CLINICAL TRIALS: DESIGN, CONDUCT AND STATISTICAL ANALYSES

 
 
Lecturer: Dr. Adam Svobodnik, Ph.D.
Lesson: credit
 

 

Annotation:                           clinical trials - fundamental terminology, ethical, legal and organizational aspects; statistical analyses - testing of hypotheses, experimental design, sample size, randomization, data monitoring and management

 

Designed for:                        Ph.D. students

 

Time table:                            3 afternoon lectures (a total of 12 hours)

 

 

SYLABUSSYLLABUS

PART I: Fundamental terminology, ethical and legal aspects

Fundamental terminology

Clinical trial, Phase I - IV studies, trial protocol, principal investigator, investigator, study subjects, case report form (CRF), monitor, statistician, contract research organization

Ethical and legal aspects

Main law sources in the Czech Republic and EU, harmonization, good clinical practice, Declaration of Helsinki, informed consent, ethical committee

Conduct of clinical trial

SÚKL, ethical committee, insurance, agreements, annual reports, study termination, final report, administration

Statistics in clinical trial

Study design, testing of hypotheses, sample size estimates, randomization, data management

Part II: Statistics in clinical trials - data management and analyses

Study design

Parallel design, cross-over and factorial design, Phase I - IV trials

Testing of hypotheses

Type of data in clinical trials, a and b error, power

Sample size estimates

Factors limiting sample size, fundamental equations, software tools

Randomization

Randomness, complete randomization, permuted block randomization, stratification, adaptive randomization

Data management

Case report form, double data entry, data transfer, remote data entry (RDE)

 


Literature:

 

·         Cleophas, T. , J. et al.. Statistics Applied to Clinical Trials. Kluwer Academic Publishers. 2000. 97 pp.

·         Liu, J.- Chow, S. Design and Analysis of Clinical Trials: Concepts and Methodologies. John Wiley and Sons. 1998. 648 pp.

·         Machin, D. et al. Sample Size Tables for Clinical Studies. Blackwell Science. 1987. 315 pp.

·         McFaccen, E. Management of Data in Clinical Trials. John Wiley and Sons. 1998. 210 pp.

·         Meinert, C. L. Clinical Trials: Design, Conduct and Analysis. Oxford University Press. 1996. 469 pp.

·         Norleans, M. X. Statistical Methods for Clinical Trials. Marcel Dekker. 2001. 257 pp.

·         Piantadosi, S. Clinical Trials: A Methodological Perspective. John Wiley and Sons. 1986. 469 pp.

·         Shuster, J., J. Handbook of Sample Size Guidelines for Clinical Trials. CRC Press. 1990. 854 pp.

·         Wooding, W., M. Planning Pharmaceutical Clinical tTrials. John Wiley and Sons. 1994. 529 pp.