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Creative Minds: Designing Personalized Clinical Trials

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Karina Davidson

Karina Davidson/Credit: Jörg Meyer

It might have been 25 years ago, but Karina Davidson remembers that day like yesterday. She was an intern in clinical psychology, and two concerned parents walked into the hospital with their troubled, seven-year-old son. The boy was severely underweight at just 37 pounds and had been acting out violently toward himself and others. It seemed as though Ritalin, a drug commonly prescribed for Attention Deficit Disorder, might help. But would it?

To find out, the clinical team did something unconventional: they designed for the boy a clinical trial to test the benefit of Ritalin versus a placebo. The boy was randomly assigned to take either the drug or placebo each day for four weeks. As a controlled study, neither clinical staff nor the family knew whether he was taking the drug or placebo at any given time. The result: Ritalin wasn’t the answer. The boy was spared any side effects from long term administration of a medication that wouldn’t help him, and his doctors could turn to other potentially more beneficial approaches to his treatment.

Davidson, now an established clinical psychologist at the Columbia University Irving Medical Center, New York, wants to take the unconventional approach that helped this boy and make it more of the norm in medicine. With support from a 2017 NIH Director’s Transformative Research Award, she and her colleagues will develop three pilot computer applications—or digital platforms—to help doctors conduct one-person studies in their offices.


Reset Your Body Clock with a Camping Trip

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Photo of two people hiking along a wooded trail

Credit: Kenneth P Wright, University of Colorado at Boulder

School’s starting soon, and a lot of kids (and some adults) who were sleeping late this summer are struggling to reset their sleep cycles. All summer, those biological clocks have been getting pushed back. Artificial light allows us to work and play into the wee hours, interfering with the natural light-dark cycle that, over most of human history, began at sunrise and ended just after sunset.

But there’s a price to be paid for this modern shifting of biological clocks: research shows that long term indulgence in these late sleep schedules leads to unwanted weight gain and obesity, mood problems, substance abuse, and, of course, morning sleepiness. Light and sleep are critical to good health—and that’s one reason NIH funded a team at the University of Colorado Boulder to investigate the impact of natural light on our modern sleep patterns [1].