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Some elements of this article are a bit off (for example, all clinical trials are not meant to inform practice, as in Phase I & mechanistic trials), but the basic findings are consistent across multiple studies.
Dr. Woodcock at FDA coined the term SCT (small, crappy trials) to characterize many of the trials done in academic centers--too small to answer meaningful questions, many with poor designs & no analysis plan. These SCTs often aren't finished & aren't published.
If all people enrolled in SCTs enrolled in quality trials, we'd be a lot more knowledgeable about appropriate treatment. Frustrating to see the lack of attention to the ethical issue of doing a human experiment with no chance of creating meaningful knowledge.
I think its time for FDA to fine a few offenders to wake up the academic community. A couple of fines would probably do the job.
Also feel compelled to point out that FDA has limited people to do enforcement and many more egregious issues are not fully addressed because there are only a limited # of lawyers & if they are tied up on this other critical issues will go unaddressed.
off-hand some of these characterized as "feasibility studies."
Then these SCT ends up at NEJM and likes ! !
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