MisterBlues schreef op 18 september 2020 13:44:
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DMC blijkt toch vrij onbeduidend te zijn...
Bert Jan:
Something I dont't understand from the Politico article: ''Javitt — who is also vice chairman of the board of directors at Relief Therapeutics, which holds the patent on aviptadil — told POLITICO that he selected Harris for the data committee because of the congressman’s experience in critical care settings. Javitt also said that the FDA signed off on the trial knowing that Harris would be involved with the committee.''
It says that Javitt has selected Harris in the DMC. Isn't the DMC supposed to be independent? How can a committee be independent if the CEO of the company gets to choose the members of the committee?
Bert-Jan Yes they have to approve. you can read more here:
www.fda.gov/media/75398/download"DMCs are rarely, if ever, entirely independent of the
sponsor, as the sponsor generally selects the members, gives the committee its charge, and pays
committee members for their expenses and services. Aside from being compensated for their
duties as DMC members, however, we recommend that these members generally have no
ongoing financial relationship with a trial’s commercial sponsor and not be involved in the
conduct of the trial in any role other than that of a DMC member."