I thought that clean patients enabled the evaluation of efficacy.
And that the role of effectiveness studies was to test efficacious interventions in patients and clinical systems representative of the real world.
Jim
James M. Walker, MD, FACP
Chief Medical Information Officer
Geisinger Health System
The best way to predict the future is to invent it.
- Alan Kay
>>> Paul Elias 07/12/12 9:29 AM >>>
Some argue that the use of perfect or 'clean' patients in a trial makes it a faster, cheaper design, and allows them to see side effects more clearly....
well it makes some sense no doubt but does this not limit external validity (generalizability) and make it difficult to expand findings to the general population? maybe one route is to ensure more stronger and longer term post market surveillance??
Best,
Paul E. Alexander
--- On Thu, 7/12/12, Ash Paul wrote:
From: Ash Paul
Subject: Re: Choice of inappropriate comparator...
To: [log in to unmask]
Received: Thursday, July 12, 2012, 11:54 AM
Dear Ben, Sometimes I really seriously wonder whether the industry lives in 'zombie' land or not! In the non-internet age, it might have been possible to fool others and get away with talking b--l s--t, but not any longer, with the world-wide web serving as one's loyal and instant servant, if one know how to operate and command it appropriately, that is! Mastery of the world-wide web should be an integral part of the curriculum of both current undergrad and post-grad medical schools, is my opinion, for whatever tuppence it's worth! UK's NICE recently gave GSK's Benylta a right royal walloping with regards to their choice of inappropriate
comparator.So did Germany's IQWiG when it declared 'Benylta offers no additional benefits over oprimised standard therapy'.IQWiG also slapped down Biogen's Fampyra for using inappropriate comparators and dismissed it as 'showing no additional benefit over physiotherapy amongst patients with walking disability'. There was a very good write up on this subject recently in the Real EndPoints Blog:'Get the Right Comparator', Scream Euro Gatekeepershttp://realendpoints.com/2012/05/get-the-right-comparator-scream-euro-gatekeepers/ Ben Goldacre wrote a very good article on this topic, in
his 'Bad Science' Blog in May 2011:Asking the Wrong question: How Cr-p Research Gets Drugs to Markets'http://www.badscience.net/2011/05/asking-the-wrong-question-how-crap-research-gets-drugs-to-market/In his article, he refers to a 2011 JAMA article 'Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States':http://jama.jamanetwork.com/article.aspx?articleid=899516 Regards, Ash
From: "Djulbegovic, Benjamin"
To: [log in to unmask]
Sent: Wednesday, 11 July 2012, 12:03
Subject: choice of inappropriate comparator...
Dear colleagues,
In 2004 we published the paper on comparator bias - documenting how the choice of inappropriate comparator can lead to the results in predictable direction ( see
http://www.jameslindlibrary.org/essays/bias/comparator-bias.html)
Recently, however, some folks - particularly from industry- claim that this is not happening any more, and that regulators now protect public by determining the most appropriate comparator for the sponsor. Most of
believe that this is really not the case, at least in the vast majority of the published trials. Because of this we have been asked to update our article with most recent examples. So, I am writing to tap into your collective knowledge and ask you if you know of any recent ( last 2-3 years) example of the published trial where the comparator was clearly inappropriate to majority of impartial observers ( regardless of funding source ).
We will, of course, be happy to acknowledge your help.
Many thanks
Ben Djulbegovic
USF
Sent from my iPad
( please excuse typos & brevity)
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