I've read that some believe that Phase 1 Trials are the easiest to run. I beg to differ. In the case of the cream, all in the trial were healthy patients, they had nothing whatsoever to gain at least healthwise from the trial. They were subjected to putting the cream on routinely, taking blood tests multiple times a week. I don't know what they may have paid the healthy patients, but clearly they had some drop outs who didn't think it was worth it.
Now we don't know how the other Phase 1's are being run, but if they have patients who have disease, they may be able to see some benefits. The problem with Phase 1 is that the dosage always starts low and escalates. In general the patients in the first few cohorts see no benefits, but as dosage increases, hopefully the benefits do as well until some sort of maximum benefit is achieved and the maximum tolerated dose is determined. In some cases, if the patients with the lower doses are still eligible, they may receive the higher dose. I'm speaking generally about cancer trials where people are dying, but somewhat the same is true here. When the dose that's determined to be most effective is determined, that's the dose that normally goes to Phase 2 or the Phase 2 portion of a Phase 1/2.
I frankly believe that Phase 2 Trials are easier to run than Phase 1 as there all the patients have the disease and can benefit from whatever is being tested. They are still relatively small trials, not that expensive to run, and they don't have the delays inherent in the safety trial where one cohort cannot begin until the prior cohort is judged to be safe after a specified period of time. Phase 2's can be blinded and run with control groups, or they can all be on the experimental drug, the trial design is up to those running the trial, as well the IRB and perhaps the FDA or similar authority. If the drug used in the trial is of Pivotal quality, it's actually possible to gain approval from such a trial if efficacy is so clear that even a blind man would see it.
To my knowledge, when OWCP says their drugs are "Market Ready" they're saying they're already commercial quality, essentially mass produced pivotal quality material. I believe that everything they're using in trials could be used to build a case for approval, the key is the results must be good enough.
No one should get too excited about what I'm saying as these trials are purely being done under Israeli authority. I have no idea if an approval there will acknowledged by anyone outside of Israel, especially if no other countries are involved in the trials.
Gary
Now we don't know how the other Phase 1's are being run, but if they have patients who have disease, they may be able to see some benefits. The problem with Phase 1 is that the dosage always starts low and escalates. In general the patients in the first few cohorts see no benefits, but as dosage increases, hopefully the benefits do as well until some sort of maximum benefit is achieved and the maximum tolerated dose is determined. In some cases, if the patients with the lower doses are still eligible, they may receive the higher dose. I'm speaking generally about cancer trials where people are dying, but somewhat the same is true here. When the dose that's determined to be most effective is determined, that's the dose that normally goes to Phase 2 or the Phase 2 portion of a Phase 1/2.
I frankly believe that Phase 2 Trials are easier to run than Phase 1 as there all the patients have the disease and can benefit from whatever is being tested. They are still relatively small trials, not that expensive to run, and they don't have the delays inherent in the safety trial where one cohort cannot begin until the prior cohort is judged to be safe after a specified period of time. Phase 2's can be blinded and run with control groups, or they can all be on the experimental drug, the trial design is up to those running the trial, as well the IRB and perhaps the FDA or similar authority. If the drug used in the trial is of Pivotal quality, it's actually possible to gain approval from such a trial if efficacy is so clear that even a blind man would see it.
To my knowledge, when OWCP says their drugs are "Market Ready" they're saying they're already commercial quality, essentially mass produced pivotal quality material. I believe that everything they're using in trials could be used to build a case for approval, the key is the results must be good enough.
No one should get too excited about what I'm saying as these trials are purely being done under Israeli authority. I have no idea if an approval there will acknowledged by anyone outside of Israel, especially if no other countries are involved in the trials.
Gary
