Dr. Davidson’s project tackles a transformation needed in the clinical encounter to aid in the advancement of precision medicine.
Precision medicine aims to find the right treatment for each person, not the average patient.
“But randomized controlled trials only give us an average estimate of a therapy’s effect,” Dr. Davidson says. “They do not give us any information about which therapy is optimal for any given individual patient. Even for some of our most established treatments, only some patients obtain the expected benefit. Others get no benefit, or can even be harmed by these treatments.”
Conducting a randomized controlled trial in a single patient–an approach called a personalized trial, or an N-of-1 trial–promises to solve this problem, Dr. Davidson says. The ‘N’ refers to the number of patients in the trial.
In a traditional clinical trial, each patient is randomly assigned to a single treatment. In an N-of-1 trial, each patient receives both treatments, one at a time. Patients then monitor the effects of the treatments using the latest technologies, such as smartphones and wireless blood pressure machines. At the end of the personalized trial, patients learn which treatment worked best for them.
With her NIH Transformative Research Award, Dr. Davidson and her team will create an electronic platform that will allow clinicians or patients to order a single N-of-1 trial. They will then test the platform in patients with three common health conditions: high blood pressure, depression, and chronic insomnia. No single treatment for these conditions works for everybody, but if the treatments are tested in a personalized trial, a clinician can identify the right treatment for each specific patient.
“If our platform works, it could fundamentally change the clinical strategy for managing uncontrolled chronic medical and psychological problems and revolutionize the practice of medicine,” Dr. Davidson says. She is working with a team of collaborators at Columbia University Medical Center, including Ian Kronish, MD, assistant professor of medicine, and James Peacock, MD, assistant professor of medicine.
Since the inception of the NIH Director’s Transformative R01 program, five other CUMC researchers have received the award: David Fidock (2009); Milan Stojanovic and Hao Yan, (2012); Asa Abeliovich (2012); and Saeed Tavazoie (2015).