Actually, it appears there are access paths for the FDA to access DMC data beyond safety. "Urgent concern" might at first sound like a catch-all for safety, but it is clearly delineated in the DMC Guidelines written by the FDA.
7.2.2. IMHO
"In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decision-making."
Section 6.5 provides yet another avenue, IMHO
"Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities…. Where the sponsor nonetheless has a compelling need to review such information, certain approaches may lessen, although they do not eliminate, risks to the trial:
Discussion of such an action with FDA in advance. This is particularly advisable when the sponsor intends to use the study in support of a licensing [Germany?] or marketing application…."
Section 7.2 also might necessarily give the FDA access, IMHO
7.2. Accessing Interim Data
"As discussed above, accessing interim data by the sponsor carries many risks, not all of which may be fully appreciated by the sponsor. We recommend that sponsors contact FDA before initiating communication with the DMC regarding access to interim data from a trial likely to be an important part of a regulatory submission. While FDA permission is not required, a discussion regarding the potential risks and implications of that action and of methods to limit the risks may contribute to informed decision making."
7.2.1 Terminating for efficacy also may give the FDA significant inroads to interim info, IMHO
"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….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."
