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What is IPD meta-analysis?

Meta-analysis is a statistical technique for combining sources of quantitative evidence. It is an example of secondary analysis, which is a subsequent analysis of clinical trial data. The original, or primary analysis of the data was for the purpose that the data was collected – with regards to the data presently shared on Vivli, a now-completed clinical trial.
Meta-analysis, like other forms of secondary analysis, looks back at data to answer a new question. Pairwise meta-analysis compares two sources of quantitative evidence “head-to-head.” For example, with clinical trial data a pairwise meta-analysis could compare directly the interventions in two different clinical studies; or it could compare an intervention and control arm.
Network meta-analysis evaluates more than two interventions against one another. Network meta-analysis can provide an estimate of the relative effectiveness of all interventions in the network – which can be helpful for improving health care decision-making.
Meta-analysis has traditionally been performed with aggregate data, including summary statistics (mean differences, event counts, odds ratios, hazard ratios etc.) extracted from published journal articles, conference abstracts, trial registries (e.g. clinicaltrials.gov), and unpublished documentation such as protocols, statistical analysis plans, and clinical study reports. However, the gold standard in meta-analysis involves the use of not aggregate but individual participant-level data or IPD. In IPD meta-analysis, the original participant level data is requested and re-analysed.
IPD meta-analysis allows a more flexible and complex analysis approach. The advantages are many, and include:

• Researcher can standardise or redefine outcomes
• Researcher can reinstate participants who may have been excluded
• Reduces publication, reporting and ecological biases
• Allows detailed checks of any analysis assumptions (e.g normality or proportional hazards).
• Allows for modelling heterogeneity (within and between studies)
• Consideration of covariates and treatment-covariate interactions
• Allows for modelling of prognostic and diagnostic data in synthesis

While the advantages are many, historically, IPD meta-analysis has been a difficult undertaking for even experienced researchers. However, new tools and platforms are changing the landscape of secondary analysis. If you would like to learn more about IPD meta-analysis, watch our webinar presentation on this topic. The learning objectives for our IPD meta-analysis webinar include:

• An introduction to individual patient data (IPD) meta-analysis
• Explanation of how platforms such as Vivli can facilitate IPD meta-analysis
• Exploration of the differences between IPD meta-analysis and aggregate data meta-analysis, including determining when IPD meta-analysis is the best approach to use.
• Review of examples of IPD meta-analysis.
• Discussion of practical aspects of retrieval of IPD from different sources.
• What to do when not all IPD is available for analysis.

If you have any questions about this blog or the Vivli platform, please email support@vivli.org.

Vivli 2018 Progress Report

We are delighted to share with you Vivli’s 2018 Progress Report. 

Vivli would not be here today if it was not for the aid, support and encouragement of all of you. We look forward to continuing to grow together in 2019 and beyond, as leaders in data sharing and transparency, working together towards our shared goals of improving human health.

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.