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Welcome to MoreTrials.

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Presentation on theme: "Welcome to MoreTrials."— Presentation transcript:

1 Welcome to MoreTrials

2 Randomised trials are the most reliable method to test the effects of health interventions…….

3 ……. this is so well accepted in medicine that it has become something of a cliché.

4 Randomised trials were invented just over 60 years ago……

5 ……this might well be one of the most important scientific discoveries of the 20th century.

6 This discovery was made in medicine, but because of their unique value randomised trials are today widely applied across many areas of life.

7 The last 20 years has seen the explosion of randomised trials done in these other areas, but in medicine things have gone backwards……

8 ……with trials becoming much more complex, difficult to do and way too costly.

9 This is the result of bad regulation of trials and one regulation in particular, the ICH Guideline (E6) on Good Clinical Practice (ICH-GCP).

10 ICH-GCP has two fundamental problems…..

11 1) it focuses on operational detail rather than high-level principles

12 2) the high-level principles that it does set out are not the key principles to do a randomised trial well.

13 This has happened because experts at doing randomised trials were not involved in writing ICH-GCP.

14 The solution is simple and obvious…..

15 …..Bring together experts at doing randomised trials to write a new guideline based upon the key scientific principles to do a trial well and develop it with everybody in the trial community.

16 MoreTrials has brought together over 230 experts at doing randomised trials from around 30 countries to develop a new guideline to do trials well Join us


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