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Category: Blog

Vivli Researcher Spotlight: Making an Impact in Oncology Treatment Using Individual Patient-Level Data

Analyzing individual patient-level data (IPD) from completed clinical trials to glean additional insights about patient populations is a key benefit of data sharing and reuse. Dr. Ashley Hopkins and his research colleagues have identified clinical trial data as an important source of information, particularly on emerging treatments which may not yet have a large pool of real world data. They have successfully leveraged data from the Vivli platform across multiple health areas, with a particular focus in oncology, including across lung, breast, and neural cancers.

In a recent conversation with Vivli, Dr. Hopkins talked about his research projects, including a recent example involving a significant finding related to potential associations between proton pump inhibitor use and outcomes with the monoclonal antibody atezolizumab. When used in combination with bevacizumab (another monoclonal antibody), and chemotherapy medications such as carboplatin and paclitaxel, the research team identified associations which could alter survival outcomes.

Dr. Hopkins and his colleagues have also used IPD available on the Vivli platform to inform a number of other questions, which have produced multiple publications over the last several years.

“I come from a perspective of being a pharmacist, which has led me on a journey and transition across the research,” said Dr. Hopkins. “I still want to be able to provide patients with the best possible information about the medicines.”

Read more about Dr. Hopkins’ research:

Efficacy of Atezolizumab in Patients With Advanced NSCLC Receiving Concomitant Antibiotic or Proton Pump Inhibitor Treatment: Pooled Analysis of Five Randomized Control Trials (Journal of Thoracic Oncology)

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.

Vivli Webinar: The Potential Impact of Recent U.S. Legal Developments on Data Sharing with China and Other Countries of Concern

Vivli held a webinar to discuss recent developments in data privacy laws and their impact on data sharing.

This webinar was held at 5pm CEST / 11am EDT / 8am PDT on Friday, April 12th

VIEW THE RECORDING

Over the past few weeks there have been significant U.S. executive and congressional actions related to restricting transactions, data transfers, and certain types of contracts with China, other countries of concern (e.g., Russia), and individuals and businesses connected with these countries. Principally, this includes President Biden’s Executive Order (“EO”) on bulk sensitive personal data transfers and the corresponding U.S. Department of Justice Advance Notice of Proposed Rulemaking (“ANPRM”), the unanimous passage by the U.S. House of Representatives of the Protecting Americans’ Data from Foreign Adversaries Act, and the passage of the BIOSECURE Act by a critical Senate Committee.

All three of these developments, if finalized, will have important impacts on the sharing of data and biospecimens with China and certain other jurisdictions that have been labeled “countries of concern.” In this presentation, Ropes & Gray partner, David Peloquin, will walk through these different proposed regulations and legislation, focusing on the implications they each may have for research data sharing. He will also discuss the different timelines and comment periods for the EO and ANPRM, as well as the current status of each of the pending pieces of legislation.

Speaker:

  • David Peloquin, Partner, Ropes & Gray

Learning objectives for this session include:

  • Understanding the basics of the EO, the ANPRM, the BIOSECURE Act and the Protecting Americans’ Data from Foreign Adversaries Act
  • Understanding how each of these proposed regulations or pieces of legislation may affect research data sharing with China and other countries of concern
  • Understanding the potential timelines for implementation of each of these proposed regulations and pieces of legislation

VIEW THE RECORDING

Vivli Researcher Spotlight: Reusing Data from a Completed Clinical Trial to Inform Guidelines

In a recent study led by Dr. Sarah Nevitt, a senior research associate at the University of Liverpool, a team of researchers examined the effectiveness of various antiepileptic drugs (AEDs) used as monotherapy for people experiencing seizures due to epilepsy. Epilepsy, a common neurological disorder, results from abnormal electrical discharges in the brain, causing recurrent seizures. Typically, around 60% to 70% of individuals with epilepsy achieve longer-term remission, often shortly after beginning treatment with antiepileptic drugs.

Dr. Nevitt and her team sought to compare the performance of 12 different AEDs in terms of treatment failure, remission, and occurrence of first seizures among both children and adults with focal onset or generalized tonic‐clonic seizures. They analyzed data from an extensive collection of clinical trials encompassing more than 22,000 participants, incorporating individual patient data from various studies using a network meta-analysis.

The analysis revealed some key insights. Older drugs like phenobarbitone and phenytoin demonstrated better seizure control for both focal and generalized seizures but had poorer long-term retention rates compared to newer medications such as lamotrigine and levetiracetam. Sodium valproate emerged as the top choice for achieving control and remission of generalized tonic‐clonic seizures, although it might not be suitable for everyone, especially people of childbearing age, due to associated risks.

These findings, published in the Cochrane Library, have already influenced the update of UK guidelines in 2022, providing immediate impact on the treatment of individuals newly diagnosed with epilepsy in the UK. In a recent conversation with Vivli, Dr. Nevitt highlighted that these results are guiding the approach to epilepsy treatment, emphasizing the importance of considering both efficacy and potential side effects when selecting appropriate medications for individuals experiencing seizures.

Interested in finding out more about how access to Vivli’s data repository can help advance your research? Find out more about how to search and request data.



Vivli Researcher Spotlight: Assessing Clinical Trial Data on Cardiac Risk in Type 2 Diabetes Treatment

Dr. João Sérgio Neves is an endocrinologist, based in the Faculty of Medicine of the University of Porto and São João Hospital in Porto, Portugal. Dr. Neves’s team submitted a research proposal to access Vivli to conduct analysis relevant to their topic, “Albiglutide and Cardiovascular Outcomes in Type 2 Diabetes With and Without Concomitant Sodium-Glucose Cotransporter-2 Inhibition Use”. The team’s completed research has been presented in publications including the Journal of the American College of Cardiology. Dr. Neves sat down with Vivli to tell us more about accessing individual participant data to advance his research, and the potential for combination therapy to reduce the risk of cardiovascular events in patients with Type 2 Diabetes.

Could you tell us a little bit about your research? What got you interested in the particular area of research that you carried out working with Vivli?

So I am a clinical endocrinologist; I do clinical research in the field of Endocrinology. I have a particular interest in the effects of endocrine diseases on cardiovascular risk and on cardiac function. My main areas of research have been obesity, diabetes, and pre-diabetes. Previous studies conducted by our team have explored the effects of GLP-1 receptor agonists in patients with diabetes, both with and without heart failure. One of the questions that was still unanswered from the literature was whether the benefits of GLP-1 receptor agonists were still observed in those that were already treated with SGLT2 inhibitors. These two classes of drugs are known to be protective from a cardiovascular perspective for patients with Type 2 Diabetes. However, the two classes were developed and the clinical trials were conducted in parallel. So when clinical trials of GLP-1 receptor agonists (AMPLITUDE-O trial and Harmony Outcomes study) were conducted a bit later and included participants that were already treated with SGLT2 inhibitors at baseline. The authors of the AMPLITUDE-O trial had already performed a sub-analysis evaluating the effects of the GLP-1 receptor agonists in patients treated with SGLT2 inhibitors. Given the relevance of further exploring the combination of GLP-1 receptor agonists with SGLT2 inhibitors, our group requested the Harmony Outcomes study from Vivli. The we also performed a meta-analysis combining the results of the Harmony Outcomes study with the results from the AMPLITUDE-O trial. So there are two trials that we included that evaluate the effects of GLP-1 receptor agonists and included some patients using SGLT2 inhibitors and we wanted to know if this data could help us understand if both drugs when combined can give further cardiovascular protection to patients with Type 2 Diabetes.

And having come to the conclusions that you did – that there may be further reduction in cardiovascular risk but that more clinical trials with combination therapy are required – have the findings from this made any impact in terms of research practice that you’re aware of, since the findings have become available?

So since the findings became available, there has been some interest from other doctors contacting us on how to interpret our findings. We are very cautious and we believe that further data and dedicated clinical trials are necessary to thoroughly evaluate this drug combination. However, acknowledging that these trials might take several years to be conducted, we also recognize that our existing data could assist physicians in making informed decisions about utilizing this combination in the interim. We believe that  the results of the Harmony Outcomes trial, in combination with the AMPLITUDE-O trial, favor the possibility that the combination of both drugs is protective from a cardiovascular perspective.

Interestingly, in the same month our paper was published in the Journal of the American College of Cardiology, the European Society of Cardiology published an updated guideline on the treatment of patients with Type 2 Diabetes and cardiovascular disease, and they recommended that patients with Type 2 Diabetes and cardiovascular disease should be treated with both drugs. They did not yet cite our paper because it was published just before publication of the guideline, but they do cite, for example, the AMPLITUDE-O trial. So I believe that our data will reinforce this recommendation; and we see that the field of treatment and prevention of cardiovascular disease in Type 2 Diabetes was already moving in the direction of our findings. But as there was only one study evaluating this combination, we think that our results will be very important for supporting the use of GLP-1 receptor agonists in combination with SGLT2 inhibitors.

Can you talk a little bit about using the data that was available through Vivli; what were you able to do using that data that you were not able to do otherwise?

The type of analysis we aimed to conduct could theoretically be performed using observational data. However, utilizing observational data poses significant challenges due to numerous confounders, particularly when assessing the effects of therapeutic interventions involving drugs. This limitation is well-documented, and such an approach would lack robustness, potentially raising more questions than providing answers. I think that the most interesting thing about the analysis that we performed was that this was a clinical trial that was already performed; the data was already available.

When we analyzed the data we worked with the authors from the primary paper; we got in contact with the authors of the primary analysis and we planned this analysis together. Our interactions with the original authors were invaluable in interpreting the data, given their familiarity with it. This collaborative effort resulted in an interesting analysis and yielded important results.

Can you talk a little bit about your experience of working with the Vivli platform – the processes and technology and what that was like?

I think that the process was quite easy, the instructions are clear. We know that there is always some type of bureaucracy that is involved, but that’s part of how it works, because we are dealing with data from patients. Of course it is anonymized data but I think that’s not different from what I was used to with other types of shared data. , The process works quite smoothly.

The thing that I feel that was a little bit different from our previous experience with secondary analyses, was the use of a platform for analyzing the data outside of our computers. Nevertheless, we successfully conducted our data analysis, and the data was also accessible within the remote computer, allowing us to execute the entire analysis seamlessly.

And how did you find out about Vivli and the opportunity to reuse shared data in general?

We had previously conducted analyses through the secondary analysis of existing data, utilizing platforms such as BioLINCC , which incorporates data from studies sponsored by NIH. Our awareness of Vivli stemmed from mentions in papers that disclosed their data sharing approaches, indicating that access could be facilitated through Vivli. This was my first personal experience using Vivli, and I must say that I find the work undertaken by the Vivli team truly remarkable. Your efforts contribute significantly to the future of research and the enhanced utilization of already collected data.

How has the direction of your own research been affected by the research that you did on this project? Has it affected what you’re doing or changed your direction in any way?

I believe it has provided clarity on the next steps to enhance knowledge in this field. In our team, we recognized that addressing whether the treatments were additive or not would be a pivotal question. If we discovered that the combination did not yield additional risk reduction, we needed to understand which drug to select for specific patients. With the results we obtained, our focus shifted towards understanding how to improve access to these drugs and assessing their effectiveness in other populations, particularly in the earlier phases of Type 2 Diabetes and even pre-diabetes. As we design new clinical trials, we are already incorporating the insights gained from this analysis.

Would you use the Vivli platform again? Are there any changes or improvements that you would recommend to how it works?

Certainly, the experience was highly positive, and I look forward to working again with Vivli in the future. One overarching improvement (that’s not specific to Vivli) would be to expand access to even more data. I do believe that the data is very valuable and that it is very important to share the data from large clinical trials. The type of study that we analyzed is probably the most relevant that should be shared – of course with a very specific and detailed analysis plan and with all the regulations that are needed in this context. Considering the substantial resources and time invested in these clinical trials, there is often a wealth of data that remains untapped. Many crucial analyses may not have been conducted and researchers not primarily involved in the clinical trial may be able to identify these questions and answer them using the data from that trial. Therefore, it is important to facilitate access to this valuable resource.

So my main recommendation is to try to increase even further the number of studies that are available. Of course this also depends on the companies that own the data and the drugs that are being evaluated. But our analysis could not be performed without the sharing by GSK, so we are also thankful for their contribution to Vivli and for the sharing of the data.

And is there any advice you would give to other researchers who are at the beginning of the process of requesting or using shared data?

My main advice is to have a very specific question that the researchers want to answer; develop a detailed analysis plan; and submit the request to the Vivli platform. While the process may take some time, it is not overly complex. With patience and adherence to the required steps, one can successfully obtain access to the data. I firmly believe that enhancing the utilization of the Vivli platform and increasing access to data from large clinical trials will significantly improve the quality of knowledge across various fields in medicine.

Event: Shaping the next 10 years in data sharing: Building on the gains made and looking ahead to the next 10 years in advancing human health

Please join Vivli at the National Academy of Medicine in Washington, DC on November 16, 2023 in Washington, D.C. for a strategic meeting to collectively reflect on the seminal 2015 IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk to see how far we have come and chart a course to meet the challenges and opportunities that lie ahead.

PROCEEDINGS RECORDINGS

Session topics will focus on the following areas:

  • Welcome by Victor J Dzau, NAM President
  • IOM Report – 2015 Recommendations and Challenges Ahead
  • The value of data sharing realized –Use Cases
  • Credit and incentivizing the academic culture
  • Key technologies that will influence data sharing (machine learning, AI)
  • Regulations and policies to promote data sharing and re-use
  • Shaping inputs and directions for the next 10 years

We look forward to welcoming researchers, data contributors, publishers, funders and other interested stakeholders to this event as we work together to set a direction for data sharing and develop an action plan for the next 10 years.

This event is free, but registration is mandatory. Please register as soon as possible, as in-person space is limited. Virtual attendees will be able to view and ask questions of presenters. For virtual attendees, participation in the breakout groups and direction setting sessions will be limited. Please email support@vivli.org with any questions.

Agenda

 

Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the National Institutes of Health (NIH), will join as the lunchtime keynote speaker on Thursday, November 16th. Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person.

Dr. Bertagnolli is the second woman to lead the NIH on a permanent basis. Previously, Bertagnolli served as Director of the National Cancer Institute and has served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.

The 2015 IOM Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk Recommendations and Challenges ahead
Should we collectively set a new “north star” for the next 10 years?

Moderator: Bernard Lo, M.D., Professor of Medicine Emeritus, University of California San Francisco

  • Jeffrey M. Drazen, M.D. NEJM Group Editor, The New England Journal of Medicine
  • Professor Arti K. Rai, Elvin R. Latty Professor of Law, Duke Law
  • Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder
  • Joanne Waldstreicher, M.D., Independent Director, Becton Dickinson and Structure Therapeutics; Former Chief Medical Officer, Johnson & Johnson (retired); Faculty Affiliate, Division of Medical Ethics, New York University School of Medicine

The Value of Data Sharing Realized
This session will focus on real-life case studies that show the fruition of efforts to share data and its impact on science.

Moderator: Murray Stewart, M.D., Chief Medical Officer, Rhythm Pharmaceuticals, Inc., Vivli Board member

  • Ricardo Jorge de Oliveira Ferreira, Ph.D., Auxiliary Researcher at the Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL)
  • Richard Liwski, Chief Technology Officer and Director, Critical Path Institute’s Data Collaboration Center
  • Rebecca Li, Ph.D., CEO and co-founder, Vivli
  • Sarah Nevitt, Ph.D., Senior Research Fellow, Centre for Reviews and Dissemination, University of York
  • Ronald Summers, M.D., Ph.D., Senior Investigator, Imaging Biomarkers and Computer-Aided Diagnosis Laboratory, NIH Clinical Center

 

Credit and Incentivizing the Academic Culture
With the recent policy announcements by the White House and the newly updated NIH Data Management and Sharing Policy, movements are afoot to prompt academic researchers to share. What more can be done to encourage academic researchers to share their data by leveraging incentives?

Moderator: Barbara Bierer, M.D., Faculty Director, MRCT Center, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Director Regulatory Foundations, Ethics and Law, Harvard CTSA; Vivli co-founder

  • Elliott Antman, M.D., Director, Harvard Postgraduate Program in Clinical/Translational Science, Professor of Medicine, Harvard Medical School
  • Daniel Ernest Ford, M.D., M.P.H., Director & Professor of Medicine, Senior Associate Dean for Clinical and Translational Research, Johns Hopkins Institute for Clinical and Translational Research
  • Benjamin Pierson, Deputy Director, Enterprise Data, Bill & Melinda Gates Foundation

 

Key Technologies that will Influence Data Sharing (Machine learning, AI)
What role with key technologies such as Generative AI and other key technological advances play in data sharing? What are the key motivating factors and obstacles that will need to be addressed?

Moderator: Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder

  • Joshua C. Mandel, M.D., Chief Architect for Healthcare, Microsoft; Lecturer on Biomedical Informatics, Harvard Medical School
  • Philip Payne, Ph.D., FACMI, FAMIA, FAIMBE, FIAHSI, Director, Institute for Informatics, Data Science and Biostatistics (I2DB); Chief Data Scientist and Associate Dean of Health Information & Data Science; Washington University School of Medicine in St. Louis
  • Jane Perlmutter, M.B.A., Ph.D., President and Founder, Gemini Group Consultancy

Regulations and Policies to Promote Data Sharing and Re-Use
Given recent shifts in national policies to promote data re-use as well as efforts by publishers to promote data reuse, what more can be done by regulators, national governments, publishers and other key actors to advance data sharing and subsequent re-use?

Moderator: Michael Stebbins, Ph.D., President Science Advisors. Vivli Board Chair

  • Steven Kern, Ph.D., Executive Director, Global Health Labs
  • Michael Lauer, M.D., Deputy Director for Extramural Research, NIH Office of the Director
  • Deven McGraw, J.D., M.P.H, LLM, Lead, Data Stewardship and Data Sharing, Invitae
  • Sharon Terry, M.A., Chief Executive Officer, Genetic Alliance

PROCEEDINGS RECORDINGS

Keynote speakers: Monica Bertagnolli, the NCI Director, and Robert Califf, FDA Commissioner, to present at the Vivli meeting at the National Academy of Sciences in November.

Vivli is delighted to announce the addition of two keynote speakers to the agenda for our upcoming event, “Shaping the next 10 years in Data Sharing.” Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the US National Cancer Institute (NCI), will join as the lunchtime keynote speaker on Thursday, November 16th.

“Dr. Bertagnolli and Dr. Califf have extensively advocated for data sharing and we eagerly anticipate their insights next month on this important topic,” said CEO Rebecca Li. “We are thrilled they will be joining us.”

Bertagnolli and Califf will join a range of distinguished presenters and participants including researchers, data contributors, publishers, patient advocates, funders, and other interested stakeholders gathering to reflect on the gains made in the past 10 years of data sharing and set new goals and plans for the future.

Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person. To be part of this conversation please make a plan to join us in Washington, DC on November 16. Registration is free, but spaces are limited!

Dr. Bertagnolli joined the National Cancer Institute as its director in 2022. Prior to that she served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.

PROCEEDINGS RECORDINGS

Awardees Announced for the Vivli AMR Surveillance Open Data Re-Use Data Challenge, funded by Wellcome

Awardees Announced for the Vivli AMR Surveillance Open Data Re-Use Data Challenge, funded by Wellcome

Vivli is pleased to announce the awardees of the Vivli Antimicrobial Resistance (AMR) Surveillance Open Data Re-Use Data Challenge. This initiative comes at a crucial juncture, with the World Health Organization (WHO) identifying Antimicrobial Resistance as one of the top 10 global health threats facing humanity. Alarmingly, antimicrobial-resistant infections have the potential to become the leading cause of death worldwide by 2050. In response to this pressing issue, Vivli and Wellcome joined forces in mid-2022 to launch the AMR Register, a novel platform featuring industry datasets, consolidating surveillance data for the benefit of researchers.

The AMR Data Challenge, funded by Wellcome, was launched in April 2023, as a catalyst for innovation and support for the inventive reutilization of the wealth of surveillance data available within the AMR Register.

“The AMR data challenge not only reflects the extensive interest but also underscores the significance of making AMR data readily accessible to investigators. Data serves as a catalyst for innovative approaches, which are essential in addressing the global AMR challenge,” said Arjun Srinivasan, MD. CAPT, USPS, Deputy Director for Program Improvement Division of Healthcare Quality Promotion, CDC.

A total of 56 teams from 28 different countries participated in the AMR Data Challenge. This event served as a unique platform for multidisciplinary teams to leverage high-quality industry AMR surveillance data, proposing groundbreaking advancements and tools for use in AMR surveillance. The Challenge culminated in the recognition of six outstanding winners for the AMR Surveillance Open Data Re-Use Data Challenge.

The Grand Prize was awarded to Dr. Fredrick Mutisya, Health Data Scientist & Medical Doctor of Narok County, Kenya, and Dr. Rachael Kanguha, Pediatrician, Chuka County Referral Hospital, Kenya. Their groundbreaking work involved training machine learning models on the Pfizer ATLAS datasets and the development of a novel artificial intelligence web application capable of predicting antibacterial/antifungal susceptibility. Dr. Mutisya expressed his team’s commitment to AMR and highlighted the importance of providing equitable data accessibility to scientists from his region,

“Our team feels incredibly privileged to have participated in such a meaningful data challenge. Winning the grand prize not only fills us with a profound sense of fulfilment but also ignites a stronger motivation within us to continue seeking solutions for global issues, especially in combating antimicrobial resistance,” he said. “We are deeply grateful to Vivli for providing a platform that facilitates data accessibility. This is particularly significant for scientists like us hailing from the Global South, where opportunities like these are often scarce.”

Other notable awardees and their project titles include:

  • Impact Award Winner: Quentin Leclerc, Institut Pasteur, “Stronger together? Potential and limitations of combining industry datasets to fill in global AMR surveillance gaps.”
  • Impact Award Winner: Yanhong Jessika Hu, Murdoch Children’s Research Institute, “Global Geographic Patterns and Trends of WHO Priority Pathogens and AWaRe Antibiotic Resistance Among Children: amrinkids.com.”
  • Innovation Award: Robert Beardmore, University of Exeter, “Are antibiotic breakpoints globally consistent, and does it matter if not?”
  • Innovation Award Winner: Shraddha Karve, Ashoka University, “Novel approach to antibiogram analysis: looking at the composite resistance phenotype.”
  • Innovation Award Runner-up: Jacob Wildfire, LSHTM/SGUL, “Analysis of variations in minimum inhibitory concentration distributions by patient group.”

Data contributed by GSK, Johnson & Johnson, Paratek, Pfizer, Shionogi, and Venatorx was made accessible through the AMR Register, significantly enhancing the impact of the Challenge.

Prof. Marc Mendelson, Chair of the Vivli AMR Scientific Advisory Board, Professor of Infectious Diseases and Head of the Division of Infectious Diseases & HIV Medicine, Groote Schuur Hospital, University of Cape Town noted the exceptional quality of the Challenge applications,

“The quality of applications for the Vivli AMR surveillance Open Re-use Challenge was excellent and it is particularly exciting to see the innovative approaches used,” he said. “Ensuring open access to data across the spectrum of private and public sources is a fundamental key to driving innovation towards a better understanding of AMR and the mitigation of this global health crisis.”

Patricia Bradford, PhD, Antimicrobial Development Specialist and a member of the Judging panel spoke of the innovation of the solutions and their impact, “It was exciting to see the creativity of the various teams with regards to novel uses for the susceptibility data generated by the pharmaceutical industry.  Our hope is that these efforts will better enable patient care and foster antimicrobial stewardship on a local level.”

Alisa Serio, PhD, Executive Director of Microbiology and Nonclinical Development at Paratek Pharmaceuticals Inc. was impressed by the innovative approaches taken by the participating teams and noted, “The outputs of this challenge are exactly what the Vivli AMR initiative was set up for, specifically to openly share surveillance data for researchers to investigate a myriad of questions in AMR to help further understanding, decision-making and policy changes worldwide.”

For more details and to view the winning teams’ solutions, please visit https://amr.vivli.org/data-challenge/finalist-and-award-winning-solutions.

Contact: Catherine D’Arcy, Rebecca Li

About Vivli
Vivli is a non-profit organization working to advance human health through the insights and discoveries gained by sharing and analyzing data. Data sharing initiatives include the AMR Register for AMR surveillance data and the Vivli Platform for clinical trial data. Vivli acts as a neutral broker between data contributor and data user and the wider data sharing community. For more information, visit www.vivli.org and follow us on LinkedIn and Twitter @VivliCenter.

There’s more on Vivli than just clinical trial data

Did you know there’s more on Vivli than just clinical trial data? The majority of our repository of data comes from clinical trial data, but also includes significant numbers of platform trials, observational studies, and real-world evidence resources.

Vivli’s repository of data from nearly 7,000 research studies is available to search freely. Enter any relevant keyword and you’ll get a listing of pertinent studies of different kinds. Here are some recent search results using common keywords for studies that are not clinical trials: 

Observational: 198

Natural history: 26

Platform trial: 420

Explore our How To Guides to learn more about accessing and searching for data with Vivli. If you’d like to take your research further, you can get in touch with us for more information about specific studies or requesting access to data.

Vivli Researcher Spotlight: Dr. Neeraj Nerula on the use of Vivli’s platform to advance inflammatory bowel disease research


Dr. Neeraj Narula is an Associate Professor of Medicine and Staff Gastroenterologist at McMaster University in Hamilton, Ontario, Canada. His primary research focus is on inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. Dr. Narula is particularly interested in the endoscopic assessments of these diseases and understanding how to better quantify inflammation. He has devoted his efforts to devising ways to measure inflammation that provide meaningful prognostic value rather than arbitrary numbers.

One of Dr. Narula’s major contributions to research in this area has been the development of a scoring tool called the Modified Multiplier of the Simple Endoscopic Score for Crohn’s Disease (MM-SES-CD). This tool aims to better quantify inflammation in Crohn’s disease and provides higher weight to factors that are harder to heal. In contrast to previous methods, the MM-SES-CD shows great prognostic value and has shown potential in various clinical settings. Dr. Narula’s other interests involve data sharing platforms like Vivli. He values these platforms as a unique resource that younger investigators can access, helping them to answer key questions without the need for large-scale clinical trials. He encourages young researchers to leverage these resources to build their research profiles.

Dr. Narula believes that these platforms need some improvement in search functionality, making it easier for users to find specific trials. He also notes that learning how to interpret the data can be challenging initially; however, once this obstacle has been overcome, these platforms can be an invaluable resource. Dr. Narula’s ongoing research interests involve defining remission in Crohn’s disease and creating a similar tool for ulcerative colitis to the one he developed for Crohn’s disease. He is also working on validating the MM-SES-CD in unrelated datasets. He envisions these tools being incorporated into clinical guidelines in the future, ultimately improving patient care.

What led you to want to research this topic?

Inflammatory bowel disease (IBD) is a complex and multifaceted condition. While we have made significant strides in understanding IBD, there is still a lot to learn. The primary goal of this research was to delve deeper into patient response to various IBD treatments, to better personalize treatment plans and improve patient outcomes. The availability of an extensive dataset on Vivli allowed us to study patient responses in a more comprehensive manner than we might have been able to do otherwise.

What was your experience like in the process of requesting data using the Vivli platform? 

The process of requesting data through Vivli was straightforward and intuitive. The platform’s design made it easy to navigate, request the necessary data, and receive prompt responses. Vivli’s wealth of data provided an invaluable resource for our research

What is the current state of management in IBD? How was the data you accessed through Vivli able to help?

Current management of IBD largely involves a somewhat trial and error approach to medication. We aim to identify specific patient characteristics that predict response to particular treatments, enabling a more personalized, efficient approach to management. Access to data through Vivli allowed us to analyze a larger patient population and a wider variety of treatments than we would have been able to in a standard clinical setting.

How could your findings be used in future clinical trials on IBD? How can your findings be helpful in treatments for IBD patients?

We believe our research can help inform future clinical trials, guiding more efficient study design by highlighting potentially significant predictors of treatment response. Additionally, our findings can help clinicians make more informed decisions about treatment plans, ultimately benefiting IBD patients.

Would you use the Vivli platform again? What improvements would you recommend? 

Absolutely, the Vivli platform was instrumental in our research. In terms of improvements, perhaps a more detailed search functionality for the data could help researchers more quickly identify relevant studies. However, overall, the platform is user-friendly and efficient.

Please share any final comments about Vivli. What would you tell other researchers about doing this kind of analysis?

Vivli is a powerful tool for researchers in any medical field. The ability to access and analyze data from a vast array of clinical trials is truly invaluable. I encourage all researchers to consider using Vivli or similar platforms to enhance their studies, ensuring they have a clear research plan and question in mind to effectively leverage the available data.