Science & Research (Drugs) > A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

Science & Research (Drugs) > A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

FDA CDER statisticians are designing trials with adaptive features to make clinical evaluation of new drug treatments more efficient and informative

In 2014, FDA Center for Drug Evaluation and Research (CDER) statisticians and their collaborators at NIH and in West Africa faced the challenge of designing a trial to assess treatments for Ebola virus that could be conducted in a medical emergency. In their design, they used a Bayesian approach that include options for adaptations of the trial due to rapidly changing events on the ground and newly acquired information about the disease.

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Note: FDA is continuing our work to help expedite the development and availability of medical products – such as treatments, vaccines, diagnostic tests, and personal protective equipment – with the potential to help bring Ebola outbreaks under control as quickly as possible. You can find the latest at Ebola Preparedness and Response Updates from FDA.

Images (left to right): Scanning electron micrograph of Ebola virus (credit: NIAID); doctor checking patient vital signs; U.S. Public Health Service officers celebrate as a Liberian man adds his handprint to a “survivors’ wall.” Each patient who overcame Ebola after treatment at the USPHS mobile hospital outside Monrovia during the 2014-2015 Ebola epidemic was given a set of clothes and essentials and invited to mark their recovery with a handprint (photo: FDA)

Related links: Statistical Considerations for a Trial of Ebola Virus Disease Therapeutics, published in Clinical Trials, January 2016 MCMi Extramural Research, including additional Ebola-related projects funded by FDA