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Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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July 17, 2013

More on the NIH and Its Indian Clinical Trials

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Posted by Derek

Steve Usdin of BioCentury sends along word that they've managed to get a tiny bit more out of the NIH on the Indian clinical trials business. As opposed to the happy-talk that they gave FiercePharma the day before, the agency was now willing to confirm that enrollment has been stopped in some Indian trials, while others have been postponed. No numbers, though. They said that they hoped that "future changes will enable studies to resume", which is a bit of a telling statement in itself, suggesting that the current situation will not allow that at all.

The most detailed account of the situation remains the report in the Live Mint newspaper, an Indian source affiliated with the Wall Street Journal. That article mentions the "unstable regulatory environment" as the big factor, but according to BioCentury, this might be the biggest problem:

The new regulations require clinical trial sponsors to provide compensation to patients who suffer injury or death during or as a result of the trial, including as a result of the "failure of investigational product to provide intended therapeutic effect"

Oh, boy. If companies find themselves having to compensate everyone - in unspecified amounts - that joins a Phase II trial where the compound turns out not to work, that'll mount up fast. We have high failure rates around here, as everyone knows, and everyone involved (investors, patients, clinical trial participants) should be aware of that going in and act accordingly. I believe that both companies and granting agencies feel as if they're paying quite enough money already for the way that many drugs don't work in the clinic.

Comments (3) + TrackBacks (0) | Category: Clinical Trials | Regulatory Affairs


1. Zach on July 17, 2013 8:01 AM writes...

I'm confused as to why this is re-surfacing now. The compensation guidelines and subsequent anger surfaced well over a year ago. The Parliamentary report from last summer was significantly more damning of the DCGI and CDSCO...but talk to any clinical trial expert and they could care less about what's going on India. The country has never seen more than 5% of the world's trials and that's been falling for the last two years. And as to the NIH's non-response: Try asking any government agency a specific question and see what the response is. Why would they provide numbers?

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2. bigbnc on July 22, 2013 1:34 PM writes...

Question for the CRO community is whether or not their Indian-based clinical investigator sites will continue as is or if the big guys like Q and PPD will follow suit with NIH and wave goodbye to India all together...

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3. Holy Joe on July 29, 2013 9:00 AM writes...

This does make sense.

The new regulations require clinical trial sponsors to provide compensation to patients who suffer INJURY or DEATH during or as a result of the trial, including as a result of the "failure of investigational product to provide intended therapeutic effect"

This does make sense.

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