imtesty - While reading the article about blinding or open label with regard to vaccines I wondered whether time to response would be a factor in making the decision. In a crossover design the second dose would be 3 weeks for Pfizer and 4 weeks for Moderna for which they are talking about getting a few more weeks of reduced bias. If my understanding is close, out of the 6 months or so of stronger data unbiased results they would only gain a couple of weeks unbiased opinion while the ethical issues of having participants protected or not becomes a bigger factor as each day passes.

'My next comments will be based on what DM said in the 6 Feb webcast and in the QR77 radio interview as the trial design details are not out just yet. From the webcast patients would only be dosed for up to 30 days with ABL and from the radio interview there may be such a positive response that patients may be able to leave the hospital within just a few days of being on ABL. My thought then went to time to response and would it even matter whether the trial is open label or blinded in any way. Would there be enough time within 48 or 72 hours for a bias in one direction or another to even be formed? With that in mind I concluded that if the potential response in this P2 trial is expected to be as rapid as it could be then blinding or open label should not have any significant impact on the outcome.

In any P3 trial that may take place that may be over a longer period of time then there may be greater need to reduce potential biases. The bigger questions on trial designs will come around ethical issues if the desired results are received in the P2 trial. In the Cell report from the Australian trial the cytokine storm was eliminated in 100% of the dosed mice in the study. If ABL has a similar effect in humans then the ethical questions in trial design become exceptionally relevant.

tada