News & Events

Vivli Researcher Spotlight: Dr. Elena Myasoedova on accessing clinical trial data to advance research and the possibilities for using machine learning as a tool in clinical support for people with rheumatoid arthritis

Elena Myasoedova, M.D., Ph.D., is a clinical rheumatologist with specialty interest in inflammatory arthritis. She is an associate professor of medicine and epidemiology and clinical practice, and leads research in rheumatology and specifically inflammatory arthritis at the Mayo Clinic. Dr. Myasoedova’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Individualized Prediction of Treatment Response to Methotrexate in Patients with Rheumatoid Arthritis: A Machine Learning Approach”. Their completed research has been presented to the rheumatology research community at conferences and in publications including Annals of the Rheumatic Diseases. She sat down with Vivli to tell us more about accessing clinical trial data to advance her research, and the possibilities for using machine learning as a tool in clinical support for people with rheumatoid arthritis.

Please tell us a little bit more about your research – what led you to want to investigate this particular topic?
In patients with rheumatoid arthritis, methotrexate is a medicine that is used very commonly, and frequently is the first medicine and the most common medicine used in combination later on during the disease course. The challenge that we are facing in rheumatology in general is that we do not have individualized prediction of response to treatments. This means that we use a trial and error approach to treatments; we start patients on medications that are generally effective and safe, and then if a patient does not respond, we upgrade to a different medicine. Because most of the medicines that we use take weeks and months to show their effects, it’s important to understand early on if a person is likely to be a responder. That would help to save time and potentially save some unwanted side effects for the patient, and also help us to be more proactive and helpful.

For this specific study, we looked at clinical markers or clinical predictors of response to methotrexate. We found more than 1400 patients from 13 randomized trials. A total of 775 patients from 4 RCTs were included in the study, and we monitored their response across a six-month timeframe. We further evaluated whether people who did not respond to methotrexate and had some moderate to high disease activity at 12 weeks – who out of this population would respond by follow-up at 24 weeks. We also found a couple of markers for that: specifically if there was a drop in DAS28 sat rate from baseline to 12 weeks of at least 1 point, then it was predictive of then achieving remission or low disease activity at 24 weeks. Otherwise the chances were slim.

We developed this algorithm, and externally validated it using two independent trials with good results. I think that these findings advance the understanding of who are the most likely responders, and how we should discuss with patients their likelihood of response at the very start of their treatment.

Are you hoping that this is going to change the clinical approach? Has it already had an impact in clinical approaches to working with people who have arthritis?
This particular study, and similar studies would probably change the way we discuss this treatment with a patient; changing the treatment approach is a very complex task that probably has to come through the association guidelines.

Is there anything specific that you’d like to say about what working with the dataset in Vivli enabled you to do that you might not have been able to do otherwise?
It was actually a very good experience for us to work with Vivli datasets. It provided longitudinal data on patients who were users of methotrexate but not other medicines, and there were hundreds of these patients available from the trials. So it’s a fairly good dataset to work with, and it had multiple data points longitudinally. Also, at each point, there were multiple clinical points collected, so it was fairly comprehensive.

Do you have any advice that you would give to other researchers who might be interested in accessing this type of data using a platform like Vivli?
The most important advice is to put together a comprehensive proposal with a plan right off the bat, to make sure that the timeline is feasible and that the question that they want to address is feasible with the available data – just to make sure that they are not over-expecting or under-planning. I think it’s most important to ensure that the study question matches the data set.

Have you had feedback about your research and findings?
This research has been presented at several conferences, and the comments have mostly been positive, acknowledging the need for developing such algorithms.

T1D exercise data RFP from Helmsley Charitable Trust due the end of this month

The Leona M. and Harry B. Helmsley Charitable Trust’s Type 1 Diabetes Program has launched an initiative to support innovative and practicable solutions to help people with type 1 diabetes (T1D) exercise safely and to improve their quality of life. To help address knowledge gaps about the effect of exercise on T1D, Helmsley supported a research collaboration centered on two large observational exercise studies in people with T1D: one in adults (T1-DEXI) and one in children (T1-DEXIP). More than 500 people took part in the adult study, and another 250 in the pediatric study. Both studies were recruited and conducted fully remotely by design, enabling full monitoring and data collection which was unimpeded by COVID-19 pandemic restrictions.

The data from these studies include information about types of physical activity, heart rate, insulin use, CGM, diet, and genetics. The research collaboration collected and organized the observational data to maximize interoperability, and Helmsley has partnered with Vivli to make the data from T1-DEXI and T1-DEXIP publicly available. Sharing study data publicly will enable a range of researchers to access and explore the data from a variety of perspectives and research specialties.

In addition to facilitating public access through the Vivli platform, Helmsley has also opened a request for proposals (RFP) to support researchers, clinicians, and data scientists interested in analyzing the data and testing novel solutions in people with T1D. The RFP aims to fund projects that will improve the understanding of how exercise impacts T1D and that will provide people with T1D and their healthcare providers practical management solutions and clinical guidelines. The overarching purpose of this initiative is to move real-world data towards real-world solutions.

Concept notes for the RFP are due by April 30, 2023, and full proposals will be invited for submission later in 2023. Researchers interested in exploring the T1D dataset on Vivli in order to prepare concept notes for submission can search data publicly available through Vivli’s search portal, and submit a data request using the standard process. Complete information about the RFP, including key dates and submission criteria, is available on The Helmsley Charitable Trust site.

Deniz Dalton, Program Officer in T1D at Helmsley, said, “People with T1D face many burdensome challenges in their daily lives, including complex decisions around exercise, diet, monitoring glucose levels, and administering insulin. We are excited to make this data publicly available and to launch this RFP, to advance the understanding of how exercise affects glucose management, and ultimately to help create real-world solutions to challenges faced by people with T1D around exercise.”

For more information, please watch Dalton’s presentation on this initiative at the Vivli 2022 Annual Meeting, or contact Vivli User Support directly at support@vivli.org with any questions

Vivli Executive Director Dr. Rebecca Li Speaking at NIA-DUKE-Alzheimer’s Association Workshop

Rebecca Li will be speaking at the NIA-DUKE-Alzheimer’s Association Workshop held on March 15-16th sponsored by the National Institute on Aging.

The focus of the talk by Rebecca Li and Katherine Welsh-Bohmer (Duke University School of Medicine) is on how the Vivli platform can be used to access trials in Alzheimer’s Disease. Dr. Welsh-Bohmer will discuss the TOMMORROW trial – a large prevention study in Alzheimer’s Disease – as a specific use case.

Bayer Signs Up as a Member of Vivli

“We are thrilled to welcome Bayer as a member of Vivli,” said Rebecca Li, Vivli Executive Director. “We look forward to supporting researchers to request and analyze Bayer’s data securely.”

As a global leader in healthcare and nutrition, Bayer offers innovative products that support efforts to overcome challenges presented by a growing and aging global population by helping to prevent, alleviate and treat diseases.

“We are very excited to join Vivli and the large global community of leading clinical trial sponsors engaged in data sharing. Vivli offers a great opportunity for Bayer to further strengthen our commitments to transparency and data sharing for our clinical trials”, says Sigrid Achenbach, Head of Clinical Trial Transparency at Bayer.

For more information about the conditions for accessing Bayer anonymized data from completed clinical trials, please visit their member page. For additional information about Membership in Vivli, learn more here.

President Selects former Vivli External Advisory Committee member as National Cancer Institute Director

Vivli enthusiastically congratulates Dr. Monica Bertagnolli on her recent appointment as Director of the National Cancer Institute (NCI).

Dr. Bertagnolli has served as a long-time member on the Vivli External Advisory Committee.

“We are glad to see Dr. Monica Bertagnolli take on such an impactful role and we wish her all the best,” said Rebecca Li, Executive Director.

Biden Selects Harvard Professor as National Cancer Institute Director – The Harvard Crimson

Vivli Reaches Milestone: 100 Public Disclosures from Data Requested via Vivli

Vivli announced that it had reached a new milestone with 100 public disclosures, including many from peer-reviewed journal publications, has just been published using data requested via the Vivli platform.

We are so pleased that we have reached this milestone during the month of our four-year anniversary,” said Rebecca Li, Executive Director. “So much of the hard work belongs to our members and investigators who have made this possible. We are grateful for these continued support and use of the Vivli platform.”

For a list of all publications go to: https://vivli.org/public-disclosures/

NIH HEAL Initiative® joins Vivli as a member

Vivli welcomes our newest partner platform as a member, the NIH Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.

“We are delighted to include the NIH HEAL Initiative as a member of Vivli,” said Rebecca Li, Vivli Executive Director. “Making these valuable studies available for searching on Vivli is helping to ensure that researchers and the public can find and access them along with the other pain and addiction clinical research data on Vivli. Access of these data will drive scientific discovery, research dissemination and adoption to advance human health.”

Virtually every NIH Institute and Center is accelerating research through the NIH HEAL Initiative to address this public health emergency from all angles. A centerpiece effort to achieving HEAL’s mission is the HEAL Data Ecosystem, which aims to transform research data, findings, and publications into a virtual, annotated, searchable catalog where datasets can be analyzed, compared, and combined.

“HEAL-generated data holds the key to helping patients and communities devastated by the opioid crisis, as well as those seeking relief for unmanaged chronic pain that limits all aspects of life. Vivli offers a valuable tool for researchers in HEAL and beyond to access this rich set of data stored in various repositories that meet security and privacy standards – giving HEAL researchers a great option to leverage their data for new discovery and long-term preservation,” said Rebecca Baker, Ph.D., director of the initiative.

For more information about how the NIH HEAL Initiative supports its investigators to share their data on Vivli, please visit their member page. For additional information about Vivli membership, learn more.

Vivli is hiring a Executive Administrator

Vivli is a nonprofit organization working to advance human health through the insights and discoveries gained by sharing and analyzing clinical trial data. It is home to an independent global data-sharing and analytics platform which serves all elements of the international research community.

VIVLI, the Center for Global Clinical Research is seeking a seasoned Project Coordinator to assist with the launch of our global data sharing platform. The opportunity to join a fast-growing start-up environment with a mission-focused non-profit.

Individual must be a self-starter, experienced and able to work independently in a fast-paced start-up environment.

Team Coordination and responsibilities

  • Schedule calls and calendar management
  • Board coordination
  • Manage organization of legal agreements and contracts
  • Organize/solicit agendas and take notes for key meetings
  • Invoicing and billing
  • Submit expense claims, credit card reconciliation
  • Mail retrieval (periodically – approximately 2-3 times a month from Cambridge MRCT office)
  • Other administrative and support tasks, including supporting users of the Vivli platform and our members

Comms, Marketing

  • Send emails via Constant Contact and maintain email databases up-to-date
  • Update the WordPress website and social media including LinkedIn, Twitter, Facebook
  • Updating graphics and brochures, as required
  • Event management and support

Salary commensurate with experience.

To apply email hr@vivli.org

 

Vivli is hiring a Program Manager

VIVLI, the Center for Global Clinical Research is seeking a seasoned Program Manager. Vivli is a mission-focused non-profit. For more information see www.vivliorg.kinsta.cloud

Program Manager (Job Description)
Overall Duties and Responsibilities include the following:

Vivli’s Program Manager has responsibility for:

  • The program manager would oversee and manage a portfolio of grants and contracted projects to ensure effective and timely administration of milestones and goals.
  • The program manager will support the coordination and processing of agreements (data contributor agreements, data user agreements, MOUs).
  • Assist with proposal processing as needed on the Vivli platform.
  • Vivli platform QA.
  • Support end-users as necessary.
  • Support the Vivli resource library as necessary.

Ideal Qualifications

  • Experience developing and managing a project plan
  • Experience managing timelines and budgets
  • Understanding of clinical trials and/or clinical data management preferred
  • Excellent written and oral communication skills
  • Computer proficiency in MS Office, Excel, PowerPoint, Sharepoint, Dropbox etc.
  • Excellent organizational skills and attention to detail
  • Ability to manage projects and resources
  • Bachelor’s degree in health profession, science, IT or business field
  • Prior demonstrated experience in Data Sharing or Data Transparency field

To apply, send a cover letter and CV to hr@vivli.org.

Vivli Executive Director to take part in panel at Duke-FDA event on rare diseases and data sharing

Vivli Executive Director, Rebecca Li, will take part in a panel discussion as part of Data Sharing to Accelerate Therapeutic Development for Rare Diseases hosted by Duke and the FDA. Her session will focus on platform analytics tools to support data sharing and drug development for rare diseases.

The Duke-Margolis Center for Health Policy, through a cooperative agreement with the U.S. Food & Drug Administration, is convening a two-day public meeting on August 18th and 19th, to discuss the importance of data sharing for accelerated therapeutic development in rare disease as well as considerations for sustaining and leveraging a robust data sharing infrastructure to support innovative rare disease trial design. The meeting will explore several topics including:

  • The importance of shared data to support innovation and quality in the drug development pipeline for rare diseases
  • Approaches and challenges to ensuring data quality, standardization, and interoperability in shared data resources
  • The role of regulatory agencies in strengthening rare disease data collection and shared data resources

Please see the event page for more details and to register for the event.