MRes Experimental Medicine (Respiratory) / Course details

Year of entry: 2022

Coronavirus information for applicants and offer-holders

We understand that prospective students and offer-holders may have concerns about the ongoing coronavirus outbreak. The University is following the advice from Universities UK, Public Health England and the Foreign and Commonwealth Office.

Read our latest coronavirus information

Course unit details:
Designing a translational medicine strategy for a clinical intervention

Unit code MEDN69632
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Semester 2
Offered by Division of Cancer Sciences
Available as a free choice unit? No

Overview

 

The purpose of this unit is to provide a framework to consider how to optimise the chances of success in the early clinical testing of a novel intervention. Despite having a potentially excellent drug, testing it in the wrong disease type, or at the wrong schedule or dose; or with the wrong combination of agent- could terminate an otherwise promising drug. Students will gain a foundation for considering which pre-clinical experiments can be done to inform on the optimal options for clinical testing. With the help of a tutor, students will choose a scenario to the practice of relevant translational medicine within the drug development environment and constructively critique it.

 

Aims

 

  

Equip students with knowledge and skills to:

  • Understand the principles of designing translational medicine strategies for a clinical intervention including application of statistical theory  
  • Gain comprehensive knowledge of the translational research cycle
  • Understand how pre-clinical experiments should be conducted to inform the design of a first in human clinical trial
  • Prioritise the most pertinent pieces of pre-clinical data to inform the design of a first in human clinical trial
  • Explore baseline and outcome measures that define success of an intervention [for drug interventions this may include the use of pharmacodynamics biomarkers to demonstrate unequivocal evidence of biological activity; for non-drug interventions, other clinical indicators will be explored and evaluated] 
  • Prioritise in a resource constrained environment which pre-clinical experiments are critical to attaining the next milestone and enlightening the clinical plan beyond that milestone
  • Understand how to interpret data from Phase 1 clinical studies including measures of safety and efficacy

 

Learning outcomes

 

Knowledge and understanding

 

ILO1: Understand the key design challenges for a first in human experiment

ILO2:  Understand the level of evidence required to credential a putative target/intervention as meritorious of clinical testing

 ILO3: Understand the steps required to validate and analyse outcome measures including biomarkers

ILO4: Understand key statistical concepts to inform EM studies, including sample size calculations, hypothesis testing and how data should be collected to facilitate statistical analysis

ILO5: Understand the key criteria for the successful preparation of an ethics submission

ILO6: Understand how to interpret outcome data from a first-in-human study

ILO7: Understand the importance of patient and public involvement in the development of EM studies

ILO8: Understand the research landscape for conducting EM studies

 

Intellectual skills

 

ILO9: Explore the development of a research idea from hypothesis to drawing of a conclusion

ILO10: Critical review of which pre-clinical translational experiments most inform the clinical plan in a resource constrained environment

ILO11: Critical appraisal of how pre-clinical experiments can inform study design and thus optimise a protocol for success; yet balance the danger of over-interpreting pre-clinical data; ILO12: Identify the key data from scientific literature and pilot studies which govern whether a new intervention should/should not progress into further clinical testing

ILO13: Make judgements on the quality of research and consider the implications for clinical practice/future research

 

Practical skills

 

ILO14: Assemble a translational strategy to support the testing of a clinical intervention in man

ILO15: Complete an application for ethical approval

ILO16: Produce patient facing literature and design consent forms

ILO17: Access and synthesis relevant scientific literature

ILO18: Overcome common challenges faced in the translation of experimental medicine studies

 

Transferable skills and personal qualities

 

ILO19: Work collaboratively with members of an inter-professional team

ILO20: Presentation of ideas and findings in a verbal and written format

ILO21: Understanding of resource allocation, project planning and time management

ILO22: Understanding of how EM research applies to the development of a clinical discipline and to an individual’s clinical career

 

ILO23: Identification and the solving of problems that are complex and involve multiple stakeholders

ILO24: Demonstration of professional behaviour and insight into working within the limits of individual professional competence referring, as appropriate, to senior staff

 

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback on assessed work is given to students via Turnitin.

Study hours

Scheduled activity hours
Tutorials 20
Independent study hours
Independent study 130

Teaching staff

Staff member Role
Rachel Watson Unit coordinator
Kai Uus Unit coordinator
Jaclyn Smith Unit coordinator
Benjamin Parker Unit coordinator

Return to course details