Monday, November 12, 2007
The importance of communication and trust
I am still catching up on The New York Times Health section and I came across this article on clinical trial participants who never hear the results of the trials in which they have participated http://www.nytimes.com/2007/10/30/business/30device.html?ex=1351483200&en=168720f2e6ca47ba&ei=5124&partner=permalink&exprod=permalink. Congress recently passed a law requiring drug and device manufacturers to release the results of clinical trials for products that are on the market. But there is no requirement to release the information for drugs and devices that never make it to market. There are reasons for this of course, including not wanting to disclose results for products still in development for competitive reasons. But the failure to disclose results is particularly problematic for participants in device trials, who may end up with the device well beyond the duration of the trial. And if a participant develops complications and finds out other people had similar problems and the manufacturers and doctors involved in the research never disclosed such problems, it can breed mistrust among research participants. Communication is the key to making sure participants are fully informed about the risks and benefits of trial participation. Anything less than full disclosure opens the door to mistrust.
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