MS923-20 Management of Patient-Centred Research

Department: Warwick Medical School
Level: Taught Postgraduate Level
Module leader: John Davey
Credit value: 20
Module duration: 9 weeks
Assessment: 100% coursework
Study location: Distance or Online Delivery

Introductory description

This module provides students with theoretical and practical perspectives of the conduct of patient-centred research. Students will explore issues related to the management of clinical trials, safety monitoring, regulatory issues, data analysis, reporting of trials and contemporary study designs.

Module web page

Module aims

This module enables students to:

Demonstrate data management and analysis approaches relevant to clinical trials.
Consider issues of safety and regulatory obligations involved in managing clinical trials.
Communicate effectively and clearly on clinical trial design, management, and outcomes.

Outline syllabus

This is an indicative module outline only to give an indication of the sort of topics that may be covered. Actual sessions held may differ.

The outline syllabus gives an indication of the sort of topics that will be covered in the module.

Ethics, privacy, and safety in clinical trials.
Clinical Trial management and conduct.
Measurement of clinical trials and data capture.
Data monitoring and analysis.
Reporting of results.
Regulatory issues in clinical trials.

Learning outcomes

By the end of the module, students should be able to:

1. Use appropriate project management techniques to manage clinical trials.
2. Identify and discuss important issues in data management in clinical trials.
3. Critically evaluate safety monitoring issues in clinical trials.
4. Compare and contrast local and international and global regulatory issues affecting the design and execution of clinical trials.
5. Identify the appropriate data analysis techniques appropriate to particular study objectives.
6. Evaluate the key elements of longitudinal data analysis and meta-analysis.
7. Explain contemporary clinical trial designs, including adaptive and translational study designs.
8. Demonstrate the capacity to communicate information on clinical trial design, conduct and outcomes to a range of audiences.

Interdisciplinary

Clinical practice necessitates collaboration across disciplines, and it is appropriate that this is reflected in the Masters in Clinical Research. The module is designed to appeal to a range of clinical professionals, including medical, nursing, pharmaceutical, bioscience and other disciplines.

International

The course will recruit from (and be delivered in) multiple territories, and the content will be tailored to the students’ own territories, reflecting local and international standards for clinical research integrity.

Subject specific skills

Subject-specific skills that will be obtained from the module include:

Project management.
Data analysis and evaluation.
Appreciation of regulatory frameworks.
Change management.

Transferable skills

Improvement of a range of transferable skills, including:

Written communication.
Organisation and time management.
Thinking and problem solving.
Numeracy.
Adaptability and flexibility.

Study time

Type	Required
Online learning (scheduled sessions)	30 sessions of 1 hour (15%)
Online learning (independent)	130 sessions of 1 hour (65%)
Assessment	40 hours (20%)
Total	200 hours

Private study description

No private study requirements defined for this module.

Costs

No further costs have been identified for this module.

You must pass all assessment components to pass the module.

Assessment group A

	Weighting	Study time	Eligible for self-certification
Assessment component
Presentation on the management of Patient-Centred Research	20%	10 hours	Yes (extension)
A 10-minute pre-recorded presentation on the management of Patient-Centred Research. Students will be given a scenario of patient-centred research and will be required to provide a critical review of the key issues inherent in developing, implementing, monitoring and reporting the research. The scenarios will be selected to highlight issues related to design, ethics and/or governance of research. The protocol will provide a justification of the chosen trial design, consider issues of patient / public involvement and key issues around feasibility of the trial (resources, regulatory obligations, timelines, compliance etc.). Sample scenario 1 You are the Clinical Research Manager at a pharmaceutical company, recently partnering with government on the development of a new clinical vaccine trial in your region. The local public health department has asked you to make a brief presentation to local government employees to provide information and advice around how to you plan to engage and enrol patients from groups that are commonly under-represented in clinical trials. Your presentation should address the following points: Describe what groups are commonly under-represented in clinical trials. Illustrate the main features of the proposed trial in terms of data management, safety and common regulatory procedures. Summarise how regulatory procedures may both hinder and help the engagement of those from under-represented backgrounds. Suggest steps that could be taken to make the biggest impact for the trial and engagement of under-represented groups.
Reassessment component is the same
Assessment component
Critical review of management issues related to Patient-Centred Research	80%	30 hours	Yes (extension)
A 3,200-word critical review of provided scenarios to evaluate and manage issues inherent in developing, implementing, monitoring and report patient-centred research. Students will be given 2 scenarios of patient-centred research and will be required to provide a critical review of the key issues inherent in developing, implementing, monitoring and reporting the research. The scenarios will be selected to highlight issues related to design, ethics and/or governance of research. Students will be asked to describe mechanisms for the resolution of the issues. Sample scenario 1 You are the Principal Investigator for your site as part of a Phase III multicentre double-blind placebo-controlled randomised clinical trial. A doctor working on the trial has just informed you that one of the trial participants has mistakenly taken twice the prescribed dose of their daily trial medication for the past two weeks. You do not know if the patient is taking trial medication or placebo. With reference to the literature, critically evaluate your options and proposed solutions, taking account of the safety, ethical, governance and regulatory implications. You should also consider implications for both the patient and the future conduct of the trial. Sample scenario 2 You are the Principal Investigator managing multiple sites for a Phase III clinical trial of a new medication for Alzheimer’s disease. A research nurse at one of the centres has informed you they are concerned that the patient recruitment criteria are not being followed properly at their site. They are also concerned about the accuracy and completeness of the patient case record files. With reference to the literature, critically evaluate your options and proposed solutions, taking account of the safety, ethical, governance and regulatory implications. You should also consider implications for the future conduct of the trial.
Reassessment component is the same

Feedback on assessment

The critical review will be marked and moderated using a standardised rubric based on the following assessment criteria:

analysis
application
communication
evaluation
knowledge
understanding
Feedback, including marks, will be given electronically to students.

The pass mark is 50% overall.
It is not necessary to pass each component of the module independently.
We will apply a compensatory grading approach that will enable students to carry a failed component, as long as their aggregated mark is at least 50%.

There is currently no information about the courses for which this module is core or optional.