2016-10-06 13:44:20 UTC

Functional Dyspepsia: Can We Get the Trial Design Right?

Oct. 6, 2016

Dr. Nimish Vakil discusses the need for improved definitions and clinical trials to develop treatment for this common condition.

In a new blog post on Applied Clinical Trials, Nimish Vakil, MD, AGAF, describes the need for a consensus on an "operational definition" of functional dyspepsia to use in clinical trials and help further drug development. Currently there is no specific therapy for the common condition.

Dr. Vakil, who is the co-chair of the 2016 AGA Drug Development Conference taking place later this month in Washington, D.C., says that the definition of functional dyspepsia has often been too restrictive or inclusive. This leads to poor patient participation in clinical trials and excludes those with the most severe symptoms. 

"Regulatory definitions of functional dyspepsia exclude patients with overlapping symptoms of gastroesophageal reflux disease and irritable bowel syndrome, which reduce the size of the study population and create a situation that cannot be translated into clinical practice," Dr. Vakil writes. He adds that along with an operational definition, the medical community must design goals for treatment to help improve clinical trial design and ultimately, treatment for patients with functional dyspepsia.

To learn more about the AGA Drug Development Conference, which is organized by the AGA Center for Diagnostics and Therapeutics, visit the conference website.

For more information on dyspepsia, visit the AGA Patient INFO Center.

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