[soccertese]

http://medcitynews.com/2013/03/whats...investigators/

The fundamental problem, said Kenneth Getz, the director of sponsored programs for the Tufts Center, is the needlessly complicated design of clinical trials shaped by complex regulatory requirements from the U.S. Food and Drug Administration. Protocol design is an area the center has focused on for the past 10 years, according to Getz.

Read more: http://medcitynews.com/2013/03/whats...#ixzz2NWNBg7g3

[aj04]

The quote stopped short of including the final paragraph, which is important to get the full picture:

But while these innovations are helpful they are not addressing the root causes of the problem, Getz says. “They are point solutions — they touch on areas downstream, but don’t touch on root causes like regulatory burden and performance inefficiencies, and it is that protocol or blueprint that needs to be improved.”


The first paragraph, which is the only other paragraph missing, is also useful, for setting up the rest of the article:

Clinical trials are quite a complex undertaking to say the least. There are the sites to establish, the principal investigators to hire, the patients to recruit, the protocol to follow, interactions between the trial sponsor and regulators. And even when all the work is done as expected, the principal investigators frequently face challenges in getting paid on time, even after dealing with arduous contract negotiations in the first place. All of that contributes to the annual 40 percent turnover rate for these site investigators, according to a new study by Tufts Center for the Study of Drug Development.

Why is this OT? Doesn't OT mean Off Topic? What could be more On Topic?