THE PLACE OF STATISTICS AND EXPERIMENTAL DESIGN IN ANIMAL LABORATORY RESEARCH
Keywords:
Animal studies, experimental designs, statistical pitfalls, guidelines, accurate dataAbstract
Animal studies continue to have a vital role in science development because of large variations among individual animals,experimental designs and statistical analyses are particularly important in animal experiments .It involves some important steps in designing experimental designs and should adhere to the the ethical procedure and follow strictly the scientific method.For ethical and economic reasons, it is important to design animal experiments well, to analyze the data correctly, and to use the minimum number of animals necessary to achieve the scientific objectives—but not so few as to miss biologically important effects or require unnecessary repetition of experiments.The most critical step in designing animal experiments is the identification of the most appropriate animal model to address the experimental question being asked. Other practical considerations include defining the necessary control groups, randomly assigning animals to control/treatment groups, determining the number of animals needed per group, evaluating the logistics of the actual performance of the animal experiments, and identifying the most appropriate statistical analyses and potential collaborators experienced in the area of study. All of these factors are critical to designing an experiment that will generate scientifically valid and reproducible data, which should be considered the ultimate goal of any scientific investigation. Experimental design is obviously a critical component of the success of any research project. If all aspects of experimental design are not thoroughly addressed, scientists may reach false conclusions and pursue avenues of research that waste considerable time and resources. It is therefore critical to design scientifically sound experiments and to follow standard laboratory practices while performing these experiments to generate valid reproducible data.The description of statistical experiments should specify the experimental variables that are to be manipulated, suitable test parameters that accurately assess the effects of experimental variable manipulation, and the most appropriate methods for sample acquisition and generation of the test data. So, in order to bring the experiments using laboratory animals should be well designed,clearly presented and correctly interpreted if they are to be ethically acceptable and to avoid the statistical pitfalls and follow the guidelines using labouratory animals in experimental designing to get the accurate results and maximize the knowledge gained from statistics and animal experiments.
Downloads
References
Altman DG, Gore SM, Gardner MJ, Pocock SJ.(2000). Statistical guidelines for contributors to medical journals, Statistics with Confidence, 2nd Ed. London: BMJ Books.
Altman DG,(2002).Poor quality medical research,What can journals do: JAMA (In Press).
Barrow J,(1991). Theories of Everything,New York: Oxford University Press.
Cobb GW,( 1998).Introduction to Design and Analysis of Experiments,New York: Springer.
Cox DR, Reid N.(2000). The theory of the design of experiments,In: Monographs on Statistics and Applied Probability, 86. Boca Raton: Chapman & Hall/CRC Press.
Dean AM, Voss D.(1999). Design and Analysis of Experiments,New York: Springer.
Dell R, Holleran S, Ramakrishnan R.(2002). Sample size determination, ILAR J 43:207-213.
Doncaster CP, Davey, A. (2007). Analysis of Variance and Covariance, How to Choose and Construct Models for the Life Sciences, Cambridge Univ: Press.
Ekwall B, Barile FA, Castano A, Clemedson C, Clothier RH, Dierickx P, Ekwall B, Ferro M, Fiskesj G, Garza-Oca˜nas L, Gomez-Lechon MJ, Golden M, Hall T, Isomaa B, Kahru A, Kerszman G, Kristen U, Kunimoto M, Krenlampi S, Lewan L, Loukianov A, Ohno T, Persoone G, Romert L, Sawyer TW, Shrivastava R, Segner H, Stammati A, Tanaka N, Valentino M, Walum E, Zucco F .(1998) .MEIC evaluation of acute systemic toxicity,Part VI, the prediction of human toxicity by rodent LD50 values and results from 61 invitro methods.Alternatives to laboratory animals : ATLA 26 Suppl 2:617–658.
EPA [Environmental Protection Agency]. (1989). Good Laboratory Practice Regulations. Federal Register 40, chapter 1, part 792.
Fairweather WR, Bhattacharyya A, Ceuppens PP, Heimann G, Hothorn LA, Kodell RL, Lin KK, Mager H, Middleton BJ, Slob W, Soper KA, Stallard N, Ventre J, Wright J. (1998). Biostatistical methodology in carcinogenicity studies. Drug Infor J 32:401-421.
Festing MFW, Altman DG.(2002). Guidelines for the design and statistical analysis of experiments using laboratory animals. ILAR J 43:244-258.
Festing MFW,(2001).Guidelines for the design and statistical analyses of experiments in papers submitted to ATLA 29:427-446.
Festing MFW, Overend P, Gaines Das R, Cortina Borja M, Berdoy M.(2002). The Design of Animal Experiments,Reducing the Use of Animals in Research Through Better Experimental Design London: Royal Society of Medicine Press Limited.
Festing MFW, Diamanti P, Turton JA.(2001). Strain differences in haematological response to chloramphenicol succinate in mice, Implications for toxicological research, Food Chem Toxicol :39:375-383
FDA [Food and Drug Administration](1987). Good Laboratory Practice Regulations. Federal Register 21, chapter 1, part 58.
Gore KH, Stanley PJ (2005).An illustration that statistical design mitigates environmental variation and ensures unambiguous study conclusions. Animal Welfare 14(4):361–365
ICMJE [International Committee of Medical Journal Editors].(2001). Uniform requirements for manuscripts submitted to biomedical journals.
Johnson PD,Besselsen DG.(2002).Prratical aspects of experimental designs in animal research.ILAR J:324-474(6).
Kuhn, T.( 1962). The Structure of Scientific Revolutions. Chicago: University of Chicago Press.
Lawson, AE.(2002). What does Galileo's discovery of Jupiter's moons tell us about the process of scientific discovery:Sci Educ ,11:1-24.
Leist M, Hartung T.(2013) Inflammatory findings on species extrapolations: humans are definitely no 70-kg mice,Archives of toxicology 87:563–567
Lemons J, Shrader-Frechette K, Cranor C. 1997. The precautionary principle: Scientific uncertainty and type I and type II errors. Found Sci 2:207-236.
Lipnick RL, Cotruvo JA, Hill RN, Bruce RD, Stitzel KA, Walker AP, Chu I, Goddard M, Segal L, Springer JA, Myers RC.(1995). Comparison of the up-and-down, conventional LD50, and fixed-dose acute toxicity procedures. Food Chem Toxicol 33:223-231
Mathews , P. (2010). Sample size calculations,Mathews Malnar and Bailey: Inc.
Maxwell SE, Delaney HD.(1989). Designing experiments and analyzing data. Belmont CA: Wadsworth Publishing Company.
Muller KE,Barton CN,Benignus VA,(1984).Rommendations for appropriate statistical practice in toxicological experiments,Neurotoxicology,5:113-126.
Pickvance CG.(2001). Four varieties of comparative analysis, J Hous Built Env. 16:7-28.
Rispin A, Farrar D, Margosches E, Gupta K, Stitzel K, Carr G, Greene M, Meyer W, McCall D. (2002). Alternative methods for the LD50 test: The up and down procedure for acute toxicity. ILAR J 43:233-243.
Romain-Daniel Gosselin,(2018).Guidelines on statistics for researchers using labouratory animals:the essentials.Article reuse guidelines –sage pub.com/journals-permissions.,37(1),28-42.
Russell WMS, Burch RL.(1959). The Principles of Humane Experimental Technique. London: Methuen & Co. Ltd. [Reissued: 1992, Universities Federation for animal Welfare, Herts, England.]
Schlede E, Mischke U, Roll R, Kayser D.(1992). A national validation study of the acute-toxic-class method-An alternative to the LD50 test, Arch Toxicol 66:455-470.
Schulz MA, Schmalbach B, Brugger P, Witt K.(2012). Analysing humanly generated random number sequences: a pattern-based approach,PloS one 7:e41,53.
Seongwon seo,seoyong jeon,and jong, kha.(2018).Guidelines for experimental design and statistical analyses in animal studies,Asian-Australas j-anim sci :31(9),1381-1386.
Simmons JP ,Nelson LD, Simohnson U.(2011).False-positive psychology,Undisclosed flexibility in data collection and analysis allows presenting anything as significant:Psychological science 22:1359–1366.
Silverman J, Suckow MA, Murthy S.(2000). The IACUC Handbook, Boca Raton: CRC Press.
Sproull NL.(1995). Handbook of Research Methods,A Guide for Practitioners and Students in the Social Sciences, 2nd ed. Metuchen: Scarecrow Press.
Stokes WS.(2000). Reducing unrelieved pain and distress in laboratory animals using humane endpoints. ILAR. J .41:59-61.
Wilson EB. (1952). An Introduction to Scientific Research,New York: McGraw-Hill.
Wilson JB, Natale SM.(2001). "Quantitative" and "qualitative" research: An analysis. Int J Value-Based Mgt ,14:1-10.
Wu CF, Hamada M.(2000). Experiments: Planning, Analysis, and Parameter Design Optimization. New York: Wiley.
Zolman JF.(1993). Biostatistics: Experimental Design and Statistical Inference, New York: Oxford University Press.
