Statistical Solutions: On the Verge of Significance: Why 5% - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Statistical Solutions: On the Verge of Significance: Why 5%
A history of the selection of the widely used significance level leaves much to be desired.


Pharmaceutical Technology
Volume 34, Issue 7, pp. 36


Lynn D. Torbeck
Statisticians and non-statisticians daily select the level of statistical significance to be used for decisions, experimental designs, data collection, sample sizes, and other formal analysis. They usually choose 5%. Why 5%? Note this definition in a well-known dictionary: "Significance level: The level of probability which it is agreed that the null hypothesis will be rejected. Conventionally set at 0.05" (1).

Thus, the Cambridge Dictionary of Statistics gives 5% as the definition of the significance level. Why 5%? Why not some other value? Is it acceptable to be wrong 5% of the time? If we choose another value, what value(s) should it be: 10%, 1%, or 0.1%?

Other writers have reflected on this as well. "Why is the 0.05 level of significance used as the decision point to reject the null hypothesis? Why not 0.06 level of significance? Actually, the 0.05 level of significance is used because of tradition. [Sir] R. A. Fisher (2), the founder of modern statistical methods, chose this value and other scientists have accepted the choice" (3).

In his landmark 1926 paper, "The Arrangement of Field Experiments," (4) Sir Ronald presented his logic for selecting confidence levels: "It will illustrate the meaning of tests of significance if we consider for how many years the [farm] produce (i.e., results) should have been recorded in order to make the evidence convincing. First, if the experimenter could say that in twenty years experience with uniform treatment the difference in favour of the acre treated with manure had never before touched 10 per cent, the evidence would have reached a point which may be called the verge of significance; ... This level, which we may call the 5 per cent. point, would be indicated, though very roughly, by the greatest chance deviation observed in twenty successive trials. ... If one in twenty does not seem high enough odds, we may, if we prefer it, draw the line at one in fifty (the 2 per cent. point), or one in a hundred (the 1 per cent. point)." Apparently, Sir Ronald was not fixated on 5%.

Fisher worked at the Rothamsted Experimental Station located in Harpenden, England, from 1919–1933 (2, 5). While there, he studied crop yields and animal husbandry using statistics and the theory of experimental designs that he developed. An incorrect decision affected only the distribution of manure on crop fields or the care and feeding of pigs and honey bees. Being wrong for 5% of the decisions wouldn't seem to be a major problem. Also, Fisher was not legalistic in his use of significance levels. Being pragmatic, he was much more concerned with the practical impact or practical significance of the results. It should be noted that Fisher developed many of the valuable statistical tables used for significance testing, and he chose levels of 0.05 and 0.01%. Thus, in effect, he forced the rest of the world to go along with his choices regardless of the application.

Other statisticians have pointed out that the selected level of 5% determines how often we will be wrong in our decisions. "In rejecting the null hypothesis, the sampler faces the possibility that he is wrong. Such is the risk always run by those who test hypotheses and rest decisions on the tests. ... As a matter of practical convenience, probability levels of 5% (0.05) and 1% (0.01) are commonly used in deciding whether to reject the null hypothesis. ... This use of 5% and 1% levels is simply a working convention. There is merit in the practice, followed by some investigators, of reporting in parentheses the probability ... (6)."

"The question arises: at what probability level does a deviation become statistically significant? There is no rational probability level at which possibility ceases and impossibility begins, but it is conventional to regard a probability of 0.05 as the critical level of significance" (7).

Thus, the hallowed 5% significance level was born from a crop experiment and a manure spreader. I am sure this gives reassurance to those benefitting from the next analysis.

Lynn D. Torbeck is a statistician at Torbeck and Assoc., 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314,
, http://www.torbeck.org/.

References

1. B.S. Everitt, The Cambridge Dictionary of Statistics (Cambridge University Press, Cambridge, MA, 1998) p. 305.

2. J.F. Box, and R.A. Fisher, The Life of a Scientist (John Wiley & Sons, New York, NY, 1978).

3. J.F. Zolman, Biostatistics, Experimental Design and Statistical Inference (Oxford University Press, Oxford, 1993) p. 84.

4. R.A. Fisher, Jrnl of the Ministry of Agric., 33, 504 (1926).

5. J.L. Folks, Ideas of Statistics (John Wiley & Sons, New York, NY, 1981) p. 245.

6. G.W. Snedecor, and W. G. Cochran, Statistical Methods, 6th ed., (Iowa State Press, Ames, IA, 1971) p. 27

7. L.H.C. Tippett, The Methods of Statistics, 4th ed., (John Wiley & Sons, New York, NY, 1951) p. 89.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
18%
To all process for new products only
13%
To select process for new products only
22%
To select processes for both new and legacy products
22%
Do not use QbD
24%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Source: Pharmaceutical Technology,
Click here