Sunday, July 31, 2022 5:16:10 PM
EDITED
Quote:
I worked in biopharma world for over 20 years including on the team that developed and launched the most successful drug in history (at that time).
I highly doubt this statement obviously you are not the only one who worked in biopharma I'm a PharmD graduate and got the highest scores in different exams in this field I've been involved in different areas of this field in Private, governmental, and as a researcher. I've supervised a few RCTs in different clinical settings and clearly, you have no idea about what you talking about. Regarding your working in your drug discovery either you are a technician or a lab specialist with no knowledge in the clinical settings nor involved with executives. I've improved, supervised, and launched many products in the market due, to my higher education and expertise in drug delivery, especially biologics. With all due respect, you are a guy who tries to give us vague useless background to justify his reasoning.
Just one more thing if you don't believe there's an unblinded pharmacist that can identify who got what. check this document from FDA.
Quote:
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products" rel="nofollow" target="_blank" >https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products[tag]Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
[/tag]
And I quote from the document:
Quote:
FDA does not require patient-level maintenance of blinding at the time of disease
recurrence or progression. Unless there are no available appropriate treatment
alternatives, FDA recommends unblinding only the patient and the investigator at the
time of documented disease recurrence or progression by an objective measurement or
measurements to ensure optimal patient management. If sponsors intend to maintain
patient-level blinding when disease recurs or progresses and there are existing available
treatments, the informed consent document should acknowledge the risks of this
approach, and the protocol should include justification for the potential added risk.
I hope you understand PATIENT-LEVEL Who does identify them? because they don't unblind the whole sample.
EDITED hope this one don't get deleted
Quote:
I worked in biopharma world for over 20 years including on the team that developed and launched the most successful drug in history (at that time).
I highly doubt this statement obviously you are not the only one who worked in biopharma I'm a PharmD graduate and got the highest scores in different exams in this field I've been involved in different areas of this field in Private, governmental, and as a researcher. I've supervised a few RCTs in different clinical settings and clearly, you have no idea about what you talking about. Regarding your working in your drug discovery either you are a technician or a lab specialist with no knowledge in the clinical settings nor involved with executives. I've improved, supervised, and launched many products in the market due, to my higher education and expertise in drug delivery, especially biologics. With all due respect, you are a guy who tries to give us vague useless background to justify his reasoning.
Just one more thing if you don't believe there's an unblinded pharmacist that can identify who got what. check this document from FDA.
Quote:
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products" rel="nofollow" target="_blank" >https://www.fda.gov/regulatory-information/search-fda-guidance-documents/placebos-and-blinding-randomized-controlled-cancer-clinical-trials-drug-and-biological-products[tag]Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
[/tag]
And I quote from the document:
Quote:
FDA does not require patient-level maintenance of blinding at the time of disease
recurrence or progression. Unless there are no available appropriate treatment
alternatives, FDA recommends unblinding only the patient and the investigator at the
time of documented disease recurrence or progression by an objective measurement or
measurements to ensure optimal patient management. If sponsors intend to maintain
patient-level blinding when disease recurs or progresses and there are existing available
treatments, the informed consent document should acknowledge the risks of this
approach, and the protocol should include justification for the potential added risk.
I hope you understand PATIENT-LEVEL Who does identify them? because they don't unblind the whole sample.
EDITED hope this one don't get deleted
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