LBIOL52105A Statistical Principles Applied to Clinical Trials Course Descriptor subject to approval

Course Overview

This course is an intensive two-week bootcamp where learners will gain insight into the principles of statistics and how they help to make decisions on the outcome of clinical trials. The course examines statistical principles used in the analysis of clinical trial data: power and sample size, randomisation, odds ratios, confidence intervals, p values, significance, intention-to-treat and per protocol analysis, multiplicity, equivalence and non-inferiority, and futility. Finally, the course also explores how to effectively present and communicate basic statistical methods.

Learning Outcomes

On successful completion of the course, learners will be able to:

Knowledge and Understanding

Subject Specific Skills

Transferable and Professional Skills

Teaching and Learning

This is an e-learning course, taught throughout the year. 

This course can be offered as a standalone short course.

Teaching and learning strategies for this course will include: 

• Online learning
• Online discussion groups
• Online assessment

Course information and supplementary materials will be available on the University’s Virtual Learning Environment (VLE).

Learners are required to attend and participate in all the formal and timetabled sessions for this course. Learners are also expected to manage their self-directed learning and independent study in support of the course.

The course learning and teaching hours will be structured as follows:

• Off-the-job learning and teaching (10 days x 7 hours) = 70 hours
• On-the-job learning (8 days x 7 hours) = 56 hours
• Private study (4 hours per week) = 24 hours

Total = 150 hours

Workplace assignments (see below) will be completed as part of on-the-job learning.

Assessment

Summative

Feedback

Learners will receive formal feedback in a variety of ways: written (via email or VLE correspondence) and indirectly through online discussion groups. Learners will also attend a formal meeting with their Academic Advisor or Success Manager (and for apprentices, including their Line Manager). These bi or tri-partite reviews will monitor and evaluate the learner’s progress.  

Feedback is provided on summatively assessed assignments and through generic internal examiners’ reports, both of which are posted on the VLE.

Indicative Reading

Note: Comprehensive and current reading lists for courses are produced annually in the Course Guide or other documentation provided to students; the indicative reading list provided below is used as part of the approval/modification process only.

Books

• Cleophas, T. J. M., Zwinderman, A. H., Cleophas, T. F., Cleophas, E. P., & Cleophas-Allers, H. I. (2012). Statistics applied to clinical studies (5th ed.). Springer.
• Everitt, Brian., & Pickles, Andrew. (2004). Statistical aspects of the design and analysis of clinical trials (Rev. ed.). Imperial College Press.
• Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials (Fifth edition.). Springer.
• Proschan, M. A., & Barreiro-Gomez, J. (2022). Statistical thinking in clinical trials (First edition.). CRC Press, Taylor & Francis Group.
• Young, W. R., & Chen, D.-G. (Eds.). (2015). Clinical trial biostatistics and biopharmaceutical applications. CRC Press.

Journals

Learners are encouraged to read material from relevant journals on chemistry for the life sciences as directed by their course leader.

Electronic Resources

Learners are encouraged to consult relevant websites on the history and general design of clinical trials.

Indicative Topics

Students will study the following topics:

• Sample size
• Analysis and interpretation of data
• Problem-solving

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