Msg below references a direct response from Leo re
Post# of 72440
(Total Views: 230)
Posted On: 09/14/2017 8:52:08 AM
Msg below references a direct response from Leo re: P interim data. IMO it could be taken 2 ways. 1) is that the interim data will be next to nil so that it doesn't create investigator bias and 2) is that the data is already so persuasive that it could call for an early termination and declaration of success. I will hang my hat on #1 so I still expect interim data on P to be pretty light and nebulous as to giving a firm statement of results to date.
If it is #1 I expect it on a Thur or Fri, if #2 more likely early in the week.
Strictly a WAG as to timing of release.
cabel Thursday, 09/14/17 08:36:29 AM
Re: None
Post # of 196732
I sent this artilce to Leo,....
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/
Interim analysis: A rational approach of decision making in clinical trial
He responded yesterday with this and based on his explanation I support him in his decision.
From Leo:
Please note the first paragraph of the article you sent me.
Quote from Abstract
Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.
From Leo:
Our plan was to to do an interim analysis of patients who completed week 6 and look for a signal. Recruitment into the study was slower than anticipated. At this time, as most patients have completed the study, a look could create investigator bias. It will likely effect the Alpha and require more patients to be added to the study.
If it is #1 I expect it on a Thur or Fri, if #2 more likely early in the week.
Strictly a WAG as to timing of release.
cabel Thursday, 09/14/17 08:36:29 AM
Re: None
Post # of 196732
I sent this artilce to Leo,....
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/
Interim analysis: A rational approach of decision making in clinical trial
He responded yesterday with this and based on his explanation I support him in his decision.
From Leo:
Please note the first paragraph of the article you sent me.
Quote from Abstract
Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.
From Leo:
Our plan was to to do an interim analysis of patients who completed week 6 and look for a signal. Recruitment into the study was slower than anticipated. At this time, as most patients have completed the study, a look could create investigator bias. It will likely effect the Alpha and require more patients to be added to the study.
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