Next week we're into another new month. If the sa
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Posted On: 04/29/2018 2:08:01 AM
Next week we're into another new month. If the safety trial isn't revealed shortly I've got to believe that we've once again had drop outs requiring getting more people into the trial. To me it's sad that clinical trials are so cut and dried that when you say the trial is for 30 people, and 29 are finished, but all others have dropped out, you need to add one or more people to the trial and continue it until number 30 has finished.
It's my belief that the IRB should have the flexibility to modify the trial if they are convinced the results are solid prior to the last patient to finish the protocol. In Phase 1 Trials it's normally a small number, but Phase 3 Trials often run into hundreds and even thousands, and while their are typically built in peeks, at least for futility, if the clinicians at every site working on the trial believed the outcome was quite positive, it would cut costs and save time if they could recommend the FDA unblind result early, at least to them. It would really be great if the FDA reviewed the unblinded data and decided to approve the drug without a major effort to present the data in a BLA or DNA as applicable. Eight or so months could probably be saved, allowing two months for preparation, and six months for the FDA reviewing the application for approval. More importantly, if the drug is for a deadly disease, how many might be saved if 8 months or more was saved in the process.
Gary
It's my belief that the IRB should have the flexibility to modify the trial if they are convinced the results are solid prior to the last patient to finish the protocol. In Phase 1 Trials it's normally a small number, but Phase 3 Trials often run into hundreds and even thousands, and while their are typically built in peeks, at least for futility, if the clinicians at every site working on the trial believed the outcome was quite positive, it would cut costs and save time if they could recommend the FDA unblind result early, at least to them. It would really be great if the FDA reviewed the unblinded data and decided to approve the drug without a major effort to present the data in a BLA or DNA as applicable. Eight or so months could probably be saved, allowing two months for preparation, and six months for the FDA reviewing the application for approval. More importantly, if the drug is for a deadly disease, how many might be saved if 8 months or more was saved in the process.
Gary
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