Course Length : Regular - 90 Days, Fastrack - 60 Days
Course Start : For Details Call +91 9247716307,
Limited seats per batch
Course Location : Hyderabad, India
Contact Us : Call +91 9247716307


STRONGLY Suggested Textbook (Not Required):
Friedman LM, Furberg CD, DeMets DL. (2010). Fundamentals of Clinical Trials (4th Ed.), New York, NY: Springer.
Other Useful Reference Books on General Clinical Trials:

1. Green S, Crowley J, Benedetti J, Smith A. (2003). Clinical Trials in Oncology (2nd Ed.),
Chapman and Hall/CRC.
2. Crowley J, Hoering A. Handbook of Statistics in Clinical Oncology (3rd Ed.), Chapman and Hall/CRC.
3. Piantadosi S. (2005). Clinical Trials: A Methodologic Approach (2nd Ed.), New York, NY: Wiley.
4. Chow SC, Liu JP. (1998). Design and Analysis of Clinical Trials. New York, NY: Wiley.
5. Pocock SJ. (1983). Clinical Trials: A Practical Approach. Chichester: Wiley.
. Bio-Statistics:
1. Introduction to Biostatics including definition and scope.
2. Health information system in collection of data
3. Uses, Merits & Demerits
4. The design of experiments
5. Sampling and observational studies
6. Data Collection
7. Summarizing
8. Presenting data
9. Probability
10. Frequency Distribution tables
11. Normal distribution and Estimations
12. Possession and Binomial Distribution
13. Mean, Median, Mode, Comparing the mean of small samples (Standard error of
14. Confidence Limit
15. Data tabular presentation, pictogram
16. Graphical Presentation
17. Significance test
18. Measure of variance – range, interquartral range, Average Deviation, Standard
19. Analysis of variance coefficient of variance
20. Correlation and Regression
21. Method based on Rank order:- Non-parameter methods, The Mann-Whitney U test.
22. Wilcoxon matched pair test. Spearman‟s rank correlation coefficient, P, Kendall‟s
rank correlated coefficients, t, continuity correlation parameteric of non parametric
23. The Analysis of cross tabulations : the Chi-square test
24. Z Text.
25. F Test.
26. t test – paired and unpaired



This course will introduce the fundamental concepts used in the design of clinical trials and
statistical methodology associated with trial data analysis.
At the end of this course students should know how to draft selected sections of a protocol that
involve biostatistical issues, should know how to read critically the results of a clinical trial as
Published in the literature, and should be able to understand the public health implications of
Clinical trials


  • Ph.Ds in any science discipline
  • Postgraduates with specialization in any of the areas of molecular biology, genetics, microbiology, structural biology, genetics, chemistry, physics, statistics and biotechnology.
  • B. Pharm, M. Pharm, MBBS, MD, BE/B. Tech, ME/M.Tech etc.
  • Final year students of the above courses as a part of fulfilling their project work.
  • Students looking for Research opportunities abroad.
  • Research Scholars in any areas of life & chemical sciences.
  • Bachelors in Biotechnology, Microbiology, Bioinformatics, Life sciences, Biochemistry, Zoology, Botany and related discipline.

Course Goal

Introduce the fundamental concepts used in the design of Phase I-III clinical trials including
endpoint determination, randomization, blinding, power, and interim stopping rules.

Present key statistical issues that need to be considered when interpreting clinical trial results especially as they pertain to public health.

Introduce statistical methodology associated with the analysis of data from clinical trials including factorial designs, crossover designs, prevention trials, and group randomized trials