RAC - Charts & Price Action, page-25358

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    We had extensive consultation with clinicians in the design of the EMD AML trial and all the clinicians were happy with the design. Where the breakdown happened is over what the clinicians said at the time of the design of the trial and what they did in practice. This unfortunately happens quite often in clinical trials with innovative designs and there really is nothing you can do about this other than recognise it has happened and adjust the trial to overcome the problem. This we what we did with the EMD AML trial.

    With the current trial things are far simpler as there is no need to do something that is not standard of care to allow the patients to enter the trial. The screening criteria are totally standard for a Phase 1 oncology trial.


 
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