News & Events

Vivli Researcher Spotlight: Dr. Fasihul Khan on the potential for biomarkers to predict outcomes for people with pulmonary fibrosis

Fasihul Khan, M.D., Ph.D., is a consultant at Glenfield Hospital, University Hospitals of Leicester NHS UK. Dr. Khan’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “A systematic review and individual patient data meta-analysis of physiological biomarkers in idiopathic pulmonary fibrosis”. The team’s completed research has been presented to the research community at conferences and in publications including American Journal of Respiratory and Critical Care Medicine. He sat down with Vivli to tell us more about accessing individual participant data to advance his research, and the potential for biomarkers to predict outcomes for people with pulmonary fibrosis.

Please tell us more about your research – what led you to want to research this particular topic?

So my area of interest is pulmonary fibrosis, which is a condition causing scarring of the lungs. Pulmonary fibrosis is a relatively rare condition, and therefore the number of studies in this area are limited, although expanding rapidly.  I was keen to synthesize some of the existing information that was already available. I wanted to perform a systematic review, specifically looking to see whether there are blood biomarkers that can predict outcomes in patients with diagnosed pulmonary fibrosis. When I started searching the literature, it very quickly became apparent that there were several published studies, but actually the data and the way the studies were reported were very heterogeneous.  Individually the studies yielded inconsistent results, utilized data-dependent thresholds, and frequently did not adjust for confounders. Therefore, I sought individual participant data which helped overcome these limitations and enabled robust data analyses to be performed leading to reliable conclusions. 

Could you talk about what it was like to work across multiple data-sharing platforms; how did you handle that?

This was not straightforward! I created summary estimates from each study separately on the different platforms in Vivli and in CSDR, then imported them manually onto my own database. I then used additional software to pool the summary estimates. Having the data all  in one place would have saved me a lot of time and stress!

Not a lot of researchers have the perseverance to do what you did. What advice would you give to researchers before they start off? Things you wish you’d known before you started?

I think it’s important to consider the project as a whole. It is highly likely the process will take much longer than you think, and that’s not necessarily any individual or organization’s fault. You need to have a clear understanding with contingency plans for each stage, and give yourself plenty of time! Be clear about your research question, and whether individual participant data are likely to improve your research, before committing to the additional effort. Speak to others who have been through the process of acquiring individual participant data, and your institution to understand timescales for data sharing agreements as these are likely to be time consuming and potential limiting factors. 

Once you were able to access the individual patient data, were you able to get past the reporting limitations and find what you needed? 

Absolutely; once we had the raw data, we were able to perform our analysis and produce some very meaningful results, which we have  subsequently published in two journals. The first was a blood biomarker paper in the European Respiratory Journal which was the first blood biomarker study in pulmonary fibrosis to utilize this approach, and provides robust estimates of the association between matrix-metalloproteinase 7 and disease progression.

The second paper was published in the American Journal of Respiratory Critical Care Medicine. In this paper, we looked at change in FVC which is a lung function measurement used to assess progression in pulmonary fibrosis. All interventional clinical trials measure FVC as an endpoint – typically at 12 months, but patients have additional FVC measurements at baseline, 3, and 6 months. The purpose of our research was to evaluate whether short term changes in FVC i.e. over three-months, are associated with overall mortality. In other words, can we shorten clinical trials by finding an earlier signal than the 12 months FVC change that is currently accepted by regulators. Since the association between short term FVC change and mortality was not reported in any clinical study, we needed the individual participant data to model this association. Indeed, we were able to find that three-month FVC change is associated with mortality, and perhaps more importantly a treatment effect could be observed between treatment and placebo arms at three-months. The findings of this study have been well received by the research community, and have already been adopted into the design of an adaptive trial in IPF. Lots of hard work, but worth it as the results are likely to generate further research which ultimately will hopefully impact patients in a positive manner!  



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.

Vivli Board names Rebecca Li CEO

Vivli announced that its Board of Directors has promoted Rebecca Li to the position of CEO. Li previously held the position of Executive Director and has been with the Vivli since its founding when it launched as a project from the MRCT Center of the Brigham and Women’s Hospital and Harvard.

“Rebecca has overseen the extraordinary growth of Vivli from the start and we are excited that she will continue to lead Vivli through the next phase of growth as we aim to go even further in our mission to make clinical trial available for research. She has demonstrated herself to be an exceptional team leader and strategic thinker with a clear vision for how we will develop globally in the coming years,” said Dr. Michael Stebbins, Vivli’s Board Chair.

“I am privileged to lead Vivli and envision further expanding our successful platform technology into Europe and Asia as we enter our next phase of innovation and growth” said Dr. Rebecca Li.

Vivli was founded in 2018 as a non-profit organization that is currently the largest individual participant-level (IPD) data sharing platform focused on sharing clinical trial data serving the international research community.

 

Projects at Vivli

Vivli works with many partners and funders to further its vision to advance human health through clinical research data sharing, to respect and honor the contributions of clinical research participants.

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.

 

 

Enquiries about Vivli Member Studies

To enquire about a study not listed on Vivli or for additional study information not included in a study listing, please complete the below fields. To request multiple studies from the same Member, please list the all study IDs in the “Study ID” field. Please note you must enter at least one study in the Study ID field to submit your enquiry. If you have enquiries for multiple Members, please submit a new form for each Member.

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.

If a Member responds that a study is available, a data request will need to be submitted via the Vivli platform. In order to request access to study data, you must become a Vivli user. Additional information on how to get started is available in our resources section.


    Individual participant-level dataClinical documents (data dictionary, protocol, etc.)Summary-level data

    (e.d. Sponsor ID, NCT ID, Eudra CT ID) (Note: if you have multiple studies from the same data contributor, please list all study IDs)


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    Vivli Committees

    The Vivli Steering Committee comprises representatives from Vivli members. This group includes institutional data contributors from academia, governmental, industry, and non-profit organizations and meets regularly to discuss operational, governance, and policy issues.

    The Vivli External Advisory Committee brings together a diverse group of influential leaders with a commitment to data transparency. These leaders provide knowledge and insights based on their experience and expertise in their respective fields on a broad range of issues related to governance, implementation, and strategic planning. This external perspective supports Vivli’s growth as an institution.

    • Sergio Bonini, Italian National Research Council (CNR), Institute of Translational Pharmacology
    • Jeffrey Drazen,  New England Journal of Medicine 
    • Dave Evans, CDISC
    • Nina Hill, Hill Scientific and Public Affairs
    • Karmela Krleza-Jeric, Impact Observatory, MedILS  
    • Young-Joo Lee, Johns Hopkins University
    • Bernard Lo, UCSF
    • Joshua Mann, VHL Alliance
    • Jan McGonagle, Amoskeag Health
    • Vasee Moorthy, World Health Organization 
    • Brian Nosek, Center for Open Science 
    • Amy Nurnberger, MIT
    • Jane Perlmutter, Gemini Group 
    • Larysa Rydzewska, MRC Clinical Trials Unit at UCL
    • Lon Schneider, University of Southern California
    • Carolyn Shore, National Academies of Sciences (NAS) Observer
    • Karla Soares-Weiser, Cochrane
    • Catrin Tudur Smith, Liverpool University
    • Megan von Isenburg, Duke Medical Center Library and Archives
    • David Vulcano,  HCA Healthcare
    • Daoxin Yin, Peking University, Health Science Center