July 11, 2020

The Niche

Knoepfler lab stem cell blog

Deborah Zarin

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 Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws,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

17 min read

When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding …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 before I get into the interview. It is the global clinical trials website …Read More