Please answer to the following question. The answer should be 1 typed page minimum, references excluded (maximum possible points=100). The answer will be graded based on ideas and concepts presented and how clearly concepts are explained. You read the paper “PIIS0016508514003047” posted on blackboard for some hints on hepatitis C treatment.
Design a clinical trial to test a new treatment for hepatitis C patients. The essay shall include:
1) Description of hepatitis C infection and treatment challenges.
2) A treatment you propose in order to overcome an unresolved treatment challenge. Description of molecular mechanism of the selected treatment and scientific evidence justifying the use in humans.
3) Planned enrollment (depending of what phase clinical trial you chose, state the planned number of patients, eligibility – who can participate: childbearing age women, minors, etc. Phase IV not acceptable).
4) Description of necessary documents in order to meet the current ethical guidelines for clinical trials.
5) Description of surrogate markers that will be measured to quantify the outcome of the trial. Description of specimen collected and how they will be analyzed.
6) Discussion and future directions.