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Category: News

Using Vivli to Meet NIH Data Sharing Plan Requirements

Ida Sim, Technical Lead, Vivli

As increasing numbers of funders introduce requirements for data sharing plans, researchers have to develop a new skill: how to create and fulfill a data sharing plan.

Many data sharing plan requirements from funders have similar requirements. While the specifics vary somewhat based upon the type of data and how the researcher plans to share clinical data once it is completed, the general questions to ask about data sharing mandates are:

  • WHO do these requirements apply to?
  • WHAT data do you plan to share, and in what format?
  • WHEN will it be made available, and for how long?
  • WHERE will it be accessible?
  • HOW can it be accessed, i.e. under what conditions or restrictions?

Vivli is an innovative new clinical research data sharing platform with a robust search engine that has been created to meet the needs of researchers who use clinical research data worldwide. Using the Vivli platform, researchers can access de-identified data from thousands of completed clinical trials. However, Vivli also has another benefit to researchers: providing them an easy, straightforward means of meeting their data sharing requirements. Unlike many data repositories or registries, Vivli offers a tool for safely sharing individual-level participant data (IPD), rather than just summary results. This helps clinical researchers meet their data sharing requirements from key funders, such as the NIH. For an example of how a researcher could use Vivli to meet NIH requirements, see the chart below:

NIH Requirements How can Vivli help?
Who? Investigators submitting a research application requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003 are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible.

Vivli can help researchers meet their NIH data sharing requirements.

Learn more about sharing data on Vivli here.
What? The precise content of the data-sharing plan will vary [but may include]:

  • the format of the final dataset,
  • the documentation to be provided,
  • whether or not any analytic tools also will be provided.
 As a neutral platform, Vivli lets data contributors decide which data to share.

  • You can securely share individual de-identified participant data on Vivli.
  • Vivli also allows researchers to store and share study related documents, code and tools.
When? Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing.
  • Vivli will store data and make it available for as long as it retains scientific utility.
  • Once you upload your data in a simple drag-and-drop process, it is made available for sharing.
Where? The NIH allows researchers to choose the mode of data sharing, including repositories like Vivli.
  • On the Vivli platform, your data is accessible to everyone globally increasing the visibility and impact of your data.
  • Vivli will manage all requests for your data directly, reducing the administrative burden of data sharing.
How? Applicants who are planning to share data may wish to describe briefly:

  • whether or not a data-sharing agreement will be required
  • a brief description of such an agreement
  • the criteria for deciding who can receive the data whether or not any conditions will be placed on their use
 Vivli can make it possible for your data to be downloadable or can be accessible in a secure research environment.

  • All data shared on Vivli is subject to a Data Use Agreement.
  • The conditions of sharing are made transparent on the Vivli website.

Data sharing plans may be included in the grant proposal. Under Vivli Resources on our website, we have created an NIH Data Sharing Template  to help you meet data sharing requirements. If you have any questions about this blog, or how to use Vivli to meet data sharing requirements, please contact the Vivli team via email to support@vivli.org.

Vivli contributors release new commentary on data sharing and our platform launch

The research community is increasingly aware of the need for clear and actionable plans for sharing research data following completion of clinical trials. Key stakeholder groups have called for improving public access in order to increase the pace of research and discovery, and honor the contributions of patient involvement in clinical trials. A new commentary, published November 19 in the National Academy of Medicine’s Perspectives journal by a team of authors comprising the Vivli team and contributors, describes Vivli’s work to make responsible data sharing a reality through the design and launch of the Vivli platform earlier in 2018.

Moving Data Sharing Forward: The Launch of the Vivli Platform

IPD Meta-Analysis Webinar

An introduction to individual patient data meta-analysis using the Vivli platform

Vivli was pleased to host an engaging webinar presentation on November 15 from Dr. Sarah Nevitt, University of Liverpool.

The recorded webinar is available online and publicly accessible.

Access this webinar to learn:
• What is the difference between IPD meta-analysis and aggregate meta-analysis?
• When is IPD meta-analysis the best approach to use?
• How can a platform like Vivli facilitate my research?

Dr. Nevitt’s presentation includes specific examples of IPD meta-analysis and practical aspects of retrieval of IPD from different and sources, including pharmaceutical sponsored trials and publicly funded trials. She also addresses the question of what to do when not all IPD is available for analysis.

Presenter bio:
Dr. Sarah Nevitt has a background of Mathematics and Statistics; with a BSc from the University of Liverpool in Mathematical Sciences with a European Language, an MSc in Medical Statistics from the University of Leicester and a PhD in Biostatistics from the University of Liverpool. Her doctoral thesis examines the impact of data sharing and data transparency on the conduct of individual participant data syntheses. Within her role at the Department of Biostatistics, she supports Cochrane authors on as the Statistical Editor of the Cochrane Epilepsy Group and she has authored eight IPD reviews in Epilepsy. She also has experience of Health Technology Assessment, Single Technology Appraisals, analysis of clinical trials and statistical consultancy.

Why AbbVie is a member of Vivli

Research and innovation are the cornerstones of AbbVie’s business. The company advances leading-edge science through a dynamic and collaborative approach, enabling them to find better solutions for treating the world’s most challenging diseases. AbbVie focuses on discovering, developing and delivering medicines in therapeutic areas where it has proven expertise and can make an impact. This includes Immunology, Oncology, Neuroscience, Virology and General Medicine.

A Commitment to Data and Information Sharing

There are important health benefits in making clinical trial data and information available to health care providers, researchers, patients and the general public. Thus, AbbVie has adopted national and international principles and standards regarding the sharing and publication of clinical trials data and information.

“We are committed to responsible and ethical clinical trial data sharing and believe in its potential to advance scientific knowledge to improve patient care,” said Rob Scott, M.D., chief medical officer and vice president, global pharmaceutical development, AbbVie. “Our collaboration with Vivli supports this commitment and we look forward to a successful partnership and broad uptake of this unique and global platform.”

Find out more about how to access and request AbbVie studies on Vivli.

An Exclusive Conversation with Dr. Khaled El Emam and Rebecca Li – Increasing Access to a Global Good

Vivli presents a conversation between Vivli Executive Director Rebecca Li and Privacy Analytics founder and CEO Dr. Khaled El-Emam. The two discuss the development and features of Vivli, and how global health research benefits from the Vivli-Privacy Analytics partnership.

Use this link to view the free webinar recording:

Increasing Access to a Global Good

About Vivli’s partner, Privacy Analytics:

Privacy Analytics enables business leaders to deploy transformative data strategies, giving them an edge in the hyper-competitive race for innovation and new revenue streams. On the web: www.privacy-analytics.com.

Why the Helmsley Charitable Trust supports Vivli

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. The mission of Vivli aligns directly with this goal.  

“Every day, we are reminded of the urgent need to accelerate medical research. Too many people around the world are suffering from disease and need more effective treatments,” said Stephanie Cuskley, CEO of the Helmsley Charitable Trust, a founding member of Vivli. “Partners like Vivli offer a unique opportunity for research institutions to maximize their impact by sharing data and working together to propel new scientific discoveries forward.”  

Dr. Gina Agiostratidou, Program Director for the Helmsley Charitable Trust’s Type 1 Diabetes (T1D) Program, which aims to advance research, treatments, technologies, and services that improve the life of people with type 1 diabetes, participated as a panelist at the Vivli Platform launch event in July of 2018, demonstrating her organization’s commitment to furthering the reach and benefit of data sharing.  

 

Cochrane and Vivli formalise partnership aimed at accelerating global medical research

Vivli to use Cochrane vocabulary to power Vivli’s search

Cochrane and Vivli are pleased to announce their partnership aimed at helping health researchers move faster toward new treatments and cures. The first phase of the partnership has been to work together to use the Cochrane ontology to power the Vivli search. Clinical trials included or cited on the Vivli platform are annotated using the Cochrane PICO ontology and vocabulary.

Vivli is a non-profit organization that promotes clinical trial data sharing via a platform designed to serve all elements of the international research community. Cochrane members were invited to try out the Vivli beta website prior to its launch in July.

“This partnership will make it easier to discover and access clinical trial data on the Vivli platform,” said Julie Wood, Vivli’s Director of Strategy and Operations. “Cochrane’s ontology will improve discoverability of data on the Vivli platform and advance quality research. We hope this relationship will continue to grow as we work to make it easier for Cochrane researchers to access clinical trial data. This new partnership will further promote Cochrane’s mission of promoting evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesized research evidence.”

Chris Mavergames, Head of Informatics & Technology (IT) Services said, “Cochrane is delighted to be working with Vivli to improve access to clinical trial data, and to put our pioneering work in Linked Data into practice for the benefit of the research community worldwide.”

The Vivli platform helps researchers worldwide to discover, share, and analyze data from clinical trials, regardless of who sponsored the research or where the research took place.

Li Presents at the 2018 Innovative Approaches to Clinical Biomarker Validation conference – Boston, MA

Executive Director Rebecca Li joined 2018 Innovative Approaches to Clinical Biomarker Validation conference as a presenter, demonstrating for the attendees the tools Vivli provides to assist in this critical research. The one-day conference, co-hosted by PORTAL, the Harvard Medical School Center for Bioethics, and the Harvard Program in Therapeutic Science, reviewed promising initiatives such as the Vivli platform, and the roles these initiatives can play in driving forward the use of biomarkers in clinical research. Dr. Li introduced Vivli as an innovative platform for sharing and analyzing IPD, including biomarker data.

Vivli Data Analysis Challenge

Announcement and Call for Data Requests: Vivli Pioneers and Global Data Sharing Innovator Awards

Vivli is proud to launch the first of its data analysis challenges to support researchers to explore the studies that are available for searching and requesting on the Vivli platform. More than 3,100 studies are available for searching across numerous disease areas including hypertension, asthma, Crohn’s disease, dementia, and diabetes.

To encourage researchers to derive innovative analysis, drive forward scientific discoveries, and honor the contributions of trial participants, Vivli is launching two awards—the Vivli Pioneer and the Vivli Global Data Sharing Innovator Awards.

What:

The Vivli Pioneer Award will be conferred to the first approved 10 data requests that initiate analysis.  The lead investigators of these data requests will receive $1,000 awards.

The Vivli Global Data Sharing Innovator Award will be conferred to the first 10 data requests that complete and publish their analysis in a peer-reviewed journal. The lead investigator of the data request team (or designated team member) will receive a travel award to enable presenting these results at a future global Vivli Data Sharing meeting.

Winners of the Vivli Pioneer Award are also eligible for the Vivli Global Data Sharing Innovator Award.

Who:

The award is open to all researchers and researcher teams other than those directly employed by for-profit companies.

For questions please contact support@vivli.org. Please use subject line: Vivli Analysis Data Challenge.

How to submit entries:

To be considered for either award, you need to submit a data request on the Vivli platform.

When:

Don’t delay, the first ten data requests that meet either award requirements will be selected. So the sooner you submit a data request the more likely you are to receive the Vivli Pioneer Award. You can then conduct your analysis and, once your results are published in a peer-reviewed journal, be awarded the Vivli Global Data Sharing Innovator Award.

Data Requests should include:

Data Challenge Analysis Requests will follow the Vivli Data Request process. More information, including how to fill out a data request, is available in the Resources section of our site.

To be eligible for the Vivli Pioneer Award and/or the Vivli Global Data Sharing Innovator Award, applicants must request and be approved for more than one study for analysis.

To stay up to date on the latest news about the Vivli Data Analysis Challenge and other news related to data-sharing, please sign up today.