RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:A 3rd CR at 450 days?Would the FDA go along with this?
There are FDA procedures in place for dealing with reasonable changes in the clinical protocol during the course of a trial. But I haven't found anything from the FDA which would allow for the exclusion of some trial subjects because of improper dosing or because the clinical protocol was defective or was too vague to be applied properly as Theralase has claimed.
I think this is dangerous territory. It might be wiser not to draw the FDAs attention to this problem in case they decide that given the fact that the trial was improperly conducted they can no longer be confident that it is in patients best interests for it to continue.
It seems to me that the best thing might be to just wait for the ever-growing number of good results to overcome the incorrect dosing of the first 12. Just my opinion. There may be some on the bullboard with a better understanding of the FDA who could set me straight.
"2. Changes to the Clinical Protocol
A Notice of IDE Change may be submitted for changes to the clinical protocol that do not affect: a) the validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol; b) the scientific soundness of the investigational plan; or c) the rights, safety, or welfare of the human subjects involved in the investigation. A notice for a protocol change should include: 1) a description of the change (cross-referenced to the appropriate sections of the original protocol); 2) an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis; and 3) a summary of the information that served as the credible information supporting the sponsor’s determination that the change does not affect the rights, safety or welfare of the subjects.
According to the IDE Modification regulation (§ 812.35(a)(3)(iii)(B)), credible information to support changes to the clinical protocol is defined as the sponsor’s documentation supporting the conclusion that a change does not have a significant impact on the study design or planned statistical analysis, and that the change does not affect the rights, safety, or welfare of the subjects. Documentation may include information such as peer reviewed published literature, the recommendations of the clinical investigator(s), and/or the data generated during the clinical trial or marketing. As previously stated, FDA would also consider IRB approval or concurrence of the DSMB to serve as credible information to support the protocol change."
CancerSlayer wrote: .......................................
Better to simply focus on optimized treatments moving forward, considering all of the first 12 patients received an under-treatment for their primary treatment, & only 5 of the 12 received an optimized 2nd treatment. Imo, that immediately excludes 7 from the "meaningful" data category...& who knows where the other 5 that currently stand. This subset could easily account for any bumps in the "no response" category. It's all about those 3 pending....for me, it'll be another major buy signal if at least 2/3 are CR. Good luck...