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Academic Handbook Course Descriptors and Programme Specifications

LBIOL52105A Statistical Principles Applied To Clinical Trials Course Descriptor

Course Code LBIOL52105A Discipline Bioscience and Chemistry
UK Credit 15 US Credit N/A
FHEQ level 5 Date approved July 2024
Pre-requisites None
Co-requisites None
Required/Optional Required

Course Overview

This 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

K1b Describe and critically appraise the key issues to consider when designing a clinical trial and analysing trial data, as outlined in the International Council for Harmonisation Quality Guideline Q9 on Quality Risk Management.
K2b Apply and evaluate the key components required to allocate subjects in treatment groups and estimate the sample size of a clinical trial for inferiority, equivalence, and superiority in an employment context.
K3b Critically understand the meaning of multiplicity issues in clinical trials.

Subject Specific Skills

S1b Critically reflect on statistical approaches used in the design, conduct and analysis of clinical trials.
S2b Interpret the results of analyses of clinical trials.
S3b Present and communicate basic statistical methods effectively.

Transferable and Professional Skills

T1b Exercise personal responsibility in life-long learning, using reflective practice and actively seeking the views of others.
T2b Apply problem-solving and time management skills to work creatively and effectively to develop solutions to problems.
T3b

 

 

Demonstrate a sound technical proficiency in written English and skill in selecting vocabulary so as to communicate clear arguments and critical analysis to specialist and non-specialist audiences.

 

T4b Work effectively with others and promote inclusivity, diversity, integrity and professionalism.

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 (6 days x 7 hours) = 42 hours
  • On-the-job learning (12 days x 7 hours) = 84 hours (e.g. 2 days per week for 6 weeks)
  • 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

Formative

Learners will be formatively assessed during the course by means of set assignments. These will not count towards the final degree but will provide students with developmental feedback. 

Summative

AE Assessment Type Weighting Duration Length
1 Practical 30% Requiring on average 10-15 hours to complete  
2 Set exercices 70% Requiring on average 25-30 hours to complete  

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

Version History

Title: LBIOL52102A Statistical Principles Applied to Clinical Trials Course Descriptor

Approved by: Academic Board

Location:Academic Handbook/Programme specifications and Handbooks/ Undergraduate Apprenticeship Programmes/BSc (Hons) Applied Biomedical Sciences with Clinical Trials Programme Specification/Course Descriptors

Version number Date approved Date published Owner Proposed next review date Modification (As per AQF4) & category number
1.0 July 2024 July 2024 Dr Helen Dawe July 2028