The FTX Foundation supports the global expansion of the Trial of the Year award winning TOGETHER Trial

Innovative adaptive platform approach game-changer for the way clinical research is conducted

SAN DIEGO, May 16, 2022 /PRNewswire/ - The FTX Foundation proudly announces financial support for the global expansion of the TOGETHER Trial on the same day that the trial investigators receive the prestigious Trial of the Year Award from the Society for Clinical Trials (SCT) in San Diego.

Each year the SCT presents one award for a randomized clinical trial published the previous year that best exemplifies five key criteria including improvements to humankind and provides a basis for substantial and beneficial changes to health care. The TOGETHER Trial is the largest placebo-controlled COVID-19 trial and has, so far, evaluated 11 different treatments for COVID-19. On May 16, the TOGETHER trial receives the award and announces more than $18 million in funding and purchase commitments from the FTX Foundation that will enable the expansion of the trial from Brazil and Canada, to include experienced sites in South Africa, Rwanda, the Democratic Republic of the Congo, the Bahamas, Pakistan, Vietnam, and Ghana.

"We are incredibly honoured to receive this award and to work with the FTX Foundation. The TOGETHER Trial is truly an international collaboration and this award is a tribute to the entire team and also the patients who participated," said Dr. Edward Mills, Co-principal investigator, TOGETHER Trial, Professor, Health Research Methods, Evidence and Impact, McMaster University. "COVID-19 is an unprecedented modern-day pandemic that called for a bold, novel and innovative approach. Partnering with innovative thinkers at the FTX Foundation allows the rapid expansion of our trial that will have major benefits to public health around the world. With the support of the FTX Foundation, we can now also start evaluating drugs for future pandemics."

"The FTX Foundation is excited to commit $15 million to funding additional trial arms in the TOGETHER Trial and its growing global network of sister trials," said Ross Rheingans-Yoo, from the FTX Foundation. "Our initial $3.25 million grant to expand the trial network's core infrastructure has helped bring the model from Brazil to key sites across the globe, and we look forward to finding further opportunities to support the consortium's growth and help prevent future pandemics." Pandemic preparedness is a priority of the FTX Foundation and reflected in their initial support of many projects in the space.

The TOGETHER Trial is a new research approach that is randomized, perpetual and adaptive. Some unique features of the successful adaptive platform approach include:

• The ability to review data as it emerges from the study in real-time, rather than waiting until the end of the trial;
• Quicker responses to emerging trial data, allowing investigators to make the trial safer for participants;
• Multiple treatments against a condition at the same time using only one control group;
• The ability to halt trials for specific treatments sooner if the data suggests they are not working and then introduce new treatments to the trial.

Adaptive platforms save both valuable time and money. These efficiencies led to the faster development and approval of new treatments, which in turn translate into more lives saved around the world. Creating the infrastructure for adaptive trials in lower resource settings is paramount to building pandemic responses in these settings.

In less than two years, the team of researchers have created the world's largest placebo-controlled COVID-19 trial, successfully recruiting more than 8,000 patients in community-based settings and establishing 22 sites across Brazil. Led by Brazilian scientist Dr. Gilmar Reis, the data gathered from these patients contributed to the evaluations of 11 different potentially life-saving therapeutic interventions.

The unique partnership now between the FTX Foundation and the TOGETHER Trial has already had a direct effect on the way global clinical research is conducted, bringing about substantial positive health care changes that will be felt well beyond the COVID-19 era.

About the TOGETHER Trial
The TOGETHER Trial consortium consists of representatives from a diverse spectrum of global and national institutions, including academic, professional membership, industry and private sector, multinational, and philanthropic agencies. Academic partners include McMaster University (Canada), Stanford University (USA), University of Witwatersrand (South Africa), Aga Khan University (Pakistan), University of Global Health Equity (Rwanda) and the Pontifical Catholic University of Minas Gerais (Brazil).

The TOGETHER Trial consortium additionally includes representatives from the World Health Organization (WHO) Clinical Guidance Committee on COVID-19 Therapeutics. The TOGETHER Trial is also supported by funding from the Bill & Melinda Gates Foundation, FastGrants for COVID-19 Research, the Rainwater Charitable Foundation, and Unitaid.

For more information on the TOGETHER Trial please visit www.togethertrial.com

SOURCE TOGETHER Trial