MRes Experimental Cancer Medicine
Course Content
Students will attend Modules 1 and 2 in the first semester (September 1-Dec 31st), module 3 in the
second semester (January 1-April 30 and module 4 in the third semester (May 1-August 31).
Module 1- “Research Methods Course Unit” (15 credits)
Interactive blended learning unit which will give students a comprehensive introduction to key
information and skills required for the design, execution, interpretation and dissemination of
medical, scientific and clinically-related research. It will help provide skills to produce a high quality
dissertation and provide students with the strongest grounding possible to carry out successful
research, whether in academic, industry or a medically-aligned profession. The unit is a blended
combination of lectures, workshops and on-line material designed to cover topics relating to critical
analysis of scientific/medical research literature, information management, study design, basis
statistical analysis, research integrity, research presentation skills, scientific writing and publishing
skills
Module 2- “An Experimental Cancer Medicine Unit” (15 credits)
Interactive blended learning unit which will give students a comprehensive introduction to practical
skills and knowledge for designing, delivering and interpreting the four categories of Phase 1 clinical
trials- (i) first in human, (ii) first in combination (iii) regulatory clinical pharmacology (iv) Phase 0 nonCTIMP studies. The unit combines lectures with workshops during which students will be provided
with real examples of data and role-play safety review meetings to determine whether to escalate
doses in a first in human/combination study; or role-play a research ethics committee to determine
whether a study should be approved
Module 3- “Assembling pre-clinical and early clinical development strategies for a new candidate
drug”.
The purpose of this module is to provide a foundation and appreciation of what has to be considered
in planning and designing the pre-clinical strategy for a new candidate drug. A wide range of issues
has to be considered before a drug is dosed in man. Amongst these is whether the preclinical toxicity
supports entry into man, and if so, whether the first in man study should be performed in patients or
healthy volunteers and what the initial starting dose should be? A basic understanding of drug
handling will also be provided, along with the preclinical pharmacokinetic and pharmaceutical
development packages required. Students will also receive a foundation and appreciation of what
has to be considered in assembling an early clinical strategy for a new candidate drug. A wide range
of issues have to be considered ranging from whether the first human studies should be performed
in healthy volunteers or patients, what is a safe starting dose, how to set the upper dose limit, and
determination of drug pharmacokinetics, tolerability and early markers of efficacy. All of this is
required if clear ‘go/no go’ criteria for progression of the drug into further clinical development are
to be put in place and adhered to.
Module 4: “Assembling a translational medicine strategy for an anti-cancer drug”.
The purpose of this module is to provide a framework to consider how to optimise the chances of
success in the early clinical testing of a novel cancer drug. Despite having a potentially wonderful
drug, testing it in the wrong cancer 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 what pre-clinical experiments can be done to inform on the optimal options for
clinical testing. Students will participate in real-life scenarios to the practice of translational medicine
within the drug development environment. It will draw upon the formal teaching received in
modules 2, 3 and 4. It will address three common, yet critical scenarios to ensure a successful
transition of the drug into early clinical testing
• Should the drug enter clinical testing?
• What pre-clinical data will optimise the success of the early clinical plan?
• Where should I conduct my first in man study?