LBIOL4274A Introduction to Clinical Trials Course Descriptor

Course Overview

The course describes the lifecycle pertaining to clinical trials, from the planning at the very start of the study to the study close-out, and provides some insight into key stakeholders (sponsors, Contract Research Organisations (CROs), sites and patients). It also considers (clinical) research design and the factors that influence the success (or the failure) of clinical trials.

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 (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

Students 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

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

Friedman, Lawrence M. (2010). Fundamentals of Clinical Trials.  (4th ed.). New York, NY: Springer

Hulley, S.B., Cummings, S.R., Browner W.S., Grady D.G. and Newman T.B. (2013). Designing Clinical Research. (3rd ed.). Philadelphia : Wolters Kluwer/Lippincott Williams & Wilkins.

Piantadosi, S., & Meinert, C. L. (Eds.). (2022). Principles and practice of clinical trials. Springer.

Journals

Learners are encouraged to read material from relevant journals on the lifecycle of clinical trials 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

Learners will study the following topics:

• Lifecycle of clinical trials
• Outlines of the research design
• Bias

Version History