Well, here is a guide that I found, that talks about the role of the DSMB.
Note that it specifically highlights confidentiality as the main purpose ( otherwise the company or NIH would just look at the results themselves ).
For that reason, I don't think that any data has been unblinded - which would be a change in the trial design to Blind RCT, in which case clinical trials should have been updated with the modification and FDA notified. The company asked for fast track based of the initial 12 doses Mt Siani, and probably provided the standard supportive text it used for GvHD to justify the inflammation biomarker reduction as a generic result and not a disease specific result of the treatment. Fast track is good as it speeds up the timeline, however it's no a guarantee of anything. That will only come if we get halted at 60%, or the 100% results come out.
Remember GVHD got fast tracked, it met primary end points, it ran to 100%, was voted 9 to 1 by the ODAC and we got no approval at all.
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The DSMB should review each protocol for any major concern prior to implementation. During the trial, the DSMB should review cumulative study data to evaluate safety, study conduct, and scientific validity and integrity of the trial. As part of this responsibility, DSMB members must be satisfied that the timeliness, completeness, and accuracy of the data submitted to them for review are sufficient for evaluation of the safety and welfare of study participants.
The DSMB should also assess the performance of overall study operations and any other relevant issues, as necessary.Items reviewed by the DSMB include:
Interim/cumulative data for evidence of study-related adverse events;
Interim/cumulative data for evidence of efficacy according to pre-established statistical guidelines, if appropriate;
Data quality, completeness, and timeliness;
Performance of individual centers;
Adequacy of compliance with goals for recruitment and retention, including those related to the participation of women and minorities;
Adherence to the protocol;
Factors that might affect the study outcome or compromise the confidentiality of the trial data (such as protocol violations, unmasking, etc.); and,
Factors external to the study such as scientific or therapeutic developments that may impact participant safety or the ethics of the study.
The DSMB should conclude each review with their recommendations to NIDCR as to whether the study should continue without change, be modified, or be terminated. Recommendations regarding modification of the design and conduct of the study could include:
Modifications of the study protocol based upon the review of the safety data;
Suspension or early termination of the study or of one or more study arms because of serious concerns about subjects’ safety, inadequate performance, or rate of enrollment;
Suspension or early termination of the study or of one or more study arms because study objectives have been obtained according to pre-established statistical guidelines;
Optional approaches for investigators to consider when the DSMB determines that the incidence of primary study outcomes is substantially less than expected (such as recommendations to increase the number of trial centers or extend the recruitment period);
and,Corrective actions regarding a study center whose performance appears unsatisfactory or appears to raise questions regarding the conduct of the study.Confidentiality must always be maintained during all phases of DSMB review and deliberations. "
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