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Re: ou71764 post# 5005

Thursday, 02/27/2014 5:45:59 PM

Thursday, February 27, 2014 5:45:59 PM

Post# of 701695
NWBO -- the sponsor in this case (Think fire walled off Marnix Bosch) -- has limited but significant discretion to accept or stay a DMC recommended halt for efficacy. I'm not saying this is happening, I'm saying that there is a reason there are ethicists, independent statisticians, open review exchanges on limited matters, independent/firewalled committees, etc.
(I'm not talking about the individual clinicians, I'm talking about the trial sponsor)

"In almost all cases, a DMC is advisory to the sponsor; the sponsor decides whether to accept recommendations to discontinue a trial. FDA will rarely, if ever, tell a sponsor which decision to make. For trials that may be terminated early because a substantial benefit has been observed, however, consideration may still need to be given to the adequacy of data with regard to other issues such as safety, duration of benefit, outcomes in important subgroups and important secondary endpoints. We recommend that sponsors of trials that could potentially be terminated early for efficacy reasons discuss these issues with FDA prior to implementing the trial, when the statistical monitoring plan and early stopping boundaries are being developed. In these settings, consultation with FDA may provide the sponsor with important information regarding the regulatory and scientific implications of a decision and may lead to better decisions. Sponsors are encouraged to revisit these issues with FDA when considering DMC recommendations for early termination if new issues have arisen and/or if the regulatory implications of early termination were not adequately clarified at the outset of the trial."

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