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    by Published on 08-22-2013 01:02 PM

    A team of researchers from Honda Research Institute in Mountain View, California recently won the A'Design Award Competition for a submission entitled: Projected Path Vehicular Augmented Reality. The team developed the augmented reality technology, and prototyped the design on a NADS miniSim Driving Simulator.

    Additional links are below:

    A'Design Award Description

    Article about the Augmented Reality Project

    Victor Ng-Thow-Hing's Website
    Published on 08-14-2013 12:02 PM

    As published in The New York Times

    August 13, 2013
    To Judge Sleep Aids, U.S. Looks at Drowsy Driving in the Morning

    The first test for a new sleep drug is — unsurprisingly — how safely it puts people to sleep. Now comes a second test: how safely it lets people wake up.

    The Food and Drug Administration is taking heightened interest in the issue, as new evidence suggests what many people have long suspected: the effects of common prescription sleep aids like Ambien can persist well into the next day. Of particular concern is whether people who take the drugs before bed can drive safely the next morning.

    Consumer advocates have warned for years about possible links between sleep drugs and car accidents. In one prominent example, Kerry Kennedy, the former wife of Gov. Andrew M. Cuomo, was arrested last year after tests showed she had taken a sleep aid before swerving her car into a tractor-trailer.

    The F.D.A.’s actions are part of a robust national conversation about how to cope with the throngs of drivers who take to roads every day under the influence of prescription drugs. Law enforcement authorities have struggled with how to prosecute those who are impaired, especially when they have a prescription. A government survey in 2007 found that nearly 5 percent of daytime drivers tested positive for prescription or over-the-counter medications.
    Doctors wrote close to 60 million prescriptions for sleep aids in the United States last year, according to the research firm IMS Health, but experts say testing how these drugs affect driving is not easy. Nonetheless, the F.D.A. has been unusually active.

    Last month, it rejected an application by Merck to approve a new sleep drug, suvorexant, in part because tests showed that some people had trouble driving the next day. In May, the agency warned patients taking common allergy drugs like Benadryl against driving, noting that the sedating effects can sometimes last into the following day. In January, citing similar concerns, the F.D.A. took the unusual step of requiring that all manufacturers of zolpidem, the generic name of Ambien, cut in half the dosage for women.

    The agency has since said that it is taking a closer look at all insomnia drugs on the market, and will ask manufacturers to conduct more extensive driving tests for all new sleep drugs. It will also more closely scrutinize any drug that causes drowsiness.

    Part of the problem is that the standard warnings on many drugs — against driving or operating heavy machinery — are often brushed aside. “It would be so convenient and it would be so good if you could just tell people, don’t drive unless you feel O.K.,” Dr. Ronald Farkas, the clinical team leader for the F.D.A.’s division of neurology products, told a group of industry experts at a conference in February. “I think this has penetrated now that this is not adequate. It is still good advice that, if you feel impaired, don’t drive. But if you feel fine, you might be impaired.”

    For years, traffic safety officials have called, without success, for a so-called “safe list” of drugs that do not affect driving. Some people react more strongly to drugs than others do, making it difficult to predict a person’s individual risk. And driving tests can vary significantly, like studies conducted on roads or those done in computer simulators.

    “It seems like a really simple question, but it’s really difficult,” said Dr. Matthew Rizzo, a professor of neurology at the University of Iowa, who studies driving abilities in people with cognitive impairments caused by conditions like Alzheimer’s disease.

    Pharmaceutical companies have long conducted driving tests for certain drugs, but the tests were motivated mainly by marketing goals and not seen as pivotal in getting a drug approved by the F.D.A., said Gary G. Kay, whose company, the Cognitive Research Corporation, leases a driving simulator to pharmaceutical companies. Mr. Kay, for example, helped conduct some of the research showing that the allergy drug Claritin did not cause drowsiness, unlike older antihistamines like Benadryl.

    Until recently, the F.D.A. evaluated driving tests by looking at the reaction of the average patient. But that thinking has shifted as research has shown that some people react more strongly to drugs than others, Dr. Farkas said in a telephone interview. “Some people have higher blood levels than others, and some seem to be more sensitive than others,” he said.
    In 2011, the agency recognized this variability when it approved the sleep drug Intermezzo, which treats patients who wake up in the middle of the night, in two doses: one for men and a smaller dose for women. Data had shown that the drug’s effects lingered in women for longer than they did in men. The agency’s experience with Intermezzo, along with other research, led it to order in January that the dosage for all drugs containing zolpidem — the active ingredient in Intermezzo, as well as Ambien and related generic sleep drugs — be halved for women.
    In the case of suvorexant, the Merck drug, four women had to stop the driving tests because of extreme drowsiness, and the F.D.A. concluded that the drug was linked to an increase of impaired driving among patients who had taken it. Last month, Merck said that the F.D.A. indicated it would eventually approve the drug if the company lowers the proposed doses.
    The attention has not been limited to insomnia drugs. In 2011, the F.D.A. approved the drug Horizant to treat restless leg syndrome after the drug makers, XenoPort and GlaxoSmithKline, conducted driving tests because the drug also causes drowsiness. Horizant carries a warning against driving until patients know how the drug affects them, and notes that the effects could last until the morning after it is taken.

    Dr. Eric Bastings, the acting director of the F.D.A.’s neurology drug unit, said the agency was writing guidelines to help pharmaceutical companies understand what is expected of them.
    Until then, however, there is a wide range in how pharmaceutical companies measure driving ability. The most well-established test takes place in the Netherlands, where participants drive in specially outfitted cars — and alongside a driving instructor — on open roads. It is the only place in the world where such tests are conducted on roadways.

    Drug companies still conduct the tests in the Netherlands — Merck’s drug was tested there, as was Intermezzo — but driving simulators are also growing in popularity. Dr. Kay’s company leases the MiniSim, a scaled-down version of a state-of-the-art simulator at the University of Iowa. Users sit in a dummy driver’s seat, complete with steering wheel and pedals, while three computer screens stand in for the windshield.

    Despite the increased scrutiny for sleep drugs, however, some sought to place the issue in perspective. “What we have to weigh here is that people who don’t sleep well are a hazard on the road because they do fall asleep while driving,” said Robert Voas, a senior research scientist at the Pacific Institute for Research and Evaluation and an expert on driving safety. “There’s risks on both sides.”

    Source: Driving Impaired: What You Don't Know and the FDA Does
    Publish Date: Mar 27, 2013
    Applied Clinical Trials
    By: Lisa Henderson

    It's easy to point to practices that are NOT driving safely. Driving too fast. Weaving. Texting or other inattentive phone-based behaviors. Use of substances that impair your function, like alcohol, illegal drugs and, yes, even legal, prescription drugs. It is easy to find information about alcohol impairment while driving. Also more data seems to publicly exist on Google search about illegal drugs and driving, for example, between 4% and 14% of drivers who sustained injury or died in traffic accidents tested positive for the active ingredient in marijuana (1).

    Again, these statistics are more easily found because of testing for illegal substances in driving accidents. But what about prescription drugs? In another study, opioids were present in 4.9% of fatally injured drivers, 4.1% tested positive for benzodiazepines and 2.7% for other psychotropic drugs. And while these medications affect systems in the brain that could impair driving, the most common label warning is “against the operation of machinery—including motor vehicles—for a specified period of time after use.”

    However, the following recent events are pushing the prescription drug and driving issue closer to the fore.
    • New Hampshire recently passed legislation to encompass prescription drugs in its definition for DUI, and went into effect January 1. (2)
    • The FDA recently told manufacturers of zolpidem containing drugs, prescribed for insomnia, to lower the recommended dosage on the label for women because of concerns of the risk for next-morning impairment, which are “activities that require alertness, including driving.” That risk is higher for women because their bodies apparently eliminate zolpidem more slowly than men. (3)
    • It was reported that the FDA will expand its use of driver simulation testing for sleep medications. (4)
    If the FDA is considering driver simulation testing as a real test for evaluating drugs, then can pharmaceutical sponsors be far behind for evaluation in clinical trials, or post-approval outcomes? The thing is, as detailed in this article driving simulation can be expensive. But it can also be more affordable, and amendable to clinical research, with the lower-cost PC-based simulator pictured.

    That solution, the NADS miniSim, will be on hand at this year’s DIA conference in Boston June 24-27. I for one plan to visit Cognitive Research Corporation’s booth and take a driving simulation test for reasons of a baseline cognitive function nature.

    Gary Kay, PhD is president of Cognitive Research Corporation, and co-author of this paper developed for the National Highway Traffic Safety Administration and released in March 2011. It details the potential of developing a list to indicate medications that may pose a hazard to driving, as well as those that could be prescribed more safely, using a standardized protocol.

    1. http://www.drugabuse.gov/publication...rugged-driving
    2. http://nhpr.org/post/nhs-new-dui-law...s-effect-jan-1
    3. www.fda.gov/drugs/drugsafety/ucm334041.htm
    4. http://www.philly.com/philly/blogs/p...ion-tests.html
    5. http://www.pharmexec.com/pharmexec/b.../detail/806582
    6. http://www.cogres.com/wp-content/upl...anelreport.pdf

    Full-Page article is here: Applied Clinical Trials_ Driving Impaired.pdf
    NADS MiniSim Contact: Andrew Veit: andrew-veit@uiowa.edu

    Source: Drugged Driving
    Publish Date: Feb 1, 2013
    By: Ben Comer

    Pharma is familiar with a lot of US government acronyms—HHS, FDA, CMS, SEC, DOJ, OIG, OPDP, and many more—but NHTSA (pronounced "nitzah") may not ring a bell. It stands for the National Highway Traffic Safety Administration, an agency housed within the US Department of Transportation. After years of asking questions and convening panels, NHTSA is moving closer toward the goal of establishing a "structured, standardized protocol for assessing the driving-impairment risks of drugs," pharmaceutical, OTC, and illicit.

    The issue of driving on meds gained greater visibility in early January, when FDA announced that it would require lower recommended doses of zolpidem, an atypical benzodiazepine best known as the sleep drug Ambien, and its generic predecessors. Pharmaceutical drugs, of course, aren't illegal when taken as prescribed, and they don't show up on a breathalyzer during a traffic stop. There isn't (yet) an FDA drug label that prohibits driving while using a prescription drug. But that doesn't mean patients taking certain antihistamines, antidepressants, benzodiazepines, and other therapies aren't driving around under these drugs' influence, to an extent that demonstrably increases the chances of a fender-bender, if not a full-blown crash.

    In November 2008 and again in March 2009, NHTSA convened a panel of international experts including behavioral scientists, epidemiologists, pharmacologists, toxicologists, and traffic safety professionals to determine whether medications, or classes of medications, could be designated as safe or unsafe for driving. If this determination could be made, the information would lead to better-informed prescribing practices, a more rational selection of medications by patients, and ultimately, fewer crash-related fatalities on American roads and elsewhere, according to the report.

    The panel's findings, described in NHTSA's "Drugged Driving Expert Panel Report: A Consensus Protocol for Assessing the Potential of Drugs to Impair Driving," dated March 2011, suggest a tiered protocol for a standardized and validated way to assess different kinds of impairment. In addition to pharmacological, toxicological, and epidemiological review, a drug must ultimately be put to the road test. Enter the $80 million National Advanced Driving Simulator (NADS), a warehouse-sized simulator completed in 2001 and located at the University of Iowa. This state-of-the-art simulator is one of the most advanced and immersive driving simulators in the world, but it's not exactly convenient, logistically, for use in clinical trials.
    The NADS miniSim, a lower-cost PC-based simulator, however, was designed with clinical applications in mind, and isn't stuck in Iowa. In fact, Gary Kay, one of the NHTSA expert panelists, and formerly director of the neuropsychology division of the neurology department at Georgetown University's School of Medicine, now heads a company called Cognitive Research Corporation, which has a worldwide exclusive license to use the NADS miniSim for pharmaceutical, food, and beverage clinical testing. Kay has served as principle investigator on clinical trials studying the effects of pharmaceuticals on cognition, mood, and psychomotor performance (he also invented CogScreen, a cognitive screening test used by, among others, the FAA, to assess the cognitive capabilities of pilots).

    Kay says FDA is interested in looking at other medicines and therapies (in addition to Ambien) and their effects on driving, and Cognitive Research Corporation is already working with major pharmaceutical players in the development of new drugs, and also in post-market research on existing products with the potential to impair driving. Generating data around a product's effects on driving can prove, in a validated, standardized way, that a product is safe (or safer than the competition), which could deliver a valuable selling point in crowded therapeutic areas, like sleep drugs, for example. Simulation isn't the same as "real-world" driving, of course, but hopefully it will help prevent drugged drivers in the real world from crossing into your lane.

    The miniSim, a PC-based driving simulator, evaluates levels of impairment.

    Full-Page article is here: PEFeb2013_backpage.pdf
    NADS MiniSim Contact: Andrew Veit: andrew-veit@uiowa.edu
    by Published on 01-17-2013 03:59 PM

    Philadelphia Inquirer: FDA to Require More Driving Simulation Tests

    Monday, January 14, 2013
    The millions of Americans who use sleep drugs were warned last week by the U.S. Food and Drug Administration to talk to their doctor about lowering the dosage of a commonly used type of insomnia drug in hopes that less of the drug will be in the bloodstream the next morning when the person gets behind the wheel to drive somewhere.

    IMS Health, a health care technology and information company with an office in Plymouth Meeting, said about 60 million prescriptions were written for all sleeping pills in 2011, with about two thirds of those being some form of zolpidem. The drug is sold as a generic and under the brand names Ambien, Ambien CR, Edluar and Zolpimist.

    “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” Dr. Ellis Unger, a director in the FDA's Center for Drug Evaluation and Research said in a statement. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”

    The FDA statement is here.

    One of the interesting things to spin out of the FDA teleconference with reporters was that Unger said the FDA would greatly expand its use of driver simulation testing for sleep medication. But that testing aspect might eventually also apply to other drugs that would impair drivers.

    The University of Iowa's National Advanced Driving Simulator says recently got a $650,000 research contract from the National Highway Traffic Safety Administration to research ways of detecting drowsy, distracted, and alcohol-impaired driving.

    A link to the NADS web site is here.

    Omar Ahmad, director of operations for the NADS, said this field of testing is going to expand. Critics will argue that any subject involved in testing will know that it is a simulation, but differences between how the subject functions with and without a substance can be distinguished.

    "We have researchers at Iowa looking not just at sleep drugs, but testing protocols for entire classes of drugs," Ahmad said. "Researchers looking at the relationship and effects of CNS - central nervous system - drugs and whether they can affect people when they drive."

    But science and testing can take a long time to eventually arrive at simple messages, so Ahmad offered a good one.

    "If I can offer a public service message here," Ahmad said, "we as individuals, really any person using a drug, needs to talk with their doctor about when and how a drug might affect their ability to drive, or a combination of drugs. Not that a doctor can be fully aware of all the combinations, but asking the questions, having the conversations, would be a good first step."
    by Published on 03-30-2012 09:13 AM

    NADS along with faculty, staff and students from all the colleges of the University of Iowa participated in the Hawkeye ...
    by Published on 07-26-2011 12:58 PM

    UI Develops Simulated Driving Platform for Teen and New Drivers
    July 14, 2011

    University of Iowa News ...
    by Published on 04-09-2011 02:41 PM
    Article Preview

    NADS along with faculty, staff and students from all the colleges of the University of Iowa participated in the Hawkeye ...
    by Published on 02-13-2011 02:13 PM
    Article Preview

    Students test effects of
    energy drinks on driving

    Simulation finds beverages negatively
    affect new
    by Published on 12-16-2010 04:50 PM
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    We often receive requests for traffic-safety related posters and information. The following are posters that we have displayed ...
    by Published on 06-10-2010 09:43 AM
    Article Preview

    On June 4, we attended the 2010 Southern California Transportation and Logistics Summit hosted by the Leonard Transportation ...
    by Published on 05-02-2010 01:27 PM
    Article Preview

    A BGM High Schol Senior, Caitlyn Reynolds is very concerned about the danger that distracted driving due ...
    by Published on 04-16-2010 01:56 PM

    Come vist us at the National Advanced Driving Simulator's open house at the College of Engineering!

    April 22, 2-4pm, Room 1501A in the Seamans Center

    See Attachment for details.

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