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Los Angeles, CA – January 22, 2013 – L.A.-based House Research Institute and Children’s Hospital Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children. The trial is a surgical collaboration sponsored by the House Research Institute in partnership with Children’s Hospital Los Angeles and Vittorio Colletti, MD of the University of Verona Hospital, Verona, Italy.

If your child is 6 to 12 years old, he or she may be eligible to participate in the ConnectMe clinical research program. The program includes three clinical research studies evaluating the safety, tolerability, and effectiveness of an investigational drug on social interaction and communication skills in children with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

For the melanoma patients who signed on to try a drug known as PLX4032, the clinical trial was a last resort. Their bodies were riddled with tumors, leaving them almost certainly just months to live.

But a few weeks after taking their first dose, nearly all of them began to recover.

NCRR awarded 18 grants to help determine outcome measures and increase the likelihood of success of future trials of treatments for children. The grants were awarded to 17 Clinical and Translational Science Award (CTSA) institutions to support 18 studies of pharmaceutical treatments for children. The CTSA consortium is a national network of 46 medical research institutions working together to improve the way biomedical research is conducted across the country. The $8.5 million in funding — administered by NCRR and provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development — will support studies which focus on three areas critical to health: pediatric cardiology, neonatology and pediatric neurology.