JRIII,
All the things you're saying can't be done can be. They can be done as long as they're done properly. It's clear that NWBO changed the judgement criteria before they locked the trial. We know what the changes are because the European authorities put them in their version of Clinical Trials, it surprised NWBO because they forgot that in Europe the regulators do that, not the trial sponsor, but it's there, anyone can check it out.
It was the regulators who after halting the trial agreed that all should get the vaccine, no further control group. As I understand it the German's insisted on this change as they saw the benefit and wanted no further patients not to receive it, finally the other regulators agreed. Frankly, the regulators should have halted the trial right then and approved the vaccine, but they just aren't that dynamic.
You and others can fault the company all you wish, but I don't believe that you can cite anything that's truly illegal, the rules permit what they've done and sadly the regulators often don't care how much time and money can be spent while they're reviewing a requested change, but at the end of the day, they agreed.
Frankly it saddens me that a company can't change the goals after they've seen the results when the results are telling them there was a better way to judge it. In our case Overall Survival is the most convincing case, why not allow it to become the primary goal. It wasn't hard to see that that should be the case when so many people were living so long, but if they had ignored it, why not permit them to ask the regulators to change the goal even after it's unblinded. They didn't do that, they did it by the book, but what would be the harm in the book being re-written permitting it.
Gary
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