Designing a translational medicine strategy for a clinical intervention

MEDN69632 Designing a translational medicine strategy for a clinical intervention 15 Semester 2 Postgraduate Taught Level 6 Rachel Watson Unit coordinator Kai Uus Unit coordinator Jaclyn Smith Unit coordinator Benjamin Parker Unit coordinator Division of Cancer Sciences 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5   <div style="margin-left: 18pt"> 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.</div>     <div style="margin-left: 18pt"> 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.  <div> This unit will cover the following indicative content: <ul> <li> An introduction to how pre-clinical experimentation can inform on the preferred clinical trial to maximise the success for a new drug.</li> <li> Understand constraints to the application of novel technologies into clinical testing- both from a cost and logistical perspective</li> <li> Understand how pharmacodynamics biomarkers can inform dose and schedule and how predictive biomarkers can inform disease type and combination; which steps are required to qualify and validate a biomarker to either a clinical decision-making biomarker or an exploratory endpoint in a clinical study</li> <li> Understand the different phases of clinical drug development and the studies that go into these phases, including what can and cannot be assessed from them</li> </ul> </div> </div>       <div> Equip students with knowledge and skills to: <ul> <li> Understand the principles of designing translational medicine strategies for a clinical intervention including application of statistical theory  </li> <li> Gain comprehensive knowledge of the translational research cycle</li> <li> Understand how pre-clinical experiments should be conducted to inform the design of a first in human clinical trial</li> <li> Prioritise the most pertinent pieces of pre-clinical data to inform the design of a first in human clinical trial</li> <li> 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] </li> <li> 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</li> <li> Understand how to interpret data from Phase 1 clinical studies including measures of safety and efficacy</li> </ul> </div>     <table border="1" cellpadding="0" cellspacing="0"> <tbody> <tr> <td style="width: 158px"> Knowledge and understanding</td> <td style="width: 428px">  ILO1: Understand the key design challenges for a first in human experimentILO2:  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 biomarkersILO4: Understand key statistical concepts to inform EM studies, including sample size calculations, hypothesis testing and how data should be collected to facilitate statistical analysisILO5: Understand the key criteria for the successful preparation of an ethics submissionILO6: Understand how to interpret outcome data from a first-in-human studyILO7: Understand the importance of patient and public involvement in the development of EM studiesILO8: Understand the research landscape for conducting EM studies </td> </tr> <tr> <td style="width: 158px"> Intellectual skills</td> <td style="width: 428px">  ILO9: Explore the development of a research idea from hypothesis to drawing of a conclusionILO10: Critical review of which pre-clinical translational experiments most inform the clinical plan in a resource constrained environmentILO11: 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 testingILO13: Make judgements on the quality of research and consider the implications for clinical practice/future research </td> </tr> <tr> <td style="width: 158px"> Practical skills</td> <td style="width: 428px">  ILO14: Assemble a translational strategy to support the testing of a clinical intervention in manILO15: Complete an application for ethical approvalILO16: Produce patient facing literature and design consent formsILO17: Access and synthesis relevant scientific literatureILO18: Overcome common challenges faced in the translation of experimental medicine studies </td> </tr> <tr> <td style="width: 158px"> Transferable skills and personal qualities</td> <td style="width: 428px">  ILO19: Work collaboratively with members of an inter-professional teamILO20: Presentation of ideas and findings in a verbal and written formatILO21: Understanding of resource allocation, project planning and time managementILO22: 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 stakeholdersILO24: Demonstration of professional behaviour and insight into working within the limits of individual professional competence referring, as appropriate, to senior staff</td> </tr> </tbody> </table>   2 Written assignment (inc essay) 100% Feedback on assessed work is given to students via Turnitin. 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