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Top institutions not reporting clinical trial results as required. Stanford University, Memorial Sloan Kettering Cancer Center, and other prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found. The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer. The worst offenders included four of the top 1. National Institutes of Health: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego. All disclosed research results late or not at all at least 9. Failure to Report: A STAT investigation. What we found: Most research institutions . But while the industry generally performed poorly, major medical schools, teaching hospitals, and nonprofit groups did worse overall . It could have collected a whopping $2. But it has not levied a single fine. The STAT investigation is the first detailed review of how well individual research institutions have complied with the law. Read More. Special Report: Popular heart surgery carried hidden danger The legislation was intended to ensure that findings from human testing of drugs and medical devices were quickly made public through the NIH website Clinical. Trials. gov. Its passage was driven by concerns that the pharma industry was hiding negative results to make treatments look better . We then asked the question, how can they get away with this? Francis Collins acknowledged in a statement that the findings are .
This visualization shows the first comparative analysis of their performance. Among the groups, just two companies provided trial results within the legal deadline more than half the time. Percentage of clinical trials by entity that have late or no results: Doctors rely on robust reporting of data to see how effectively a drug or device performs and to understand the frequency of side effects such as suicidal thinking . Researchers depend on prior results to plan future studies and to try to ensure the safety of volunteers who participate in trials. Yet academic scientists have failed to disclose most results on time . They said that they are simply too busy and lack administrative funding, and. Some experts voiced concerns that the researchers might also face pressure from corporate sponsors to delay reports . The results of tests involving breast and colorectal cancer patients showed serious adverse effects in 1. They included heart, liver, and blood disorders, bowel and colon obstructions, and one death. The New York City hospital said it delayed its reporting so that it could complete related medical journal articles. It rushed to submit the results to Clinical. Trials. gov only after being contacted by STAT . Houston, who directs clinical research operations for Memorial Sloan Kettering, said she believes the researchers did immediately report adverse events to Synta and the Food and Drug Administration. But a hospital spokesperson said records needed to verify if that happened were no longer accessible. Houston said that Synta, which paid for the research, normally would alert investigators on other ongoing trials of the same drug about adverse events, so they would learn of the possible added risks to patients despite Memorial Sloan Kettering. In 2. 00. 9, the nonprofit Hoosier Cancer Research Network terminated a study of Avastin in 1. But the Indianapolis- based network, which runs trials under contract for drug companies, did not report the results as required the following year . The Hoosier Network researchers finally published the data in a medical journal in 2. They have yet to post results on Clinical. Trials. gov . Kathy Miller of Indiana University School of Medicine, blamed . She insisted that her study . Overview of Clinical Trials What is clinical research? Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and. ExPORTER NIH Intramural Research Database Report Catalog NIH Recovery Act Grant Awards Federal RePORTER ClinicalTrials. Gene Therapy Clinical Trials. The Australian Government is undertaking initiatives to improve the clinical trials environment in Australia and through which increase Australia’s international. The analysis focused on the 9. Sept. 1. 0 of this year. None of the organizations has much to boast about. More than one- fourth of companies did better than all the universities and nonprofits. The FDA, which regulates prescription drugs, is empowered to levy fines of up to $1. Clinical. Trials. In theory, it could have collected $2. But neither FDA nor NIH, the biggest single source of medical research funds in the United States, has ever penalized an institution or researcher for failing to post data. Even the agency. Counting results reported late, NIH staff performance reached 9. Read More. FDA official took name off papers Beginning next spring, after further refinement of Clinical. Trials. gov rules, NIH and FDA will have . Lisa Lapin, a top communications official at Stanford, said via email that many faculty members find the process for entering results . Professors supplied data on time for only four studies. Dr. Harry Greenberg, senior associate dean for research at Stanford, said his institution was determined to improve. Eli Lilly has seven full- time employees for the task. But Collins and advocates for transparency said time demands are no excuse for noncompliance. Paul Sabbatini, a research executive at Memorial Sloan Kettering, said that as an efficiency measure, his organization previously tried to complete work on scholarly publications in tandem with reporting Clinical. Trials. gov results. The hospital will now post to Clinical. Trials. gov independently. Several organizations argued that publishing in peer- reviewed medical journals is the highest form of disclosure of study results and should be sufficient, or that there should be a way to simply copy journal data into Clinical. Trials. gov. Critics say such views reflect the primacy of scholarly articles for academic career advancement more than any inherent superiority over Clinical. Trials. gov. A 2. PLOS Medicine compared 2. Clinical. Trials. The NIH registry proved far more complete, especially for reporting adverse events . They publish relatively few negative results, although failed tests can be as important as positive findings for guiding treatment. Clinical. Trials. The website is open to the public, unlike many journals that charge a substantial fee. And the site requires data to be entered in a consistent way that allows easier comparisons of benefits or side effects across many studies. It also lets experts check whether researchers have cherry- picked results, which can mislead doctors and patients. Preliminary work by The Compare Project, at the Centre for Evidence- Based Medicine at the University of Oxford, suggests that shifts away from outcome measures designated before the start of a clinical trial to results selected at the study. The group recently examined reports in leading journals on 4. Withheld data spurred action. Congress passed a law requiring registration of clinical trials in 1. Clinical. Trials. At first it was little used. NYU’s Miller traces the origins of stronger reporting requirements to Spitzer. This past September, the medical journal BMJ reanalyzed clinical trial data gathered by the company in 2. Its findings showed Paxil to be no more effective in teens than a placebo, and linked the drug to increased suicide attempts. Scenarios similar to the Paxil case have been repeated many times since with other drugs. In the wake of the bird flu scare a decade ago, governments stockpiled billions of dollars worth of the antiviral drug Tamiflu, thought to be a lifesaver. The Lancet reported last year, however, that previously undisclosed trial data showed that Tamiflu . All immediately fell gravely ill. One suffered heart failure, blood poisoning, and the loss of his fingers and toes in a reaction that resembled gangrene. A close variant of the drug had been found potentially dangerous years earlier, but the results had never been published. In response to Spitzer. The move prodded competitors and lawmakers to do better. Then in 2. 00. 7, a new US law broadened trial registration requirements and added mandates for disclosing summary data, adverse events, and participants. The site logs 2. 07 million monthly page views and 6. An NIH survey suggested that 8 in 1. With a $5 million budget, the program. More than 2. 00,0. Clinical. Trials. US test site, those involving nutritional supplements, and early safety trials. Study sponsors can also request permission to delay reporting on experimental drugs not yet approved by the FDA, and have done so on more than 4,3. The many exceptions mean that virtually all research organizations . Just 2. 5 of those required the reporting of results by law. Even for that small number, Abb. Vie achieved its relatively good reporting record not from exceptional efforts on public disclosure, but by diligently applying for filing extensions. Biogen delivered results late or not at all 9. It said that many of its studies were not covered by the reporting law, and that it had extension requests pending or planned for others . But STAT did not count trials exempted from the law, nor those that NIH listed as having applied for extensions. Read More. Drug makers need to disclose more clinical trial data, study says The reporting of results on Clinical. Trials. gov, poor by any reasonable standard, is worse than it appears, some researchers say. In part, that. A research organization that appears conscientious in reporting results might be hiding some trials. NYU’s Miller studied drugs from major companies approved by the FDA in 2. In a recent article in the medical journal BMJ Open, she and her coauthors showed that trials subject to the legal requirements often were not registered, and results not provided . Ben Goldacre, a fellow at the University of Oxford and cofounder of The Compare Project and Alltrials. 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I tell you otherwise, ha!). If they have a connector on a board, and it is burnt. Do you know what an amp or volt is? Are you scared to look under. Think about all of this. Before Beginning: Should you attempt Printed Circuit Board (PCB) repair? But fixing printed. Do not work on. circuit boards! Send them out for repair to a professional. So if a. board is made . In some cases, it is. Do not think because. Do NOT become. over confident. Before Beginning: How did you learn to solder? A sloppy. job won't really affect much. Sloppy soldering on a. A circuit board can be totally ruined with. Also the equipment and techniques are a bit different. My dad taught me. I was probably 1. I thought it was fun! Mercedes Tools - any Special Tool for Mercedes Benz Repair from Samstag Sales. For R&R of the grooved nut on the rear axle shaft flange, or when replacing. Then I soldered the points where the. When I was done, it was a pretty. D box, and I was proud. 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Due to the. vibration of solenoids and players in a pinball machines. It happens, and the owner. Get a soldering. station and some good quality solder (as decribed below). That is, the wire should be mounted to the coil. The soldering iron can then. Now keep the solder joint steady while it cools. Video. game collectors can often provide some. JAMMA games board or other boards. Maybe there's an old. PC computer (which you couldn't give away!) that's could be used. Even if one has to pay for some junk boards. Practice soldering the resistors to the. This is not as good practice as using a real printed circuit. Remember to. clean the copper on the Radio Shack board with some Scotchbrite before trying. Tools Needed: Good Lighting and Magnification. If there isn't good light in the workshop, go to. I personally like florescent light for repair work. One is worn on the. To focus. move your head to a certain distance from the viewing object. The. other (more desirable in my opinion) magnifier is on an adjustable. This is what I personally. I find it extremely useful for finding circuit board. MCM Electronics (8. This is a nice. version with a built in circular florescent lamp. There is also a cheaper. This hand- held device works well too, and can fit. It has a high intensity bulb with a switch. Tools Needed: Get a good Soldering Station. There is NO way around that. Don't be cheap (unless. Buy a Good Soldering Station. Your dad's old soldering gun isn't going to work for soldering circuit boards. The best way. to do this is with a quality soldering station. Also they are grounded nicely, to isolate. Weller. even makes a nice . If. you are really on a budget, the Tenma brand (import) is decent too. I personally. use a Weller station for my workbench, and use a Tenma for the garage. Which ever. you get, buy some extra soldering tips! Soldering is best done at. I usually solder at about 6. This is far less useful. So a 2. 5 watt soldering iron is always running at. ALWAYS generating heat. The soldering iron's tip absorbs the heat. As. long as power is supplied the tip will continue to get hotter until it. As soon as. a soldering iron's tip makes contact with metal, heat will transfer. The higher the wattage iron, the quicker the tip. When a cheap soldering iron is idle, it is MUCH HOTTER. But the moment you place it on. For this reason, if. That's why a good soldering station. The right temperature can be dialed in. Then the. station will monitor itself, turning power to the station's soldering tip. Tenma also has a digital display version of. This model has adjustable temperature. The. Weller brand will cost a bit more, but is probably worth the extra money. Don't go higher than 2. It is rated at 2. The Weller SP2. 3 works. EM and Solidstate games, and . But remember the warning. Tools Needed: Get good solder! The best solder is made by Kester (USA made). Here are the solder specs you need. Rosin flux core. No other core will suffice! Any other type of flux will not work for. For example, acid flux is designed for plumbing. Anything bigger than . Some people like. But personally I don't see the need for it. Tools Needed: De. Soldering Tools. When pricing desoldering. Often the price of a new tip can. And a new tip will be needed at some point. Personally I tend to go . As the braid heats. When you're done. Usually it takes more heat to. Also it's not very fast. If doing a lot of unsoldering. It works OK with large. But when desoldering say a chip with small leg holes. I find the braid difficult to use. I personally. don't recommend it or use it, but it does work in a pinch, and it's inexpensive. After letting this iron warm up for about 1. Then put the hollow tip over the joint to. After the solder has melted (a couple seconds), release the. An easy. one handed operation that requires minimal practice. Because of this, the Radio Shack. Too much heat, and the traces. Just keep. this in mind. Remember, it is a 4. It's hard to beat for the price, and I personally. Because of this, I would not recommend this tool. They sell. two styles of tips; get the . A clogged or enlarged tip on this. It's. a large syringe type desoldering device with a Teflon tip (get a replacement. Teflon tip when buying this tool). The downside to this tool is. TWO hands (one to hold your soldering iron, and. Soldapullt). The anti- static version would be preferred. Because of this, I highly recommend the Soldapullt tool for. But remember, practice is necessary to use it! These. consist of a small suction pump, connected to a soldering. They work much like the Radio Shack. These work the best. If working on any. FAR easier, faster, and less problematic. It has a self- contained vacuum pump, and. This is a great desoldering. I personally use this tool as a . Temperature. is adjustable via a small pot, but it's more designed to be set once. Takes about 5 minutes to warm up and is ready go. When finished and the tool cools. I have been using this tool for several. Just make sure it warms up for 5 minutes. It is a self. contained station with its own compressor. Again I would recommend . The filter could be as. NOT use synthetic cotton, as it will. Have some spare filters around, and. Another. replacement item is the rubber gasket that seals the solder collection. With time these dry out and fall apart. So it's not a bad idea. These are used to clear the desoldering tip. It's a good idea to have one of. Almost. guarenteed the station will need a new tip, a new filter, and. Sometimes the heater. So ask questions and check out the. Also remember, a used. But good deals can be found because many. Get some junk. circuit boards, and remove some components from them. That. way you won't be experimenting on . Also see the section below on. Tools Needed: DMM (Digital Multi Meter). DMM stands for Digital Multi Meter. This tool is used more than any other in pinball. DMM's do lots of good things. Test for . It's probably the single most valuable tool. But for pinball repair purposes. Manual ranging meters require. For example. if testing a 1 meg ohm resistor, but the meter is set to the. All the user needs to do. An auto ranging DMM will cost more. It takes a moment longer to test a component on an autoranging. DMM. This extra time means nothing, *unless* using the meter. For example, a voltage that goes up. An auto ranging DMM won't be. A manual range DMM would work much better here. These allow aligator clips to be screwed to the ends. DMM easier. If your meter doesn't. Having. a nice DMM is something will be appreciated. For $6. 0 or. more, a pretty nice meter can be bought. I find that if. the meter has a rubber . Also the meters. that have an available . Tools Needed: Logic Probe. Basically, a logic probe is a. Simply put, a. electronic pinball game is a computer. Computers (at a low level). The relationship between these two signals (voltages) is important. A logic probe can show if a particular. The. logic probe shows this with three LED's, and sometimes a buzz tone too. Some logic probes are faster than others. For pinball, get one. Hz (or faster), but most can do that. Also. some probes emit a tone in addition to the LED's, which is a nice feature. MCM Electronics. (http: //www. Tenma logic probe with memory, part number 7. It is a 5m. Hz (DC band width. LCD display screen, which draws a picture of the signal. Tools Needed: Hand Crimpers. A hand crimper allows. Molex connector pins, which are. Also needed will be connector. These are used for all the different styles of. Molex terminal pins. Aeroelectric's terminal tool BCT- 1, available from. Catalog/tools/tools. Molex crimper #6. Molex crimper #1. Waldom/Molex crimper WHT- 1. How to Use It: Electronic Schematic Symbols. How to Use It: Short Course in Transistors. There are several types. A single Pentium chip has about 3. If a current is. flowing to the Base, there will be a path from the Collector (C) to the. Emitter (E) where current can flow (the switch is on). If there is no. current flowing to the Base, then no current can flow from the Collector. Emitter (the switch is off). So a small change of current on the base, results. Collector and Emitter. The NPN transistor's arrow. PNP = Pointing i. NPointer. The PNP transistor's arrow points in. This means a NPN transistor has a higher frequency response than a PNP. That is, the base is always about . We will see this come into play when we test transistors. DMM (digital multimeter). This is. known as a Darlington pair, and can be used as any single transistor would be used. The advantage to this style of transistors is it has a larger. Darlingtons can handle. When the base is turned off. How to Use It: Short Course in Logic Chips. This document will not give. Find pin one, because this is the reference point for all. 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