Yooper61 posted the following on another board. S
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Posted On: 02/18/2018 1:42:31 PM
Yooper61 posted the following on another board. Sure sounds supportive of belief that results for P2b should be pretty good.
The FUDster position that P is likely to fail based on no interim report is flawed. Since mgmt gets the Case Report Forms (CRFs), they know the overall results (source below). If in fact, the drug had no effect at 6 weeks, you cannot then say, therefor it is not likely to be effective at 12 weeks. Try applying that logic to Otezla, studied over a 16 week trial. Was it discernable from blinded data, that Otezla was effective at 6 weeks?
When mgmt was assessing the 6 week data, they had 12 week data at hand also, with 70% enrolled. The expected placebo PASI-75 rate is 5.5% (at 16 weeks). If blinded overall 12-week PASI-75 rate was not above this by whatever cushion they required, Leo would have shut the trial down. If the 12-week rate was really good, but 6 week not obivious, then they don’t need to break the blind, and they maintain greater statistical integrity of the trial. If 12-week was in the gray, undeterminable area, they would have broken the blind to see how the drug was doing at 6 & 12 weeks. And what did they do??? They cancelled the interim, and twice added trial sites, spending $3.3M over the next 6 months. Hmmmmm. And every PR and public comment since last June regarding P has been upbeat.
A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[1] Site personnel capture the subject's data on the CRF, which is collected during their participation in a clinical trial. The International Conference on Harmonization Guidelines for Good Clinical Practice define the CRF as: A printed, optical or electronic document designed to record all of the protocol – required information to be reported to the sponsor on each trial subject.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/
A CRF is of high importance in clinical research, we can even call it the backbone of a research because it houses all information regarding the patient participating in a particular study. It is used by the sponsor of the clinical trial to collect data from each patient who is participating. It houses all information gathered from the patient that includes his case history too. Thus all data from each participating patient is collected and filed in a CRF and is kept to be used for consideration and future reference during the study. All data obtained about the patient during the clinical trial are recorded in the CRF but are de-identified by replacing the patients name and by giving him a unique number before being sent to the sponsor of the study.
http://blog.sollers.edu/clinical-research/cas...l-research
ICH Guidance E6: Good Clinical Practice: Consolidated guideline. US HHS, US FDA, CDER, CBER.1996. [Last accessed on 2013 Jun 11].
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf .
The FUDster position that P is likely to fail based on no interim report is flawed. Since mgmt gets the Case Report Forms (CRFs), they know the overall results (source below). If in fact, the drug had no effect at 6 weeks, you cannot then say, therefor it is not likely to be effective at 12 weeks. Try applying that logic to Otezla, studied over a 16 week trial. Was it discernable from blinded data, that Otezla was effective at 6 weeks?
When mgmt was assessing the 6 week data, they had 12 week data at hand also, with 70% enrolled. The expected placebo PASI-75 rate is 5.5% (at 16 weeks). If blinded overall 12-week PASI-75 rate was not above this by whatever cushion they required, Leo would have shut the trial down. If the 12-week rate was really good, but 6 week not obivious, then they don’t need to break the blind, and they maintain greater statistical integrity of the trial. If 12-week was in the gray, undeterminable area, they would have broken the blind to see how the drug was doing at 6 & 12 weeks. And what did they do??? They cancelled the interim, and twice added trial sites, spending $3.3M over the next 6 months. Hmmmmm. And every PR and public comment since last June regarding P has been upbeat.
A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[1] Site personnel capture the subject's data on the CRF, which is collected during their participation in a clinical trial. The International Conference on Harmonization Guidelines for Good Clinical Practice define the CRF as: A printed, optical or electronic document designed to record all of the protocol – required information to be reported to the sponsor on each trial subject.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170533/
A CRF is of high importance in clinical research, we can even call it the backbone of a research because it houses all information regarding the patient participating in a particular study. It is used by the sponsor of the clinical trial to collect data from each patient who is participating. It houses all information gathered from the patient that includes his case history too. Thus all data from each participating patient is collected and filed in a CRF and is kept to be used for consideration and future reference during the study. All data obtained about the patient during the clinical trial are recorded in the CRF but are de-identified by replacing the patients name and by giving him a unique number before being sent to the sponsor of the study.
http://blog.sollers.edu/clinical-research/cas...l-research
ICH Guidance E6: Good Clinical Practice: Consolidated guideline. US HHS, US FDA, CDER, CBER.1996. [Last accessed on 2013 Jun 11].
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf .
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