November 28, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: clinicaltrials.gov

3 min read

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws, including potentially …Read More

4 min read

It’s hard to even imagine the world of investigative medicine without the wonderful resource of Clinicaltrials.gov, the global hub for clinical trial listings. I recently interviewed the Director of Clinicaltrials.gov, Dr. Deborah Zarin here, which is a fascinating read. As great as Clinicaltrials.gov is as a resource, unfortunately it faces a new, rapidly growing problem that is a serious threat to the site. The Clinicaltrials.gov database is including a rapidly increasing number of for-profit clinical trials that are not by any stretch of the imagination traditional clinical trials. At present, …Read More

8 min read

This post is the first in a series about the Clinicaltrials.gov website. This piece is an interview the Director, Dr. Deborah Zarin. I want to thank her for taking the time to answer my questions. Later, I will post Part 2 in which I discuss my concerns about the trend of for-profit stem cell clinic trials being listed on Clinicaltrials.gov that in my view are not conventional trials. First a little background on Clinicaltrials.gov (see my various posts over the years on it here) before …Read More

6 min read

Last week I wrote a long post detailing the troubling multimillion-dollar reverberations between the Duke autism program and a for-profit stem cell clinic in Panama called The Stem Cell Institute. The potential entanglements between the Duke group and the Panama clinic raise a bunch of questions and concerns. They center on questionable, unproven autism “treatments”. In Duke’s case, their own clinical trial showed there was no benefit, but they forging ahead anyway. Muddy waters This Duke-stem cell clinic situation is a prime example of …Read More