Half of US clinical trials go unpublished

Results are reported more thoroughly in government database than in journals.
by Nicola Jones
03 December 2013

The results of clinical trials are going unpublished as much as half the time, and those that are published omit some key details, a study has found. 

US law requires the results of medical research for drugs approved by the US Food and Drug Administration to be submitted to a database called ClinicalTrials.gov. Results, including adverse effects, have been made public there since 2008. Researchers who do not post results within a year of trial completion risk losing grants and can be fined as much as US$10,000 per day. But the database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.

In an analysis of 600 trials picked at random from the database, Agnes Dechartres, an epidemiologist at Paris Descartes University, and her colleagues have now found that only 50% had made their way into print. “Non-publication is a crucial problem for all stakeholders, from patients to health policy-makers,” says Dechartres. For one thing, she says, failure to publish results in journals breeches the implied contract with patients who participated in the trials. “If results are not [fully] available, we can consider that research wasted,” she says.

Click here to for full article on www.nature.com

In Eyes, a Clock Calibrated by Wavelengths of Light

"Researchers like Dr. Brainard hope the science may lead to a new generation of lights and screens designed with wavelengths that adjust according to the hour of the day."

click here to read full article on nytimes.com 

Otto Steininger

 

NEW STUDY: Cranial electrical stimulation (CES) and insomnia

Efficacy of cranial electric stimulation for the
treatment of insomnia: A randomized pilot study

R. Gregory Lande, Cynthia Gragnani
Click here for full study. 

Summary
Objectives: This pilot study examined the potential efficacy of cranial electric stimulation for
the treatment of insomnia.
Design: The researchers tested the hypothesis through a randomized, double-blind, and placebo
controlled clinical trial. The researchers approached eligible subjects who scored 21 or above
on the Pittsburgh Insomnia Rating Scale. The researchers then randomly assigned the subjects
to receive either an active or sham device. Each study subject received 60 min of active or
sham treatment for five days. Following each intervention the subjects completed a sleep log,
as well as three and ten days later.
Setting: The researchers conducted the study among active duty service members receiving
mental health care on the Psychiatry Continuity Service (PCS), Walter Reed National Military
Medical Center in Bethesda, MD.
Main outcome measures: The study’s primary outcome variables were the time to sleep onset,
total time slept, and number of awakenings as reported by the subjects in the serial sleep logs.
The researchers identified a nearly significant increase in total time slept after three cranial
electric stimulation treatments among all study subjects. A closer examination of this group
revealed an interesting gender bias, with men reporting a robust increase in total time slept
after one treatment, decay in effect over the next two interventions, and then an increase
in total time slept after the fourth treatment. The researchers speculate that the up and
down effect on total time slept could be the result of an insufficient dose of cranial electric
stimulation.

Published by Elsevier Ltd

Click here for full study.