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patrickburke
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http://news.bbc.co.uk/today/hi/today/newsid_7675000/7675335.stm

Even the experts know that its time for change.

jrfoutin
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Interesting that the cost of the dominantly accepted study is identified in the dialog, even though scurried off as "another issue."

Still, the facade endpoints established by "do we have it right" discussions by the FDA have crept into study outcomes there, too, and I believe it was also discussed at the 2006 NORD conference.

Thank you for the link--Janet 

Prof Trevor Marshall
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Janet,
I think the cost being referred to is some limit on the maximum amount of medicine per person per year which is used as a guideline in the UK. I don't think it refers to study costs:)
 
Maybe somebody can clarify this for us...
 

patrickburke
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 Sir Micheal Rawlins,

"I think we spend too much attention on randomised controlled trials and we are not looking enough at observational trials"

 "In the real world the sort of randomised controlled trial we are very used to are not at all good at picking up safety problems"

"I think that this approach (observational) should be used more widely"

"I think sometimes it would mean that drugs were perhaps put on the market earlier than they would have been otherwise"

Prof Trevor Marshall
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Patrick,
Actually his suggestion of a historical comparator is far more significant, for that is exactly what we did - we said that our comparison group was those patients (in the real world) not on the MP. That is a 'historical comparator', and is one of the most ethical, yet controversial, ways of conducting studies in serious diseases.
 

jrfoutin
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If I remember correctly (should check back maybe), I think it was mentioned and then dismissed as another issue. But cost of study types -- as well as more than one type of study -- per indication seems to have some sway on what might be put forth as reliable data so discussions like this one on the BBC are significant to note. 

I'm just glad that observational studies (and other types) are identified in the FDA critical path and that the UK is also identifying observational studies as important.

The Autoimmunity Research Foundation's work with regards to observational studies and the Web must certainly be a significant cornerstone example of ethical process, as well as reliable. Even if scientists aren't up on the impact of what the ARF has done with the Pathogenesis and Protocol, the Process and Platform have great historical significance.



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