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Applications of Master Protocols in a Global Health Context

Almost 3000 registered trials were performed in COVID-19 and a majority of them have been small and likely underpowered. There were a few new impediments such as lack of time to secure funding and the time taken by some of the Ethics Review Committees to prioritize COVID trials. In this scenario, adaptive trials have proven to be more efficient as they may require smaller sample sizes than a similar traditional trial. The flexibility to adapt sample size following interim analysis also allows sample sizes to be adapted as needed, avoiding underpowered trials. The most successful of these have arguably been platform trials like RECOVERY, SOLIDARITY and the Cytel-designed TOGETHER Trial.

Since the outbreak of the Pandemic, Cytel Vice President Real World Evidence and Senior Principal Scientist, Dr. Edward Mills, has been committed to finding therapies for COVID-19 that are widely and equitably accessible to all, including those who live in low- and middle-income countries (LMICs). Cytel designed and implemented the TOGETHER Trials to generate knowledge to help fight COVID-19, particularly in LMICs.

The TOGETHER trial is an adaptive platform trial evaluating interventions in COVID-19 among high-risk ambulatory patients. It has thus far evaluated eight different interventions and discontinued six of these early, saving time and resources. The platform research study, conducted from January to July this year, confirmed the benefits of fluvoxamine, an inexpensive drug currently approved as an antidepressant, for treating COVID-19. According to research study data, Fluvoxamine was found to reduce the number of COVID-19 patients ending up in hospital by approximately 30 percent.

Platform trials, such as those used to test fluvoxamine, are a type of Master Protocols that allow multiple therapies to be tested using a single study design with a shared control arm. This reduces costs and accelerates the overall process of establishing efficacy by several years, and ensures more patients are enrolled into arms containing newer medicines.

The TOGETHER Trial will hopefully open the door for wider adoption of platform trials and the use of advanced innovative approaches to designing and executing research studies.

Cytel is hosting a complimentary three-part webinar series focusing on Expanding Applications of Master Protocols. Dr. Mills presented the first webinar in the series: Master Protocols in a Global Health Context. In this webinar, Dr. Mills shares an overview of the challenges of conducting such a complex trial and the successes of communicating findings to important decision-makers.

Click the button to watch the on demand webinar.



About the Author of Blog:

Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.


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