“Vivli is delighted to have UCLA join us a member,” said Rebecca Li, Vivli CEO. “We look forward to working with its faculty and staff to support them in their data sharing efforts.”
For more information about the conditions for accessing UCLA data, please visit their member page. For additional information about Membership in Vivli, learn more here.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Please find linked above the proceedings and a recording of the meeting. This includes separate recordings of all panels and the keynote sessions from Dr. Robert Califf, FDA Commissioner and Dr. Monica Bertagnolli, NIH Director.
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.
Session topics will focus on the following areas:
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.
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
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
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
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
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
“We are delighted to have Servier, which is such an innovative organization that focuses strongly on research and development,” said Rebecca Li, Vivli CEO. “We look forward to working with the team at Servier to share their individual patient-level data to advance science.”
At Servier, we draw strength from our independence. We believe being free to make our decisions and adopt a long-term vision enables us to fulfill our vocation as a Group committed to therapeutic progress to serve patient needs. It makes us unique in the pharmaceutical industry.
For more information about the conditions for accessing Servier data, please visit their member page. For additional information about Membership in Vivli, learn more here.
“Vivli is delighted to have Stanford join with our other academic members to provide a simple, secure way for its researchers to meet the new NIH data sharing policy,” said Rebecca Li, Vivli Chief Executive Officer. “We look forward to working with the Stanford research community to make the data from clinical trials accessible to other researchers to continue to drive forward science.”
Vivli enthusiastically congratulates Dr. Monica Bertagnolli on her recent confirmation as Director of the National Institutes of Health.
Dr. Bertagnolli will become 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. Dr. Bertagnolli has also served as a long-time member on the Vivli External Advisory Committee.
“We are thrilled to hear of Dr. Monica Bertagnolli’s confirmation to such an impactful role. We wish her every success and look forward to witnessing her continued achievements,” said Rebecca Li, CEO.
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.
The World Health Organization (WHO) has identified Antimicrobial Resistance (AMR) as one of the top 10 global health threats facing humanity. Projections warn that antimicrobial-resistant infections have the potential to become the leading cause of death by 2050.
Recognizing the need for action on this pressing public health issue, Vivli joined forces with Wellcome in 2022 to launch the AMR Register. This innovative resource houses a growing collection of datasets shared by industry partners, offering consolidated access to surveillance data collected on dozens of antimicrobial interventions.
To raise awareness and encourage reutilization of this wealth of data, Wellcome funded the launch of the AMR Data Challenge in April 2023. The event offered a unique opportunity for multidisciplinary teams to access and leverage high-quality AMR surveillance data, and 56 teams from 28 countries submitted project proposals. The participating teams submitted a wide range of innovative proposals, making use of datasets contributed by GSK, Johnson & Johnson, Paratek, Pfizer, Shinogi, and Venatorx.
Submitted proposals were assessed by a judging panel of international experts, who selected six outstanding proposals for recognition as winners of the AMR Surveillance Open Data Reuse Data Challenge. The team that received the Grand Prize was led by 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. Their proposal notes that traditional methods of prediction have proved insufficiently dynamic to cope with the growing amount of genomic data available, or to effectively monitor and predict trends in antimicrobial resistance, leaving gaps in researchers’ understanding and ability to respond. Their goal is to showcase the best predictive model in order to enable proactive measures and early detection of emerging resistance patterns, and provide a model for ethically and effectively integrating AI into an evidence-based epidemiology approach.
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 fulfillment 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.”
Five other teams, including scientists from Australia, China, France, India, Spain, the United Kingdom, and the United States, were recognized by the judging panel for proposals which demonstrated notable impact and innovation. A complete list of the winning proposals and finalists is available on the Vivli AMR platform.
Members of the judging panel commented favorably on the excellent quality of the proposals submitted, the innovative approaches used, and creative solutions developed. One of the judges, Professor Marc Mendelson, also noted the importance of open access to data, calling it “a fundamental key to driving innovation towards a better understanding of AMR and the mitigation of this global health crisis.”
The Challenge is over for 2023, but the work of fighting AMR goes on. If you are interested in accelerating research and tackling a global public health challenge at the same time, explore Vivli’s AMR surveillance data sharing platform and find out how you can request access to data.