Hello:
On March 7, 2016, the American Statistical Association announced a statement
regarding p-value (click
"Statement<http://amstat.tandfonline.com/doi/abs/10.1080/00031305.2016.1154108>").
I welcome this statement, especially because of some clinical teams that
design PoC studies to focus mainly on generating a "good p-value" for Go/No-go
decisions rather than "learning". In my opinion, a p-value that follows a
hypothesis test could be useful but, with the same budget, a PoC study should
be informative to design the next study for confirming efficacy (and/or safety)
with a good p-value for a clearer regulatory decision.
This is a seminal paper that emphasizes the importance of clinical pharmacology
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%5BAuthor%5D&cauthor=true&cauthor_uid=9084453>.
Clin Pharmacol
Ther.<http://www.ncbi.nlm.nih.gov/pubmed/?term=peck+shiener+rubin> 1997
Mar;61(3):275-91.
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
paediatric medicine development (April 1, 2016) Click
here<http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/04/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
statement on p-values and statistical significance. We intend the statement,
developed over many months in consultation with a large panel of experts, to
draw renewed and vigorous attention to changing research practices that have
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 implied
truth) leads to considerable distortion of the scientific process," says the
ASA statement (in part). By putting the authority of the world's largest
community of statisticians behind such a statement, we seek to begin a
broad-based discussion of how to more effectively and appropriately use
statistical methods as part of the scientific reasoning process.
In short, we envision a new era, in which the broad scientific community
recognizes what statisticians have been advocating for many years. In this
"post p < .05 era," the full power of statistical argumentation in all its
nuance will be brought to bear to advance science, rather than making decisions
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 radical
change to how editorial decisions are made regarding what is publishable,
removing the temptation to inappropriately hunt for statistical significance 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/10.1080/00031305.2016.1154108>
is available freely online to all at The American Statistician Latest Articles
website<http://amstat.tandfonline.com/action/showAxaArticles?journalCode=utas20>.
You'll find an introduction that describes the reasons for developing the
statement and the process by which it was developed. You'll also find a rich
set of discussion papers commenting on various aspects of the statement and
related matters.
This is the first time the ASA has spoken so publicly about a fundamental part
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
r...@amstat.org<mailto:r...@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
