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Why we should trust registered clinical trials

Credit: CC0 Public Domain

In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study in the Proceedings of the National Academy of Sciences (PNAS) brings good news about the credibility of registered clinical trials.

The authors are two Bocconi Professors of Economics, Jerome Adda and Marco Ottaviani, and a former MSc student of theirs, Christian Decker, now a Ph.D. candidate at the University of Zurich.

In a clinical trial, statistical significance is a key prerequisite for marketing approval of new drugs. Under a certain threshold of significance, the results of the trial could, in fact, be due to chance and not to the efficacy of the drug. Given the research costs involved and the lure of large potential profits by the sponsoring the trial, investigators may be pressured to beautify data, a standard argument goes. Previous studies of results of statistical tests reported in across a number of disciplines did actually detect an anomalous concentration of significance values immediately above the significance threshold, raising suspicions of selective reporting as well as manipulation.

Adda, Ottaviani and Decker concentrated their attention on the registered in ClinicalTrials.gov, the largest registry in the world, and focused on the differences in the results of phase II and phase III trials of the same drug. In phase II a drug’s efficacy is initially established in a small sample of people (usually in the low hundreds); in phase III safety and efficacy are then confirmed in a larger group of volunteers (usually in the low thousands). Reasonable expectations are that the of phase II will be confirmed in phase III and that trials that record a significance level under the threshold in phase II will be suspended.

Observing all

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Eye tracking technology holds promise for earlier autism diagnosis

What if you could diagnose autism just by looking at how a child’s eyes move?

While the technology is not quite that simple, an eye tracking system created by National Institutes of Health (NIH)-supported researcher Karen Pierce, Ph.D., and her team is paving the way for a simpler, more affordable tool for earlier diagnosis of autism spectrum disorder (ASD).

Dr. Pierce works at the University of California San Diego’s Autism Center of Excellence. Her lab receives funding from the National Institutes of Health’s National Institute of Mental Health (NIMH).

The screening tool, known as the GeoPref test, uses infrared light to follow a baby’s eye movement as they watch a series of movies showing geometric shapes moving around. The tool has successfully helped diagnose children with autism at just 12 months of age, and in only minutes instead of hours.

Why early diagnosis matters

Despite the findings of Dr. Pierce and other researchers that autism can be diagnosed in the first year or two of life, the average age of diagnosis in the U.S. is still 4 years of age. Diagnosis can occur even later in some racial and ethnic minority groups and in underserved communities, says Lisa Gilotty, Ph.D.

Dr. Gilotty is chief of the NIMH research program on autism spectrum
disorders
. Prior to her current role in overseeing funding for autism research at NIMH, Dr. Gilotty studied the disorder for decades and is dedicated to helping the more than 3.5 million Americans living with autism.

A major concern of researchers is helping children with autism get support fast—which comes from early diagnosis.

“The ultimate goal is to give people with autism the same opportunities, to live the life they choose to live.”

– Lisa Gilotty, Ph.D.

“A delay in diagnosis can have a profound cascading effect across