The TOGETHER Trial for COVID-19 therapies, designed by clinical trial specialists at Cytel Inc., has just won the Society for Clinical Trial’s annual Trial of the Year Award for 2021.
Designed with the view to rapidly test cost-effective therapies for low-income communities, the TOGETHER Trial used advanced statistical expertise to reach accelerated testing of eleven interventions, along with the deployment of clinical research infrastructure that will ensure that low-income communities can quickly find cost-effective therapies in the future. Since its launch nearly two years ago, TOGETHER has enrolled over 6000 patients in 22 research sites in Brazil. It is now expanding to Pakistan and South Africa, Rwanda, DRC and Vietnam.
Leading this effort was Cytel’s principal research scientist and Professor of Health Research Methods at McMaster University in Canada, Dr. Edward Mills. “We have a moral responsibility to ensure that COVID-19 therapies are both effective and accessible to the majority of people,” says Dr. Mills, “In a rush to find therapies that work, members of the global community failed to recognize that much of the world would not be able to afford a number of the therapies initially put forward for examination. Members of the TOGETHER Trial joined to ensure that low- and middle-income countries did not miss out on the global search for effective results. I see the recognition from SCT as a recognition of global scientific cooperation.”
The David Sackett Trial of the Year Award, named for the scientist long thought of as the father of evidence-based medicine, has been given every year since 2008. Award winning trials have to meet five critical standards of impact: the trial must improve the lot of humanity; a trial must offer a substantial, beneficial change in healthcare; the trial reflects expertise in both subject-matter and trial design while demonstrating concern for patients; the trial overcomes obstacles in implementation; and scientists working on the trial can provide a presentation of design, execution and results, that is a model of clarity and intellectual soundness.
Reflecting on the achievement, Josh Schultz, CEO of Cytel noted, “We are committed to designing clinical trials for human impact, and always appreciate being the strategic partner for those with visionary ideas for how new medicines, should get to patients faster. Our combination of innovative software, data resources, services capabilities and of course scientific expertise, partner together to make these unique and impactful trials possible.”
One of the challenges in COVID-19 response has been the typical multiyear timeframe it normally takes to secure scientific validity of clinical trial results. Using a design called a multi-arm adaptive platform trial, Cytel’s statisticians were able to shorten this time horizon from years to months, without compromising on scientific integrity.
According to Dr. Radek Wasiak, the head of Real World Evidence at Cytel Inc., “It was extraordinary to see scientists in the USA, Brazil, South Africa and Pakistan working in tandem to share results and generate solutions more quickly. TOGETHER Trial proves that the massive power of the private sector can be channeled towards these trials which were originally considered too complicated or high-risk for the private sector to coordinate.”
This study has been funded by FTX Foundation, the Bill & Melinda Gates Foundation, the Rainwater Charitable Foundation and FastGrants. More here.