Design and Delivery of Further Clinical Trials - Short Course

Program Overview

This advanced course in clinical trials design and delivery explores various trial designs, including adaptive, cluster, factorial, and cross-over trials, emphasizing their advantages and challenges. It also covers feasibility studies, pilot trials, and the integration of qualitative research into trials. Assessed through an unseen exam and a design task, the course equips students with the knowledge and skills to design and deliver effective clinical trials.

Program Outline

Degree Overview:

This short course, "Design and Delivery of Further Clinical Trials," is a core module within the MSc/PGDip Clinical Trials program. Alternatively, it can be taken as a standalone course. The course focuses on advanced trial designs, such as adaptive, cluster, factorial, and cross-over trials, building upon the fundamental concepts and features of clinical trial design and delivery covered in earlier modules. It explores the advantages and challenges of each design from various perspectives, including patients, funders, investigators, biostatisticians, and trial management staff. The course also delves into feasibility studies and pilot trials, which are often necessary to inform definitive trials, particularly when evaluating complex interventions or recruiting participants for challenging trials. It examines how qualitative research can be integrated into trials to enhance the efficiency of answering research questions. The objective of the course is to equip students with a comprehensive understanding of available trial designs and their appropriate applications.

Assessment:

The course assessment consists of two components:

• Unseen Examination (40%): A 2-hour examination covering the course material.
• Design Task (60%): A 2500-word task requiring students to design a clinical trial.

Teaching:

The course employs a variety of teaching methods, including:

• Lectures: Providing foundational knowledge and theoretical frameworks.
• Seminars: Facilitating interactive discussions and critical analysis of concepts.
• Tutorials: Offering personalized guidance and support for individual learning.
• Practical Classes/Workshops: Providing hands-on experience and skill development.
• Guided Independent Study: Encouraging self-directed learning and exploration of specific topics.

Other:

• Prerequisites: The course requires prior knowledge of introductory RCT trial design or experience working within trials.
• Attendance: The course requires attendance for two block weeks of teaching.