gray
February 2023Submitting Your NIH Data Management and Sharing Plan using VivliAnne Seymour, Johns Hopkins University
Amy Nurnberger, Massachusetts Institute of Technology
John Borghi, Stanford University
Rebecca Li and Julie Wood, Vivli
November 2022Applying the SAFE Data Standard to Securely Share Clinical Trial DataLuk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Stephen Bamford, Head of Clinical Data Standards & Transparency, Janssen Research and Development
Aaron Mann, CEO, Clinical Research Data Sharing Alliance

Moderated by:
Marcia Levenstein, Senior Advisor, Vivli
October 2022Mind the Data Sharing Gap: Navigating sponsor policies and data protection methodologiesLuk Arbuckle, Chief Methodologist, Privacy Analytics (an IQVIA company)
Liz Roberts, Senior Director, Data Policy and Privacy Lead, UCB

Moderated by:
Aaron Mann, CRDSA CEO
June 2022How Vivli Promotes Discoverability of Partner Platforms and RepositoriesIshwar Chandramouliswaran, NIH
Dawei Lin, ImmPORT
Ida Sim, UCSF and Vivli
June 2021Sharing Academic Clinical Research DataIda Sim, UCSF and Vivli
Dan Ford, Johns Hopkins University
Susanna Naggie, Duke University
Kim Serpico, Harvard T.H. Chan School of Public Health
Ara Tahmassian, Harvard University
March 2021Clinical Trial Data Sharing and Machine Learning ResearchIda Sim, UCSF and Vivli
Abigail Gregor, Ropes & Gray
Daniel Freshman, Ropes & Gray
September 2020Synthetic Data: How to preserve privacy of participants when sharing clinical dataPatrick Cullinan, Bluebird Bio
Khaled El Emam, Replica Analytics
Michael Lesh, Syntegra
July 2020Accelerating Science in the Age of COVID-19: Three Key Data InitiativesRebecca Li, Vivli
Elizabeth L. Ogburn, Dr. Barbara Bierer, COVID Collaboration Platform
Janice Chang, Cara Rinaldi, TransCelerate BioPharma, Inc
April 2020 Data Sharing and Data Anonymization: the Vivli-Privacy Analytics Partnership Rebecca Li
Niamh McGuinness
February 2020Future Directions: Real World Data, Real World Evidence and Clinical TrialsDr. Ida Sim
Marcia Levenstein
Dr. Gregory Pappas
Dr. Jack Mardekian
November 2019Credit for Data SharingDr. Barbara Bierer,
Ms. Heather Pierce
October 2019Why Data Sharing and Data Standardization MattersMr. David Bobbitt MSc, MBA
Dr. Ida Sim, MD, PhD
Dr. Rebecca Li
May 2019Top five questions small and mid-size companies should ask before embarking on a data sharing programDr. Rebecca Li
March 2019 Keys to Submitting a Quality Research Proposal to a Data Sharing PlatformMs. Cynthia Holas,
Dr. Sonali Kochhar,
Dr. Georgina Humphreys,
Dr. Joe Ross,
Ms. Ginger Gamble, MPH.

February 2019 Informed Consent and Data Sharing Dr. Barbara Bierer ,
Dr. Rebecca Li ,
Mr. David Peloquin,
Dr. Stephen Rosenfeld
January 2019How to Share and Request Data on VivliDr. Ida Sim, MD, PhD
November 2018 IPD Meta-Analysis Webinar Dr. Sarah Nevitt

PUBLICATIONS ABOUT DATA SHARING

Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse

Rebecca Li, Nina Hill, Catherine D’Arcy, Amrutha Baskaran, Patricia Bradford, "Health Data Sharing Platforms: Serving Researchers through Provision of Access to High-Quality Data for Reuse", Health Data Science, vol. 2022, Article ID 9768384, 3 pages, 2022
COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic

Kristina Larson, Ida Sim, Megan von Isenburg, Marcia Levenstein, Frank Rockhold, Stan Neumann, Catherine D'Arcy, Elizabeth Graham, David Zuckerman, Rebecca Li. COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic. Contemporary Clinical Trials. 2022.

Sharing Health Data: The Why, the Will, and the Way Forward A Special Publication from the National Academy of Medicine

Whicher, D., M. Ahmed, S. Siddiqi, I. Adams, M. Zirkle, C. Grossmann, and K. L. Carman, Editors. 2021. Health Data Sharing to Support Better Outcomes: Building a Foundation of Stakeholder Trust. NAM Special Publication.Washington, DC: National Academy of Medicine.

New NonProfit Aims To Bring Data Transparency To Researchers
Move clinical trial data sharing from an option to an imperative
Timely access to trial data in the context of a pandemic: the time is now.

Li R, Wood J, Baskaran A, et al. Timely access to trial data in the context of a pandemic: the time is now. BMJ Open 2020; 10:e039326. doi: 10.1136/bmjopen-2020-039326
COVID-19 trials: declarations of data sharing intentions at trial registration and at publication

Li, R., von Isenburg, M., Levenstein, M. et al. COVID-19 trials: declarations of data sharing intentions at trial registration and at publication. Trials 22, 153 (2021). https://doi.org/10.1186/s13063-021-05104-z
Data Sharing Goals for Nonprofit Funders of Clinical Trials

Coetzee T, Ball M, Boutin M, Bronson A, Dexter DT, English RA, Furlong P, Goodman AD, Grossman C, Hernandez AF, Hinners JE, Hudson L, Kennedy A, Marchisotto MJ, Myers E, Nowell WB, Nosek BA, Sherer T, Shore C, Sim I, Smolensky L, Williams C, Wood J, Terry SF, Matrisian L
Data Sharing Goals for Nonprofit Funders of Clinical Trials J Particip Med 2021;13(1):e23011 doi: 10.2196/23011 PMID: 33779573

PRESENTATIONS

May 10-11, 2021"Considerations for Sponsors when using a Data Sharing Platform" and panel, "Balancing Sharing Results and Data Whilst Protecting Participants Data Privacy" at InformaConnect Clinical Data Disclosure, Transparency & Plain Language SummariesJulie Wood
Rebecca Li, PhD
May 5, 2021"Data Sharing in a Time of Pandemic", a webinar with Front Line GenomicsRebecca Li, PhD
April 12, 2021"Implementation of Data Sharing platforms and How Researchers are Utilizing these Platforms to Further their Research.", a webinar with the HRB-Trials Methodology Research NetworkRebecca Li, PhD
March 26, 2021"Acceleration of Research and Implications for Research Transparency." Center for Biomedical Research Transparency Summit SeriesIda Sim, MD, PhD
January 19, 2021"Data Sharing of Rare Disease Data – Challenges and Rewards." PHUSE Data Transparency Winter MeetingRebecca Li, PhD
December 11, 2020 "Vivli: A Global Clinical Trials Data Sharing Platform." dkNET webinarIda Sim, MD, PhD
November 6, 2020"Responsible Data-Sharing to Improve Research Integrity." European Medical Writers Association 2020 Virtual Symposium Julie Wood
October 16, 2020"Privacy Incoherence in Medicines: The Confluence of Corporate Trade Secret, Government Non-Transparency, and AI Mediated Erosion of Patient Privacy." Northeastern University's Center for Law, Innovation and Creativity Annual ConferenceRebecca Li, PhD
August 18, 2020"Platform Analytics Tools to Support Rare Disease Drug Development." FDA convening hosted by the Duke-Margolis Center for Health PolicyRebecca Li, PhD
April 24, 2020"Sharing, Discovering and Citing COVID-19 Data and Code." National Library of Medicine (NLM) at the National Institutes of Health (NIH)
Ida Sim, MD, PhD
February 11, 2020"Vivli Clinical Research Data Sharing: Share. Discover. Innovate." NIH Workshop on the Role of Generalist Repositories to Enhance Data Discoverability and Reuse, Bethesda MD
Ida Sim, MD, PhD
October 25, 2019 “Finding New Solutions to Problems and Concerns in Clinical Data Sharing – Outcomes from Datathon."DIA Future of Evidence WorkshopRebecca Li, PhD
October 10, 2019 "Clinical Trial Data Sharing and Reuse: A New Reality for Researchers." Clinical Data Interchange Standards Consortium WebinarIda Sim, MD, PhD
Rebecca Li, PhD
September 27 2019 "Preparing for clinical trial data sharing and re-use: the new reality for researchers." NIH Collaboratory Grand RoundsRebecca Li, PhD
Frank Rockhold, PhD
September 19, 2019“The Vivli Experience in Sharing Clinical Trial Data Globally.”OHRP Exploratory Workshop: Privacy & Health Research in a Data-Driven WorldRebecca Li, PhD
June 2019“Symposium SY13: Data sharing and responsible conduct of research: sharing industry experiences as part of the research transparency environment."World Conference in Research Integrity, Hong KongRebecca Li, PhD
March 27, 2019“Vivli: A Global Secure Data-Sharing Platform for Participant-Level Clinical Trial Data." Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
January 30, 2019“The Disclosure and Data Sharing Lifecycle.” CBI Clinical Data Disclosure and Transparency Conference, Philadelphia PAJulie Wood
Thomas Wicks (TrialScope)
October 25, 2018 "Sharing and Using Deidentified Individual Participant Data (IPD)." DIA Global Clinical Trials Transparency Conference, LondonRebecca Li, PhD
March 13, 2018“Vivli: A Global Secure Data Sharing Platform for Participant-level Clinical Trial Data.” American Medical Informatics Association Summit, San Francisco CAIda Sim, MD, PhD
November 17, 2017 “Acceleration of Innovation to Overcome Intractable Diseases." Academic Research Organization’s 2nd Global Network Workshop, Austin TXIda Sim, MD, PhD

Enquiries about Vivli Member Studies

To enquire about a study not listed on Vivli or to obtain additional information not included in a study listing, please submit an enquiry through the Vivli Platform. To submit an enquiry or request access to study data, you will need to create a Vivli Platform account. Additional information on how to get started is available in our guide to requesting studies on Vivli.

For more information on Vivli Members, please visit the Member Page. Some Members may require that enquiries be submitted via their own portals. Enquiries will be answered at the discretion of the Member. Please note that most members do not share studies where the primary completion date has not yet been reached.

Have a question and need to get in touch with the Vivli team? Contact us.