Novartis deal on the rocks, page-114

So now you are implying Drs across 4 or 5 sites, probably across different states, are collating all their internal ICU stats as well as sharing data from the Rem-L trial patient outcomes? And somehow, they also know the trial was designed for a massive 43% outperformance which would allow them to think they can make 'educated' guess, thought still statistically invalid, to not recommend Rem-L to their dying patients. I wonder if they did the same for Remdesivir or other failed drug cocktails which have been enrolling at tremendous rates with no or minimal outcomes?

Well, maybe that's why the study was stopped - Dr's moonlighting as statisticians, sharing confidential data in an effort to unmask trial data. A bit like when a jury is dismissed when some jury members start googling the background and previous history of the defendant or start doing their own investigations based on what they have heard in court evidence:

• 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.
  https://www.nidcr.nih.gov/research/human-subjects-research/toolkit-and-education-materials/interventional-studies/data-and-safety-monitoring-board-guidelines#:~:text=The%20primary%20responsibilities%20of%20the,or%20termination%20of%20the%20trial.