Vivli Executive Director Rebecca to will speak at the Office of Human Research Protection (OHRP) 2019 Exploratory Workshop Privacy & Health Research in a Data-Driven World on September 19. The Bethesda, Maryland, event runs from 8.15am-4.15pm EDT and will have a live webcast. The workshop agenda includes three separate sessions related to the theme of privacy and health research in a data-driven world and videos of each session will be available after the event. Dr. Li will speak on The Vivli Experience in Sharing Clinical Trial Data Globally.
Category: News
Patients Don’t Have the Luxury of Patience
Long-term cancer survivor and patient advocate Jane Perlmutter tells us why data sharing is so important for people with rare diseases.
Q: Why should we share data from clinical trials?
Jane Perlmutter: I spent half my life as a cancer survivor. At first, I thought I wouldn’t survive it–and I’ve had three more cancer diagnoses since. I’m still here. And I’m here because people have contributed their own experience by being in clinical trials.But we need to learn faster. I like to say patients don’t have the luxury of patience. By allowing researchers to get access to data from multiple clinical trials, we can get to better solutions more rapidly and help more patients.
Q: What does data sharing mean for people with rare disease?
JP: When patients are diagnosed with a disease, especially a rare disease, it’s often very traumatic, and they want to find some way to get meaning out of that traumatic experience. One way is to participate in a clinical trial. They hope that their experience helps answer some questions and lead to some solutions so that their children or future generations won’t have to suffer the same things as they did. Sharing data from these trials increases the chances that their experience will be meaningful. There are fewer trials for very rare diseases, and that’s one reason why it’s even more important that we share those data and make the most of them.
Q: Aren’t you concerned about privacy with data sharing?
JP: To make people feel secure in sharing their data, we need to ensure there is some privacy so that their personal information doesn’t get out. When it comes to rare diseases, there are fewer of those patients, so protecting their data becomes even more of a challenge. The good news is, there are many ways to protect patients’ identities. And, while privacy is important, what’s most important for the patients–and they will tell you this–is that many researchers can use the data. A recent study showed that 93% of patients who are in clinical trials are happy to have their data shared with more and more researchers.
Q: How can platforms like Vivli help?
P: It can be difficult for a researcher that runs a clinical trial to figure out how to share data, but Vivli makes it easy. To learn as rapidly as possible, and get to better treatments and cures faster, researchers need as much data as they can get their hands on. That’s what Vivli is all about.
Vivli board member to speak at DIA Japan
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.
Take part in the Vivli User Survey today
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 signs up as a member of Vivli, the global data sharing platform
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 Attains Soc 2, Type 2 Compliance
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.
Winners announced for Vivli Microsoft Data Challenge
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.
Rebecca Li to present at the 6th Annual WRCI Conference in Hong Kong
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.
Top five questions small and mid-size companies should ask before embarking on a data sharing program
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.
If you are interested in learning more you can watch the webinar.
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 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.