[NMusers] post p < .05 era

From: Kimko, Holly [JRDUS] <HKimko_at_its.jnj.com>
Date: Mon, 11 Apr 2016 17:54:36 +0000

Hello:

On March 7, 2016, the American Statistical Association announced a statemen=
t regarding p-value (click "Statement<http://amstat.tandfonline.com/doi/abs=
/10.1080/00031305.2016.1154108>"). I welcome this statement, especially bec=
ause of some clinical teams that design PoC studies to focus mainly on gene=
rating a "good p-value" for Go/No-go decisions rather than "learning". In m=
y opinion, a p-value that follows a hypothesis test could be useful but, wi=
th the same budget, a PoC study should be informative to design the next st=
udy for confirming efficacy (and/or safety) with a good p-value for a clear=
er regulatory decision.

This is a seminal paper that emphasizes the importance of clinical pharmaco=
logy approach over empirical p-value driven drug development approach:


      Learning versus confirming in clinical drug development.
      Sheiner LB<http://www.ncbi.nlm.nih.gov/pubmed/?term=Sheiner%20LB%5B=
Author%5D&cauthor=true&cauthor_uid=9084453>. Clin Pharmacol Ther.<http:=
//www.ncbi.nlm.nih.gov/pubmed/?term=peck+shiener+rubin> 1997 Mar;61(3):27=
5-91.


A recent development in considering "totality" of data in designing and/or =
approving a pediatric drug with less emphasis on p-value (my interpretation=
) can be found in:

      (Draft) Reflection paper on extrapolation of efficacy and safety in p=
aediatric medicine development (April 1, 2016) Click here<http://www.ema.eu=
ropa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201=
6/04/WC500204187.pdf>


I look forward to living in the post p< .05 era in drug development!

Kind regards,
Holly Kimko
Clinical Pharmacology & Pharmacometrics
Janssen Research & Development, LLC

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Monday, March 07, 2016 11:15 AM

Today, the American Statistical Association Board of Directors issued a sta=
tement on p-values and statistical significance. We intend the statement, d=
eveloped over many months in consultation with a large panel of experts, to=
 draw renewed and vigorous attention to changing research practices that ha=
ve contributed to a reproducibility crisis in science.
"Widespread use of 'statistical significance' (generally interpreted as 'p =
< 0.05') as a license for making a claim of a scientific finding (or implie=
d truth) leads to considerable distortion of the scientific process," says =
the ASA statement (in part). By putting the authority of the world's larges=
t community of statisticians behind such a statement, we seek to begin a br=
oad-based discussion of how to more effectively and appropriately use stati=
stical methods as part of the scientific reasoning process.
In short, we envision a new era, in which the broad scientific community re=
cognizes what statisticians have been advocating for many years. In this "p=
ost p < .05 era," the full power of statistical argumentation in all its nu=
ance will be brought to bear to advance science, rather than making decisio=
ns simply by reducing complex models and methods to a single number and its=
 relationship to an arbitrary threshold. This new era would be marked by ra=
dical change to how editorial decisions are made regarding what is publisha=
ble, removing the temptation to inappropriately hunt for statistical signif=
icance as a justification for publication. In such an era, every aspect of =
the investigative process would have its appropriate weight in the ultimate=
 decision about the value of a research contribution.
Is such an era beyond reach? We think not, but we need your help in making =
sure this opportunity is not lost.
The statement<http://amstat.tandfonline.com/doi/abs/10.1080/00031305.2016.1=
154108> is available freely online to all at The American Statistician Late=
st Articles website<http://amstat.tandfonline.com/action/showAxaArticles?jo=
urnalCode=utas20>. You'll find an introduction that describes the reasons=
 for developing the statement and the process by which it was developed. Yo=
u'll also find a rich set of discussion papers commenting on various aspect=
s of the statement and related matters.
This is the first time the ASA has spoken so publicly about a fundamental p=
art of statistical theory and practice. We urge you to share this statement=
 with appropriate colleagues and spread the word via social media. We also =
urge you to share your comments about the statement with the ASA Community =
via ASA Connect<http://community.amstat.org/home>. Of course, you are more =
than welcome to email your comments directly to us at ron_at_amstat.org<mailto=
:ron_at_amstat.org>.
On behalf of the ASA Board of Directors, thank you!
Sincerely,

Jessica Utts
President
American Statistical Association

Ron Wasserstein
Executive Director
American Statistical Association



Received on Mon Apr 11 2016 - 13:54:36 EDT

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