Ed Silverman, the brains behind pharmalot ( www.pharmalot.com) has written a great piece on the trend towards patient reported outcomes in clinical trials. Must reading on this subject for anyone interested in personalized medicine and understanding how and why FDA yanked the QOL indications from Amgen's anemia drugs.
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
