Seattle, WA. The COVID-19 Therapeutics Accelerator donors and partners announced the formation of the International COVID-19 Data Research Alliance to accelerate clinical research on COVID-19. Composed of academic institutions, research organizations, life sciences and technology companies, and philanthropies, the International Alliance was created to fight the COVID-19 pandemic, but with the promise for use across other health conditions, including readiness for future pandemics.
Accelerator donors, including the Bill & Melinda Gates Foundation, Chan Zuckerberg Initiative, Mastercard, Minderoo Foundation, and Wellcome, will be founding members of the International Alliance. It will be managed by Health Data Research UK, a national institute for health data science with expertise in harnessing data at scale to improve people’s lives, working in partnership with alliance partners from life science companies, academic institutions and clinical research organizations from around the world. The announcement came on June 26th.
In May at the Coronavirus Global Response Summit, the Bill & Melinda Gates Foundation announced a commitment of $125 million towards the international collective effort to develop and equitably distribute COVID-19 diagnostics, therapies, and vaccines. This includes $50 million of new funding to Gavi, the Vaccine Alliance and $75 million of previously announced funding for therapeutics and diagnostics.
The current pandemic has prompted a great deal of research, but there are few environments where data sets generated by previous studies and trials can be accessed to inform research and development efforts. These data sets could address key questions about the course of COVID-19, how it impacts the body, and what treatments might be effective. In many cases, relevant data sets exist, but researchers cannot easily access or link them for integrated analysis. The International Alliance will provide a variety of ways for researchers to collaborate on data—from pooled to federated analyses—for trustworthy, privacy-protected, and ethical research as determined by a governance board of global specialists in the field.
“In a pandemic, the pathogen has the upper hand. We know very little about it, so access to information becomes an important commodity,” said Trevor Mundel, president of global health at the Gates Foundation. “By entering into agreements on data sharing up front, we can avoid wasting time going down blind alleys, ultimately saving lives by getting definitive answers to key questions more quickly. This grant to form an international data alliance will accelerate efforts and provide a legacy for future collaboration on pandemics. We encourage others to join us and the other founding partners in this important initiative.”
Answering Research Questions About COVID-19
The Therapeutics Accelerator has also funded the development of a COVID-19 Workbench to support the International Alliance by creating a trusted research environment for access to global multidimensional data sets. This will enable researchers to work with the data to answer questions of high importance to the community. These questions, formed into driver projects, will address two key challenges for COVID-19 clinical care, as a start.
Understanding who is at highest and lowest risk and what they can expect from the disease is of paramount importance. The Workbench will enable the use of state-of-the-art techniques to explore characteristics that influence disease progression and impact treatment outcome in patients. It will also work to establish which drug treatments are most likely to be effective and when to administer each treatment during the course of care.
According to the Global Coronavirus COVID-19 Clinical Trial Tracker, there are currently 1,570 ongoing trials studying more than 50 drug interventions. Bringing data from these trials together with this federated workbench provides researchers with a more complete understanding of each intervention’s safety and efficacy. The International Alliance will first focus on creating summaries of the trial data (e.g., overall results, patient subgroups, specific endpoints) and use meta-analysis methods to provide side-by-side assessments of the drugs being studied. This way, researchers will have access to insights from all the available trials at once rather than relying on insights from a single trial at a time. As the International Alliance secures more data, additional research questions will be assessed.
An Analytical Workbench for Scientific Inquiry
The Workbench will connect to regional and national data infrastructures used by International Alliance members, such as data generated by Therapeutics Accelerator-funded trials, pharmaceutical industry partners, the national BREATHE health data research hub in the United Kingdom, SAIL Databank and others to be confirmed in the coming months. The Workbench, developed by Aridhia Informatics, will enable the discovery of data relevant for answering priority questions from its own repository and federated repositories, and will provide a secure location where analysts can work collectively on a target research hypothesis. Data access and use will be conducted in accordance with the governance requirements of individual data controllers from countries around the world, in a transparent and ethical manner. Authorized users will be able to bring their data to the Workbench and collaborate with others in a secure environment. The Workbench will be designed to encourage and enable responsible data use, including transparency, ethical review, privacy, and data protection.
“The UK has established a robust infrastructure for uniting, improving, and using health data for research and innovation. We are excited to build on this experience of our community and partners to support this vital global effort against COVID-19 and future outbreaks,” said Graham Spittle, chair of Health Data Research UK. “Recent controversies about the safety and effectiveness of new treatments in the treatment of COVID-19 highlight the need for the international community to work in partnership to analyze rapidly the results of multiple clinical trials at scale. The International Alliance aims to enable this in a trustworthy way. We look forward to working in partnership with, and learning from, colleagues internationally.”
About the COVID-19 Therapeutics Accelerator
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer term.
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
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