I agree it's frustrating, but you need to realize that it's largely out of their control. In the case of the psoriasis cream, they did submit the protocol on the clinical trials database, and it may have been reviewed by the FDA, but I'm not certain of that. The point is, the trial is turned over to the IRB which finalizes the protocol, it's more precise than what is described in the clinical trials database, if it appears there at all. The IRB frequently takes several months to do their thing, but when they're done, it's put into the hands of the clinicians.
While OWCP has a great relationship with the hospital running the trial, they don't dictate to them. Hopefully they can communicate with them about progress, but the trial is blinded and if they're properly following the protocol, little or nothing can be said about results, but I believe they can update them on progress.
Certainly companies can influence the speed in which trials are done by establishing several trial sites, but the cost is higher. OWCP has been doing their work about as cheaply as it can be done and no doubt it has extended the time, but I also think that no one could control the number of drop outs they've apparently had. Remember, these are healthy patients who had to go through a number of blood draws to complete the trial. I don't know what, if any, compensation was given to those who volunteered, but clearly it wasn't so great that people didn't drop out. I would suspect that many may have been employees of Sheba Hospital, but that's just speculation on my part. I think it's sad that the trial couldn't have been done with people who actually had psoriasis, but I believe that was out of the companies control when they initially developed the protocol, it was demanded by either agencies like the FDA, or the IRB.
I'm a strong believer that clinical trials should be streamlined and that all patients in a trial should get the experimental drug, but that's not how it's being done. Almost every trial has roughly one third the participants getting placebo's, and their is little doubt that placebo's do have some positive effects for some conditions, but I still believe if you have substantial historical data, it should be the basis for determining if the experimental treatment is a meaningful improvement. In the case of psoriasis, improvement ought to be judged by improvement in the condition more than bettering the results of other drugs because both costs and potential negative side effects prevent many patients from using the drugs which are taken internally. I believe in many cases, quality of life issues need to be considered as much as curative effects.
Gary
While OWCP has a great relationship with the hospital running the trial, they don't dictate to them. Hopefully they can communicate with them about progress, but the trial is blinded and if they're properly following the protocol, little or nothing can be said about results, but I believe they can update them on progress.
Certainly companies can influence the speed in which trials are done by establishing several trial sites, but the cost is higher. OWCP has been doing their work about as cheaply as it can be done and no doubt it has extended the time, but I also think that no one could control the number of drop outs they've apparently had. Remember, these are healthy patients who had to go through a number of blood draws to complete the trial. I don't know what, if any, compensation was given to those who volunteered, but clearly it wasn't so great that people didn't drop out. I would suspect that many may have been employees of Sheba Hospital, but that's just speculation on my part. I think it's sad that the trial couldn't have been done with people who actually had psoriasis, but I believe that was out of the companies control when they initially developed the protocol, it was demanded by either agencies like the FDA, or the IRB.
I'm a strong believer that clinical trials should be streamlined and that all patients in a trial should get the experimental drug, but that's not how it's being done. Almost every trial has roughly one third the participants getting placebo's, and their is little doubt that placebo's do have some positive effects for some conditions, but I still believe if you have substantial historical data, it should be the basis for determining if the experimental treatment is a meaningful improvement. In the case of psoriasis, improvement ought to be judged by improvement in the condition more than bettering the results of other drugs because both costs and potential negative side effects prevent many patients from using the drugs which are taken internally. I believe in many cases, quality of life issues need to be considered as much as curative effects.
Gary
