Comments for Clinical Research insights from CRfocus

Comment on About CRfocus by Sohan Dhande

Sohan Dhande — Fri, 10 Jul 2009 15:35:58 +0000

Hi,
Great blog.
very useful & informative.

Regards,
sohan.dhande@DGenre.com
http://www.DGenre.com

Comment on ICREL conference (part 1) by EFGCP workshop on a single clinical trial application for pan-national studies « Clinical Research insights from CRfocus

Tue, 07 Jul 2009 14:20:56 +0000

[...] would have preferred to reporting from Brussels on the EFGCP’s latest workshop, building on the ICREL workshop in December 2008 to discuss possible routes towards a single clinical trial application for multinational clinical [...]

Comment on ICR/EMWA symposium by Blogging from the ICR/EMWA joint symposium next week « Clinical Research insights from CRfocus

Fri, 20 Feb 2009 11:14:53 +0000

[...] to publish a full report of the conference in the July issues of CRfocus and The Write Stuff. As I did last year, I will be reporting on some of the sessions direct to this blog, with the other sessions being [...]

Comment on Guidelines in Review by Naomi

Naomi — Thu, 27 Nov 2008 20:28:16 +0000

just happened in….

Not what I was looking for, but great site. Thanks….

Comment on ADVANTAGE study on Vioxx raises questions about “seeding studies” & scientific value by majikthyse

majikthyse — Fri, 29 Aug 2008 13:46:10 +0000

I suppose seeding studies can’t be all bad. To impress the prescriber they should be able to show that the drug works . But this raises wider issues, relating to the involvement of sales and marketing in R & D. This blew up in the early 80s (yes I do remember!), and the ABPI erected a Chinese wall between the two. This has been progressively eroded and in the current ABPI code it’s impossible to find any clear policy on it. Do you think it’s time this was made clear again? My view is that it’s quite hard enough ridding clinical trials of bias, without allowing commercial pressure to make it even worse.

Comment on ADVANTAGE study on Vioxx raises questions about “seeding studies” & scientific value by Andrew Smith

Andrew Smith — Fri, 22 Aug 2008 15:52:35 +0000

A very interesting point. I know of no data on the prevalence of seeding studies, and even the class action route depends on a drug encountering high-profile problems follwing a successful registration and launch. The classification of a study as as seeding study depends on a judgement of the scientific value of the study, which is likely to be time-sensitive and subjective, based on individuals’ differing knowledge of the current state of (published, unpublished and ongoing) literature. I expect virtually all studies would be considered valid and valuable by the professionals conducting them…

Comment on ADVANTAGE study on Vioxx raises questions about “seeding studies” & scientific value by crmidwest

crmidwest — Fri, 22 Aug 2008 14:57:03 +0000

The insights from the article in AIM were illuminating to the serious issue of conflict of interest that is afoot in clinical research. Unfortunately, the article stated that one of the limitations of this study was, “…The use of litigation documents from 1 company provides a useful perspective on the practices of the pharmaceutical industry but may not be generalizable to other companies. We do not know how common these practices are.” It begs the questions, “Can you confirm that ’seeding studies’ are common? Does the data on their incidence and prevalence exist, and can it be obtained apart from having class action lawsuits due to adverse reactions?”

Comment on PPRS: Achievable Compromise or Missed Opportunity? by Bigger = better for late phase clinical trials… but who pays? « Clinical Research insights from CRfocus

Mon, 18 Aug 2008 11:59:00 +0000

[...] which in the current media climate could be perceived as profiteering and fly in the face of the recent agreements between the NHS and ABPI on the future of the Pharmaceutical Pricing Regulation Sc…. The only plausible alternative to this would be to take more drastic cost-cutting measures, [...]