Vivli board member Mark Barnes, JD, LLM will speak on a panel entitled “Sharing Individual Participant Data (IPD) from Clinical Trials and Personal Information Protection” on November 11 at the 16th DIA Japan Annual Meeting 2019 in Tokyo. Find out more.
Vivli is always looking to improve its data sharing platform and the support it provides to its users.
We are asking all platform users to help us by taking our brief survey today.
We will use the results of the survey to continue to develop our platform and user support.
Thank you in advance for your feedback.
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Lilly will share patient-level clinical study data
“We are thrilled to welcome Lilly as a member of Vivli and to be able to list their studies on the platform,” said Rebecca Li, Vivli Executive Director.
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world.
“Lilly is delighted to be joining Vivli and to work in partnership with them to share our data through this environment,” said Ben Rotz, Senior Advisor-Global Medical Strategy, Policy, and Operations from Lilly. “We look forward to working with the Vivli team as well as the other members to continue to advance and move forward data sharing.”
For more information about how Lilly shares data on Vivli, please visit their member page. For additional information about Membership in Vivli, learn more here.
Vivli has been awarded Soc 2, Type 2 compliance by an independent auditor. Service Organization Control 2, or SOC 2 compliance is a component of the American Institute of CPAs 
(AICPA)’sService Organization Control reporting platform. SOC 2 reports on controls that directly relate to security, availability, processing integrity, confidentiality, and privacy of data.
In addition, the Vivli platform is built entirely as an application within the Microsoft Azure Cloud, thus taking advantage of the numerous security features developed by Microsoft’s state-of-the art system and processes.
More than 60 participants forming 11 teams, took part in the first Vivli Microsoft Data Challenge today at District Hall in Boston. Participants were from universities including Harvard, Northeastern, Brown, and Boston as well as nearby hospitals, pharmaceutical, biotech and software companies.
The data challenge focused on finding innovative solutions for how to safeguard participant privacy and minimize privacy loss while maintaining the scientific analytic value of the data for rare disease data sets that are more highly identifiable.
The day started off with a presentation by patient advocate Jane Perlmutter sharing with the attendees the importance of this challenge.
“I’m a long-term cancer survivor… patients don’t have the luxury of patience, she said. “When they enter a clinical trial, they’re hoping they would profit form it, hoping future generations won’t have to suffer from it as well.”
The teams had one hour to plan and then four hours to come up with their solutions. They were then given five minutes to present their ideas to the judges.
“The Datathon has met our expectations, there’s a really diverse group of people that are rallying around solving a problem,” Paul Slater, co-founder of the Clinical Research Innovation Hub at Microsoft. “They’re discovering, there’s a bunch of innovative approaches to this, we don’t know if we’re getting an end solution but we may certainly get ourselves closer to it. This might be an opportunity to blend some of the best ideas together to make some meaningful products. The thing we’re going after is high impact.”
The winners are:
Global Grand Prize Winner:
Team: DBMI
Participants: Gaurav Luthria and Qingbo Wang, Harvard University
Most Innovative Solution:
Team: DataHack
Participants: Cynthia Frommit (IND), Het Patel (Beth Israel), Vikas Gaikwad (Plural Point), Luther Evans (MGH Martinos Center), Annadoir Stavely (Otsuka USA) and Vikramen Karunanidhi (Ayu Devices)
Most Outstanding Graduate Submission:
Team: SAIL
Participants: Megan Fantes, Kinan Dak Albab, Wyatt Howe, Yi Zhang, Peter Flockhart, Lucy Qin from Boston University
Outstanding Remote Submission:
Team: Next Tech Lab
Participants: Sourva Sharan, Arjun Bahuguna from Next Tech Lab
Find out more about the Datathon and see the full list of Datathon submissions.
Vivli’s Executive Director Rebecca Li will speak at the 6th World Conference in Research Integrity in Hong Kong in June. Li will take part in a symposium on data sharing as it relates to research transparency.
By Rebecca Li, Vivli Executive Director
I started my career at a small biotech company and understand the intensity of the start-up experience as well as the experience of the more mature mid-size biotech and pharma company. Data sharing can be an after-thought to the challenges of bringing treatments to the clinic. We at Vivli often receive inquiries along the lines of: “When should we start implementing a ‘real’ data sharing program?” The inquiries run the gamut from companies just beginning their data sharing journey to those that have done this proficiently. We know many who have started to outgrow homegrown sharing systems and processes that functioned well initially, and now the rate of incoming enquiries may be more than those systems can handle. Companies beginning the data sharing journey may be clinically early stage or have a marketed drug.
What’s it take to get serious about data sharing? Some questions and answers may help.
Why should we share?
There are numerous ethical reasons to share clinical trial data responsibly. Various industry organizations have set public commitments for their members as principles. For example, BIO a trade association that represents thousands of small and mid-size biotechnology members, committed in 2014 to make transparent and facilitate the process for qualified data requests of individual participant level data for approved medicines [1]. Likewise PhRMA/EFPIA[2] and IFPMA[3], influential trade organizations in the US and internationally for the industry, have committed to data sharing for the pharmaceutical industry
When should we begin the program?
If a company has one or more programs in late-stage clinical development, then 18 months prior to either marketing authorization or regulatory decision is a realistic timeframe to seriously considering putting a data sharing program in place. Like most things in life, starting the planning earlier allows for a high-quality program to be implemented with greater degrees of freedom. Therefore, if you anticipate that there will be trial data to share within the next 18 months or less it is important to start the planning process for a data sharing program now.
How do we start to build a data sharing program?
A data sharing program consists of three primary components – a Policy, a Mechanism and the Resources to manage and oversee the program – we describe these components in brief below. A Policy for data sharing typically includes a written public statement for governance (covering areas such as which trials are available for sharing, when those data are available, who is qualified to make a request and how, and whether there are exceptions to these policies). Additionally, a Data Use Agreement – the legally binding agreement which governs data access to outside researchers – should be developed to protect all parties involved including the research participants. A Mechanism for data sharing should be described – this is the IT infrastructure, portal or platform management system that has been developed to manage the data sharing program. Lastly, sufficient Resources (human and capital) should be tapped to oversee and implement the program and scalable to meet demand once Policy and Mechanism are set in place.
How can we manage a data sharing program?
On your own internally or through a trusted external partner. Similar to other partnering decisions such as the tactical use of a CRO, externally managed mechanisms for data sharing exist. If there are available resources internally that are capable of initiating this effort – they should also be available to oversee and sustain this effort over time. Internal efforts, may be typically comprised of a multi-functional team drawn from biostatistics, clinical data disclosure, biometrics and at times members from other functions such as medical writing, program management, legal, IT, and clinical operations are called upon for their expertise.
What can partners like Vivli do for us?
VIVLI was established several years ago and offers our members a comprehensive data sharing program including Policies, a Mechanism for data sharing and Resources. This includes assistance with setting up policies and access to harmonized legal agreements that are already vetted with a broad range of stakeholders. Additionally, the Vivli team can advise your leadership if necessary on public-facing data sharing policies for public or private organizations and will discuss a solution tailored to your current situation. The Vivli platform is user-friendly and flexible, and provides a team – an extension of yours – to ensure seamless data sharing.
If you are interested in learning more you can watch the webinar.
[1] https://www.bio.org/articles/bio-principles-clinical-trial-data-sharing
[2] https://www.phrma.org/press-release/joint-efpia-phrma-principles-for-responsible-clinical-trial-data-sharing-become-effective-today
[3] https://www.ifpma.org/wp-content/uploads/2010/11/IFPMA-Principles_Data-Sharing-FINAL-w-QA-vF.pdf
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.
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 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: