Farmer,
I don't believe that what you're suggesting is completely legal, but that's not to say it's impossible. I believe that such funding has to be reported as a material event very shortly after it occurs, not something that can be put off to the quarterly report.
I wouldn't be at all surprised if such funding is pending safety results with the cream, and can be announced as soon as safety is assured in the Phase 1 Trial. The company could know it will happen, but the completion of the Phase 1 Trial is dependent on the clinicians.
I believe much of the problem in such trials is anticipating how many will drop out, if too few are anticipated, new people have to be started when most are nearly finished. The trial is structured to evaluate a specific number of patients, if even one less than that finish, but all others drop out, someone new must be added and go through the entire process. The safety trial was done with healthy patients, they had nothing to gain healthwise for being in it. I don't know what compensation they may have been given, but it involved a lot of time, and many blood draws, it doesn't surprise me that more than anticipated drop t out has extended the duration of the trial. I would hope that future trials are done with patients who have medical conditions where they have something to gain by being in the trial. In that the trials are probably blinded and have one third getting placebo's, some may drop out in seeing no improvement themselves. I believe that in many trials, those getting placebos may be permitted to go on the trial drug after they've been through the required testing and their personal results have been established.
It's my personal belief that trials shouldn't be run this way. I believe that historical data should be sufficient for comparison purposes, and all volunteering for a trial should get the trial drug. Before the trial is ever initiated, the historical data should set a mark which needs to be exceeded to call the trial a success, at least from an efficacy standpoint. If the trial fails to exceed that mark, but it's determined that side effects are an improvement on the SOC, the drug developer should be able to go for an approval based on quality of life issues. The biggest problem for drug makers is trial costs, once they fail in trials done in one way, they rarely have the funding needed to do it again in a different way.
The new head of the U.S. FDA has actually proposed changing the way trial are done, allowing for changes in the protocol as more is learned about the drug. I certainly hope he is successful as I believe that this will not only greatly lower the cost of doing trials, but also result in far more approvals. In the past, DLT was called in escalating trials because patients needed something as simple as eye drops or headache meds to escalate to higher doses, which may have been far more effective, the FDA attitude had been, just run another trial and make that part of the protocol. The FDA never cared how much money the drug maker was forced to spend to do things their way. If the new head actually makes a change, it will be a big step in the right direction, but he is fighting an organization that's very entrenched in it's way of doing things.
Gary
I don't believe that what you're suggesting is completely legal, but that's not to say it's impossible. I believe that such funding has to be reported as a material event very shortly after it occurs, not something that can be put off to the quarterly report.
I wouldn't be at all surprised if such funding is pending safety results with the cream, and can be announced as soon as safety is assured in the Phase 1 Trial. The company could know it will happen, but the completion of the Phase 1 Trial is dependent on the clinicians.
I believe much of the problem in such trials is anticipating how many will drop out, if too few are anticipated, new people have to be started when most are nearly finished. The trial is structured to evaluate a specific number of patients, if even one less than that finish, but all others drop out, someone new must be added and go through the entire process. The safety trial was done with healthy patients, they had nothing to gain healthwise for being in it. I don't know what compensation they may have been given, but it involved a lot of time, and many blood draws, it doesn't surprise me that more than anticipated drop t out has extended the duration of the trial. I would hope that future trials are done with patients who have medical conditions where they have something to gain by being in the trial. In that the trials are probably blinded and have one third getting placebo's, some may drop out in seeing no improvement themselves. I believe that in many trials, those getting placebos may be permitted to go on the trial drug after they've been through the required testing and their personal results have been established.
It's my personal belief that trials shouldn't be run this way. I believe that historical data should be sufficient for comparison purposes, and all volunteering for a trial should get the trial drug. Before the trial is ever initiated, the historical data should set a mark which needs to be exceeded to call the trial a success, at least from an efficacy standpoint. If the trial fails to exceed that mark, but it's determined that side effects are an improvement on the SOC, the drug developer should be able to go for an approval based on quality of life issues. The biggest problem for drug makers is trial costs, once they fail in trials done in one way, they rarely have the funding needed to do it again in a different way.
The new head of the U.S. FDA has actually proposed changing the way trial are done, allowing for changes in the protocol as more is learned about the drug. I certainly hope he is successful as I believe that this will not only greatly lower the cost of doing trials, but also result in far more approvals. In the past, DLT was called in escalating trials because patients needed something as simple as eye drops or headache meds to escalate to higher doses, which may have been far more effective, the FDA attitude had been, just run another trial and make that part of the protocol. The FDA never cared how much money the drug maker was forced to spend to do things their way. If the new head actually makes a change, it will be a big step in the right direction, but he is fighting an organization that's very entrenched in it's way of doing things.
Gary
