PY8071 - CLINICAL TRIALS (Syllabus) 2017-regulation Anna University

PY8071 - CLINICAL TRIALS (Syllabus) 2017-regulation Anna University

PY8071

CLINICAL TRIALS

 LPTC

3003

OBJECTIVES:
● To highlight the epidemiologic methods, study design, protocol preparation
● To gain knowledge in the basic bio-statistical techniques involved in clinical research.
● To describe the principles involved in ethical, legal and regulatory issues in clinical trials.

UNIT I

ROLE OF CLINICAL TRIALS IN NEW DRUG DEVELOPMENT

9

Drug Discovery, regulatory guidance and governance, pharmaceutical manufacturing, nonclinical research, clinical trials, post-marketing surveillance, ethical conduct during clinical trials.

UNIT II

FUNDAMENTALS OF TRIAL DESIGN

9

Randomised clinical trials, uncontrolled trials. Protocol development, endpoints, patient selection, source and control of bias, randomization, blinding, sample size and power.


UNIT III

ALTERNATE TRIAL DESIGNS

9

Crossover design, factorial design, equivalence trials, bioequivalence trials, non-inferiority trials, cluster randomized trials, multi-center trials.

UNIT IV

BASICS OF STATISTICAL ANALYSIS

9

Types of data and normal distribution, significance tests and confidence intervals, comparison of means, comparison of proportions, analysis of survival data, subgroup analysis, regression analysis, missing data.

UNIT V

REPORTING OF TRIALS

9

Overview of reporting, trial profile, presenting baseline data, use of tables, figures, critical appraisal of report, meta-analysis.

TOTAL : 45 PERIODS

OUTCOMES: The student will be able to
● Explain key concepts in the design of clinical trials.
● Describe study designs used, identify key issues in data management for clinical trials.
● Describe the roles of regulatory affairs in clinical trials.

TEXT BOOKS:
1. Fundamentals of Clinical Trials, Lawrence M. Friedman, Springer Science & Business Media, 2010
2. Textbook of Clinical Trials, David Machin, Simon Day, Sylvan Green, John Wiley & Sons, 2007
3. Clinical Trials: A Practical Approach, Stuart J. Pocock, John Wiley & Sons, 17-Jul-2013

REFERENCES:
1. Clinical trials, A practical guide to design, analysis and reporting. Duolao Wang and AmeetBakhai. Remedica. 2006.
2. Introduction to statistics in pharmaceutical clinical trials. T.A. Durham and J Rick Turner. Pharmaceutical Press.
3. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines, Tom Brody, Academic Press, 2016.

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