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Wednesday, December 27, 2023 12:25:55 PM
Doesn't matter where the Odds Ratio ranks in the SAP, if such a ranking exists.
(Starting here it's all me without my friend's input.) If a trial sponsor pre-specifies various statistical analyses, it creates a problem called multiplicity. Choosing one of various ways to analyze data ad-hoc is one of several means of doing what's called p-hacking. This problem of multiplicity is controlled in part by putting the onus on the sponsor to first-list the analysis it wants the FDA to depend on. If the sponsor can choose among different analyses, it has a much better chance of finding a significant p-value; but the other analyses are actually showing the trial failed on that endpoint.
Here are a couple quotes to help give a sense of the problem:
[T]here are many different ways to implement multiple imputation, such as including different variables in the imputation model and imputing under different statistical models. Therefore, this approach to pre-specification is ineffective, as it still allows investigators to analyse the data in many different ways before deciding on a final approach. This issue of ‘incomplete’ pre-specification, where methods are pre-specified to some extent but the specification still allows for some degree of p-hacking, is common in clinical trials.
The second discrepancy, termed an ‘addition’, occurred when the original analysis plan gave the investigators flexibility to subjectively choose the final analysis method after seeing trial data. This could occur if the original analysis plan (i) contained insufficient information about the proposed analysis or (ii) allowed the investigators to subjectively choose between multiple different potential analyses.
The football analogy doesn't work. I can't come up with a good analogy, but this is closer: I say I have a great way to pick stocks and I list ten that will go up over the next month, and then I want you to confirm my method by looking at only the winners.
Recent AVXL News
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- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
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- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
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- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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