Welcome
To Research
in Statistics,
Mathematics,
and
SAS programming
We have
technical expertise in Statistical Analysis Plan, Reporting and interpreting
analysis results, SAS programming,
and Validation of TFLs (Safety and
Efficacy tables, figures, listings using SAS
or S-Plus/R.) for clinical trials in phases I-IV. We have expertise in most of
therapeutic areas and our specialties are Oncology, Osteoporosis, Diabetes,
Alzheimer's disease and Cardiovascular, Chronic Obstructive Pulmonary Disease (COPD), devices such Elite SPY, surgical
Mesh analysis. We have over 20 years of pharmaceutical
experiences and clinical data manipulation. We had played great role in number
of successful NDA submissions within
pharmaceutical industries. We are familiar with FDA requirements and
knowledgeable of drug approval process, ICH
guidelines, GCP, and
EMEA. We can take your clinical trial
studies to a successful FDA submission using CRT (Case Report Tabulation) for
electronic submissions, implementing SOPs and Working Guidelines.
We have expertise working
with the following statistical and mathematical software packages:
SAS, R, WinBugs, BUGS, East, Adaptive,
Bayesian, JMP, nQuery, MATHLAB, IBM-SPSS, NCSS/PASS.
To discuss more in detail how we can help you to
design clinical trials and to reach to
your successful FDA submissions, please get in touch with us.
Articles to consider for Clinical Trial
Design
About 10000 clinical trials are undertaken annually in all
areas of medicine, from the treatment of acne to the
prevention of cancer. Correct interpretation of the data
from such trials depends largely on adequate design and on
performing the appropriate statistical analyses. The
statistical aspects of both the design and analysis of
trials are important, with particular emphasis on recently
developed methods of analysis.
|
1. Guidance for
determining the number of centers in clinical trials
2. Guidelines on Data Safety and
Monitoring
This guideline is to provide
the oversight and necessity of interim monitoring to ensure the safety of the
study participants and the validity and integrity of the trial data. Phase III
clinical trials usually have a Data and Safety monitoring Board (DSMB), with
broad responsibility for monitoring the conduct of the trial.
3. Guidelines
for the Creation of Analysis Data Files and Documentation of Statistical
Analyses for Submission
Optimal Two-Stage Designs For Phase II Clinical TrialsThe
purpose of this document is to provide guidelines for the creation of analysis
data sets
and associated documentation that are submitted to the FDA statistical reviewer
in support of the
primary and important secondary study objectives.
4. Guidance for Contents of the Clinical Study Report
The purpose of this document is to provide guidelines on what information need
to be included in statistical section of the Clinical Study Report (CSR).
5. Guidance for Non-Inferiority Clinical Trials
6. Fundamentals of Biostatistics ( 1. Clinical
Trials (RCT), 2. Validity/Reliability, 3. Assessing Evidence)
Oncology: Optimal Two-Stage Designs For Phase II Clinical Trials
Richard Simon:
Optimal Two-Stage Designs
Example of this Calculation
Your input
Alpha --------------------------------------------> 0.10
Beta ---------------------------------------------> 0.10
Response Probability of Poor Drug (P0) ---> 0.40
Response Probability of Good Drug (P1) ---> 0.60
===================================================================
Your Output
Optimal Two Stage Design |
Optimum Design |
MinMax Design |
First Stage Sample Size (n1) |
18 |
28 |
Upper Limit For 1st Stage Rejection of Drug (r1) |
7 |
11 |
Maximum Sample Size (n) |
46 |
41 |
Upper Limit for 2nd Stage Rejection of Drug (r) |
22 |
20 |
Expected Sample Size If Response Probability = P0 |
30.22 |
33.84 |
Probability of Early Termination at P0 |
0.56 |
0.55 |
Correlated Proportions








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Publisher:
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Statistical Literature
- Altman DG (1980)
Statistics and ethics in medical research. VI - Presentation of results.
British Medical Journal 281:1542-1544.
- Altman DG (1991) Practical
statistics for medical research. London: Chapman and Hall.
- Altman DG (1998)
Confidence intervals for the number needed to treat. British Medical
Journal 317: 1309-1312.
- Altman DG, Gardner MJ
(1988) Calculating confidence intervals for regression and correlation.
British Medical Journal 296:1238-1242.
- Altman DG, Gore SM,
Gardner MJ, Pocock SJ (1983) Statistical guidelines for contributors to
medical journals. British Medical Journal 286:1489-1493.
- Armitage P (1955) Tests
for linear trends in proportions and frequencies. Biometrics 11:375–386.
- Armitage P, Berry G,
Matthews JNS (2002) Statistical methods in medical research. 4th ed.
Blackwell Science.
- Bland M (2000) An
introduction to medical statistics, 3rd ed. Oxford: Oxford University
Press.
- Bland JM, Altman DG (1986)
Statistical method for assessing agreement between two methods of
clinical measurement. The Lancet i:307-310.
- Bland JM, Altman DG (1995)
Comparing methods of measurement: why plotting difference against
standard method is misleading. The Lancet 346:1085-1087.
- Bland JM, Altman DG (1997)
Statistics notes: Cronbach's alpha. British Medical Journal 314:572.
- Bland JM, Altman DG (1999)
Measuring agreement in method comparison studies. Statistical Methods in
Medical Research, 8:135-160.
- Bland JM, Altman DG (2007)
Agreement between methods of measurement with multiple observations per
individual. Journal of Biopharmaceutical Statistics. 17:571-582.
- Bulpitt CJ (1987)
Confidence intervals. The Lancet i:494-497.
- Campbell MJ, Gardner MJ
(1988) Calculating confidence intervals for some non-parametric
analyses. British Medical Journal, 296:1454-1456.
- CLSI (2008) Defining,
establishing, and verifying reference intervals in the clinical
laboratory: approved guideline - third edition. CLSI Document C28-A3.
Wayne, PA: Clinical and Laboratory Standards Institute.
- Cohen J (1960) A
coefficient of agreement for nominal scales. Educational and
Psychological Measurement 20:37-46.
- Conover WJ (1999)
Practical nonparametric statistics, 3rd edition. New York:
John Wiley & Sons.
- Cornbleet PJ, Gochman N
(1979) Incorrect least-squares regression coefficients in
method-comparison analysis. Clinical Chemistry 25:432-438.
- Cronbach LJ (1951)
Coefficient alpha and the internal structure of tests. Psychometrika
16:297-334.
- Daly LE (1998) Confidence
limits made easy: interval estimation using a substitution method.
American Journal of Epidemiology 147: 783-1998.
- DeLong ER, DeLong DM,
Clarke-Pearson DL (1988): Comparing the areas under two or more
correlated receiver operating characteristic curves: a nonparametric
approach. Biometrics 44:837-845.
- Dewitte K, Fierens C,
Stöckl D, LM Thienpont (2002) Application of the Bland-Altman plot for
interpretation of method-comparison studies: a critical investigation of
its practice. Clinical Chemistry 48:799-801.
- Feldt LS (1965) The
approximate sampling distribution of Kuder-Richardson reliability
coefficient twenty. Psychometrika 30:357-371.
- Fleiss JL (1981)
Statistical methods for rates and proportions, 2nd edn. New York: John
Wiley & Sons.
- Fleiss JL, Levin B, Paik
MC (2003) Statistical methods for rates and proportions, 3rd ed.
Hoboken: John Wiley & Sons.
- Gardner MJ, Altman DG
(1986) Confidence intervals rather than P values: estimation rather than
hypothesis testing. British Medical Journal 292:746-750.
- Girden ER (1992) ANOVA:
repeated measures. Sage University Papers Series on Quantitative
Applications in the Social Sciences, 84. Thousand Oaks, CA: Sage.
- Glantz SA, Slinker BK
(2001) Primer of applied regression & analysis of variance. 2nd ed.
McGraw-Hill.
- Greenhouse SW, Geisser S
(1959) On methods in the analysis of profile data. Psychometrika
24:95-112.
- Griner PF, Mayewski RJ,
Mushlin AI, Greenland P (1981) Selection and interpretation of
diagnostic tests and procedures. Annals of Internal Medicine,
94:555-600.
- Grubbs FE (1969)
Procedures for detecting outlying observations in samples. Technometrics
11:1-21.
- Hanley JA, Hajian-Tilaki
KO (1997) Sampling variability of nonparametric estimates of the areas
under receiver operating characteristic curves: an update. Academic
Rediology 4:49-58.
- Hanley JA, McNeil BJ
(1982) The meaning and use of the area under a receiver operating
characteristic (ROC) curve. Radiology 143:29-36.
- Hanley JA, McNeil BJ
(1983) A method of comparing the areas under receiver operating
characteristic curves derived from the same cases. Radiology
148:839-843.
- Hilgers RA (1991)
Distribution-free confidence bounds for ROC curves. Methods of
Information in Medicine, 30:96-101.
- Huitema BE (1980) The
analysis of covariance and alternatives. Wiley-Interscience.
- Husted JA, Cook RJ,
Farewell VT, Gladman DD (2000) Methods for assessing responsiveness: a
critical review and recommendations. Journal of Clinical Epidemiology
53:459-168.
- Huynh H, Feldt LS (1976)
Estimation of the Box correction for degrees of freedom from sample data
in randomised block and split-plot designs. Journal of Educational
Statistics 1:69-82.
- Jones R, Payne B (1997)
Clinical investigation and statistics in laboratory medicine. London:
ACB Venture Publications.
- Krouwer JS (2008) Why
Bland-Altman plots should use X, not (Y+X)/2 when X is a reference
method. Statistics in Medicine 27:778-780.
- Krouwer JS, Monti KL
(1995) A simple, graphical method to evaluate laboratory assays. Eur J
Clin Chem Clin Biochem 33:525-527.
- Lecoutre B (1991) A
correction for the e approximate test in repeated measures designs with
two or more independent groups. Journal of Educational Statistics
16:371-372.
- Lin L.I-K (1989) A
concordance correlation coefficient to evaluate reproducibility.
Biometrics 45:255-268.
- Lin L.I-K (2000) A note on
the concordance correlation coefficient. Biometrics 56:324-325.
- Lentner C (Ed) (1982)
Geigy Scientific Tables, 8th edition, Volume 2. Basle: Ciba-Geigy
Limited.
- McBride GB (2005) A
proposal for strength-of-agreement criteria for Lin's Concordance
Correlation Coefficient. NIWA Client Report: HAM2005-062.
- McGill R, Tukey JW, Larsen
WA (1978) Variations of box plots. The American Statistician, 32:12-16.
- McGraw KO, Wong SP (1996)
Forming inferences about some intraclass correlation coefficients.
Psychological Methods 1:30-46. (Correction: 1:390).
- Metz CE (1978) Basic
principles of ROC analysis. Seminars in Nuclear Medicine 8:283-298.
- Moses LE (1987) Graphical
methods in statistical analysis. Annual Review of Public Health
8:309-353.
- NCCLS (2000) How to define
and determine reference intervals in the clinical laboratory: approved
guideline - second edition. NCCLS document C28-A2. Wayne, PA: NCCLS.
- Neter J, Kutner MH,
Nachtsheim CJ, Wasserman W (1996) Applied linear statistical models. 4th
ed. McGraw-Hill.
- Norman GR, Wyrwich KW,
Patrick DL (2007) The mathematical relationship among different forms of
responsiveness coefficients. Quality of Life Research 16:815-822.
- Pampel FC (2000) Logistic
regression: A primer. Sage University Papers Series on Quantitative
Applications in the Social Sciences, 07-132. Thousand Oaks, CA: Sage.
- Passing H, Bablok W (1983)
A new biometrical procedure for testing the equality of measurements
from two different analytical methods. Application of linear regression
procedures for method comparison studies in Clinical Chemistry, Part I.
J Clin Chem Clin Biochem 21:709-720.
- Petrie A, Bulman JS,
Osborn JF (2003) Further statistics in dentistry. Part 8: systematic
reviews and meta-analyses. British Dental Journal 194:73-78.
- Pocock SJ (1984) Clinical
trials. A practical approach. Chichester: John Wiley & Sons.
- Reed AH, Henry RJ, Mason
WB (1971) Influence of statistical method used on the resulting estimate
of normal range. Clinical Chemistry 17:275-284.
- Rosner B (1983) Percentage
points for a generalized ESD many-outlier procedure. Technometrics
25:165-172.
- Schoonjans F, De Bacquer
D, Schmid P (2011) Estimation of population percentiles. Epidemiology
22: 750-751.
- Schwartz D, Mayaux MJ
(1980) Mode of evaluation of results in artificial insemination. In:
Human Artificial Insemination and Semen Preservation (eds David G and
Price WS). New York: Plenum Press, pp 197-210.
- Sheskin DJ (2004) Handbook
of parametric and nonparametric statistical procedures. 3rd ed. Boca
Raton: Chapman & Hall /CRC.
- Sheskin DJ (2011) Handbook
of parametric and nonparametric statistical procedures. 5th ed. Boca
Raton: Chapman & Hall /CRC.
- Shrout PE, Fleiss JL
(1979) Intraclass correlations: uses in assessing rater reliability.
Psychological Bulletin 86:420-428.
- Snedecor GW, Cochran WG
(1989) Statistical methods, 8th edition. Ames, Iowa: Iowa State
University Press.
- Spiegel MR (1961) Theory
and problems of statistics. New York: McGraw-Hill Book Company.
- Tukey JW (1977)
Exploratory data analysis. Reading, Mass: Addison-Wesley Publishing
Company.
- Wildt AR, Ahtola OT (1978)
Analysis of covariance. Sage Publications.
- Zhou XH, NA Obuchowski, DK
McClish (2002) Statistical methods in diagnostic medicine. New York:
Wiley.
- Zweig MH, Campbell G
(1993) Receiver-operating characteristic (ROC) plots: a fundamental
evaluation tool in clinical medicine. Clinical Chemistry 39:561-577.
-
Chemical tables: elements, constants,
acid/base constants... All tables © C.D.
Schaeffer, Jr., C.A. Strausser, M.W. Thomsen,
and C.H. Yoder
-
ChemTutor - A site featuring units,
measures, & dimensions
-
Conversion of Units - Conversion calculator
by the Freie Universität Berlin (English and
German versions)
-
IFP Metric Conversion Tables - Conversions
from and to metric, imperial and U.S.
measurement systems
-
NIST Reference on constants, units and
uncertainties - Latest (1998) values for
constants
-
The Merck Index Online