Please write a 2000-word essay on the topic below: During your research, you have identified a gene which you hypothesis is involved in promoting cancer. Firstly, describe how you could confirm this role including model systems that you could use to generate strong per-clinical data. Assuming, based on the clinical data generated, that your hypothesis is correct describe the clinical trials (Phase 1-3) that you would carry out to determine the effects in humans of a hypothetical new drug targeting this gene, that has not previously been tested in humans, with reference to (a) clinical efficacy and (b) potential side effects. Factors to bear in mind… · How could you ensure that the model systems used to generate the per-clinical data were relevant to the clinical situation? · How would you validate the gene’s functional role in those models? · How would you determine that it was effective in humans? · How might you demonstrate its mechanism of action in humans? · What are its likely side effects, and how will you monitor for them? N.B. By selecting a specific gene to target in one type of cancer, it will be easier to define how you will measure efficacy and side effects in clinical models and patients. • Good answers generally – are logically argued – make good use of examples – use diagrams where appropriate – include references Generic answers will receive a lower mark Answer both parts : introduce your gene target > clinical work > clinical trial I have attached the full essay description, mark schemes and example essay below:
