While I believe it should finish as scheduled, the
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Posted On: 06/07/2018 3:37:44 PM
While I believe it should finish as scheduled, the problem in such a trial can be just one single patient dropping out, when that is the last patient required to complete the trial. As I remember it, the trial has a 60 day evaluation period, if someone dropped out 30 days before they were to complete, even if someone could be found that very day to start, it would take 30 additional days.
Clearly it would be best to have a few extra people in the trial to account for drop outs, but remember, people in this trial are healthy, they see no health benefit from being in the trial. I don't know what compensation they may receive, but I think it's clear that the compensation hasn't been great enough to not have drop outs, and from the delays, I suspect the number who've dropped out is substantial.
Frankly, it gets better with patients who could have benefits, but even there it's questionable because not all patients get the drug, some, usually one third, will get a placebo cream, and it's very possible that patients seeing no benefit will drop out. To complete a trial, the specified number must finish.
If it were up to me, I'd ignore the placebo effect and allow all in the trial to use the drug and look at the benefits. I frankly don't think it's fair to people who volunteer not to get some benefit, or at least the potential of some benefit, but the FDA and other agencies don't view it that way. To me it's even worse with terminal diseases where historic outcome is well known, but still you must have a control group, rather than accepting existing data as the baseline to be improved upon.
I'm frankly still uncertain what the plan is for other scheduled Phase 1 Trials, I.E. are they being run with healthy patients, or with patients who have the condition the drug is intended to work on. Like so much else, the company has not published the protocol in clinical trials, or other database that shows what they're doing, or where they're doing it. By not posting what they're doing, people with the condition can't find the trial and it's up to the clinicians to recruit patients for the trial, to me, this lengthens the time needed to run the trial.
Gary
Clearly it would be best to have a few extra people in the trial to account for drop outs, but remember, people in this trial are healthy, they see no health benefit from being in the trial. I don't know what compensation they may receive, but I think it's clear that the compensation hasn't been great enough to not have drop outs, and from the delays, I suspect the number who've dropped out is substantial.
Frankly, it gets better with patients who could have benefits, but even there it's questionable because not all patients get the drug, some, usually one third, will get a placebo cream, and it's very possible that patients seeing no benefit will drop out. To complete a trial, the specified number must finish.
If it were up to me, I'd ignore the placebo effect and allow all in the trial to use the drug and look at the benefits. I frankly don't think it's fair to people who volunteer not to get some benefit, or at least the potential of some benefit, but the FDA and other agencies don't view it that way. To me it's even worse with terminal diseases where historic outcome is well known, but still you must have a control group, rather than accepting existing data as the baseline to be improved upon.
I'm frankly still uncertain what the plan is for other scheduled Phase 1 Trials, I.E. are they being run with healthy patients, or with patients who have the condition the drug is intended to work on. Like so much else, the company has not published the protocol in clinical trials, or other database that shows what they're doing, or where they're doing it. By not posting what they're doing, people with the condition can't find the trial and it's up to the clinicians to recruit patients for the trial, to me, this lengthens the time needed to run the trial.
Gary
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