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Category: News

Boehringer Ingelheim joins Vivli as a new member

Boehringer Ingelheim will share patient level clinical study data with broad scientific community

“We are delighted to include Boehringer Ingelheim studies on the Vivli platform,” said Rebecca Li, Vivli Executive Director. “Leaders such as Boehringer Ingelheim are joining platforms such as Vivli to drive scientific discovery through data sharing to advance human health.”

Boehringer Ingelheim is a global, research-driven pharmaceutical company embracing many cultures and diverse societies. In joining Vivli, Boehringer Ingelheim demonstrates their strong commitment to clinical trial data sharing, to promote transparency and drive new discoveries. Boehringer Ingelheim supports Vivli’s mission, which is to promote, coordinate, and facilitate scientific sharing and reuse of clinical research data through the implementation of a sustainable global data-sharing enterprise.

“Pharmaceutical companies like us generate year by year a wealth of clinical drug development data which – after regulatory submission and evaluation – represent an invaluable asset for independent researchers to improve various public health aspects. Technology nowadays allows easy sharing of such huge data streams and Boehringer Ingelheim  would like to contribute to the expansion of this knowledge by providing our own data, which has been created by our more than 7000 employees in R+D worldwide and the health care personnel and patients we work with,” says Hans-Juergen Lomp, Head of Global Statistics.

For more information about how Boehringer Ingelheim shares data on Vivli, please visit their Member page. For additional information about Membership in Vivli, learn more here.

About Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company, therefore, concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company, therefore, aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Using Vivli to Meet ICMJE Data Sharing Requirements

 In June of 2017, the International Committee of Medical Journal Editors, or ICMJE, released new requirements for data sharing statements, for submissions to their publications. The ICMJE represents the most well-respected and influential publications in the biosciences, including the New England Journal of Medicine; the Lancet; Annals of Internal Medicine; the BMJ; and PLOS Medicine: These publications, and the many others which follow their lead, now require the inclusion of a data sharing statement in all submissions for publication. ICMJE publication editors may take these statements into consideration, when making editorial decisions. Researchers should also know that as of 1 January 2019, ICMJE requires inclusion of your data sharing statement at the time of trial registration.  

In their guidance to researchers, the ICMJE notes that when it comes to data sharing, “undecided is not an acceptable answer.”   When pre-registering interventional trials on clinicaltrials.gov, if “Undecided” is selected for the “Plan to Share IPD” data element, a note now appears indicating that the ICMJE data sharing policy requires a “Yes” or “No” answer to this question. The “Plan to Share IPD” data element is optional on CT.gov, but is required by the ICMJE as part of registration information for interventional studies  Rather than remaining “undecided,” see the chart below to learn how to use Vivli in completing your ICMJE data sharing statement: 

ICMJE Question  How to respond, if using Vivli to share your data:  
Will IPD (and data dictionaries) be made available? Yes
 What data in particular will be shared? Final cleaned individual participant-level data, de-identified*
What other documents will be made available? Final protocol, statistical analysis plan, and the data dictionary. (Note: additional documents such as CRFs and analytic code may also be included.) 
When will data be made available? X months /years after study completion
With whom?

Anyone with the relevant skillsets to conduct the analysis,  who submitted an approved proposal on Vivli.

Proposals are submitted on Vivli.
For what types of analysis?  To achieve the aims and objectives in the scientific proposal as approved via Vivli.
By what mechanism will data be made available? Following an approved request, a data use agreement must be signed.   Data are made available via a secure research environment or download.

 

For more information or assistance in using Vivli to meet data sharing requirements, email suppport@vivli.org.  

* Vivli partners with Privacy Analytics, to provide de-identification of data sets at a discounted rate for researchers who store and share their data on Vivli.  

Vivli Roundtable in Japan: One Year On: GDPR and Its Implications for Data Disclosure and Data Sharing  

Vivli will host roundtable discussions under the theme One Year On: GDPR and its Implications for Data Disclosure and Data Sharing. The meeting, scheduled for May 13, in Tokyo, Japan, will include discussion with experts in privacy and transparency of clinical trials.   

Speakers at the event include:  

 

Watch at your convenience the latest discussion in Vivli’s Webinar Series: Keys to Submitting a Quality Research Proposal to a Data Sharing Platform

Watch at your convenience the latest discussion in  Vivli’s Webinar Series: Keys to Submitting a Quality  Research Proposal to a Data Sharing Platform from March 20th.

Have you ever wanted to conduct secondary research on clinical trial data to answer a research question but didn’t know how? Vivli hosted a lively webinar discussion with experts from the data sharing community on how to submit a quality research  proposal with all the information needed for clinical trial sponsors and independent review panels (IRP) to make a decision  about your request.  This webinar is focused on helping researchers create the best research proposal possible, including navigating the review process.  

Watch Now 

 

Key topics covered:  

 -What resources are available to help formulate your research proposals? 

-What are the key elements that sponsors and IRPs look for in a request? 

-What are some commonly overlooked issues in research proposals? 

-What hints and tips would our panel provide to researchers when developing their proposal? 

-What are some key reasons for application revisions? 

-What is the key to formulating a strong and testable hypothesis? 

Panelists include:  

Cynthia Holas, AbbVie

Dr. Sonali Kochhar, Wellcome Trust IRP member   

Georgina Humphreys, Wellcome Trust secretariat  

Joe Ross and Ginger Gamble, the YODA Project  

Moderator: Rebecca Li, Executive Director, Vivli  

Vivli profiled in data sharing progress report

A new article highlighting the progress made in sharing clinical research data, including a mention of the Vivli platform, was published in BIO IT World today.

“Vivli also has promise in making datasets findable and available through a central platform,” wrote authors Frank Rockhold, Vivli Senior Advisor, and Asba Tasneen. Both are based at the Duke Clinical Research Institute.

Read more: Imperative for Open Data Access and Sharing

 

 

Dr Rebecca Li Commentary in STAT

A new commentary, published in STAT by Dr. Rebecca Li, Vivli Executive Director, argues that data sharing has moved from a conversation of whether or not data should be shared to one focusing on how to share data. She writes that this change has been taking place over a number of years and has been propelled forward by new requirements from leading journals that ask for a data sharing plan at the time a new trial is registered.

Move clinical trial data sharing from an option to an imperative. 

 

TrialScope and Vivli Partner to Address Rapidly Growing Transparency Needs of Clinical Trial Sponsors and Researchers

The strategic alliance enables Vivli and Trialscope to promote transparency and data sharing to advance scientific discoveries, reduce redundancies and improve patient care

TrialScope, the global leader in clinical trial transparency, compliance and patient engagement solutions, today announced a strategic partnership with Vivli, a nonprofit organization focused on sharing of clinical trial data through its innovative platform. The collaboration will offer sponsors and researchers access to the most complete solution for disclosure and data sharing.

TrialScope’s SaaS-based, centralized approach has met the disclosure and transparency needs of the trial industry from large pharmaceutical companies (13 of the top 15) to smaller biotech firms for more than five years. By working with Vivli, the company can offer its customers the most comprehensive approach to disclosure and data sharing in the market.

The alliance draws on complementary strengths of each partner and will deliver an opportunity for industry and academic sponsors to address all their disclosure and transparency needs, such as:

  • Disclosure and data-sharing software and advisory services
  • Technology to help people find help people find relevant, authoritative clinical trial information online
  • Plain-Language Summary authoring and hosting
  • End-to-end workflow support to manage data-sharing requests, including full data process preparation (collate, redact, anonymize, review, approve)
  • Access to an independent data-sharing review panel
  • The ability to host anonymized Individual Participant Data (IPD)
  • The ability for sponsors to share their data in a secure research environment.

“There is a growing trend towards increased transparency within the clinical trial industry, not just to meet regulatory requirements, but as an ethical obligation to advance science and promote patient safety,” said TrialScope CEO Jeff Kozloff. “We are honored to work with Vivli as a partner to provide our customers with a seamless and efficient platform for all of their data-sharing needs. We appreciate the fact that Vivli is disease agnostic and can synthesize data from multiple repositories, which will greatly reduce duplication of clinical trials, putting fewer patients through studies unnecessarily.”

Vivli, which launched in July 2018, is already receiving enthusiastic industry support and demand for its platform, which now hosts more than 3,200 trials conducted in 100 different countries from 16 members.

“We are delighted to partner with TrialScope, which is recognized as the leader in clinical trial disclosure,” said Rebecca Li, Ph.D., Executive Director of Vivli. “Together, we offer an end-to-end solution. There is simply no complete solution for researchers and sponsors alike, who want to spend less time searching for previous data, and more time on advancing science.”

Julie Wood, Vivli’s Director of Strategy and Operations, and Thomas Wicks, TrialScope’s Chief Strategy Officer, will be co-presenting at CBI’s 6th annual Clinical Data Disclosure and Transparency conference. They will explore the “Disclosure and Data Sharing Lifecycle” for attendees Jan. 30 at 9:30am ET in Philadelphia.

About TrialScope 

TrialScope is the global leader in clinical trial disclosure and transparency management technology, supporting 13 of the top 15 industry clinical trial sponsors worldwide. TrialScope provides proven solutions that optimize the efficiency of disclosure activities, maximize trial data transparency, and foster more informed, engaged patients through open research sharing. To learn more about TrialScope, visit TrialScope.com.

About Vivli

Vivli is a nonprofit organization managing a global data-sharing and analytics platform to serve all elements of the international research community. The organization acts as a neutral broker between data contributor and data user and the wider data-sharing community. The ultimate aim of Vivli is to advance human health from the insights and discoveries gained by sharing and analyzing clinical research data. For more information, visit vivli.org

Vivli Webinar: How to share and request data on Vivli 

Watch at your convenience the latest presentation in Vivli’s Webinar Series: How to share and request data on Vivli  

Vivli is pleased to provide an engaging presentation from Dr. Ida Sim, UCSF, on how to share and request data on Vivli.  Vivli co-founder and UCSF Professor of Medicine Dr. Ida Sim provides an overview of sharing and requesting data on Vivli. Dr. Sim will also demonstrate how researchers and others can use Vivli to meet data sharing requirements, including those from the NIH and leading journals.  

Watch now! 

Presenter bio: 

Dr. Ida Sim, MD, PhD