In writing up your report please carefully read the instructions for the assignment. To reiterate keep in mind the following i) you can base your study on existing designs/studies (published or detailed in some clinical trial repository such as [login to view URL]) as long as you clearly attribute/cite them ii) remember you can use investigational drugs or drugs that have a potential off-label (i.e. not clinically approved for the use/effect that you have detailed in your primary/secondary outcome measures) iii) in all cases you will need to justify ALL aspects of the study design including why you chose specific primary and secondary outcome measures, the experimental design, study cohort demographics, inclusion and exclusion criteria and data analysis methods
Length: 2000 words excluding references
You are to construct a simple study to address a specific question regarding the cognitive effect of an existing investigational product. As background you will need to refer to the early material presented in tutorials and lectures on basic neuropharmacology, neuroimaging in psychopharmacology, cognitive assessment and clinical trial design.
1. Choose an investigational drug: An investigational drug may be either a drug currently in development or being trialled (typically Phase II or III) or it may correspond to an already existing pharmaceutical agent that is being investigated for “off-label” (i.e. unapproved) clinical use (e.g. ketamine in depression). A good place to start for a list of investigational drugs is [login to view URL] (Pharmaceutical Research and Manufacturers of America – Medicines in Development).
2. Specify, and justify, a primary outcome measure i.e. an outcome that the investigator considers to be the most relevant and important among the possibly many outcomes that could be measured. Make sure the primary outcome measure is assessing some aspect of cognition or behaviour.
3. Detail a proposed design, and justify, considering the strengths and weaknesses of the methods used. In particular you will need to include:
a. An overview of the design
b. Study population size and constitution (gender, age)
c. Study inclusion and exclusion criteria relevant to the investigational drug being studied
d. Methods utilised to measure drug effect (neuroimaging, biochemical tests, cognitive and behavioural assessments)
4. In writing up your study ensure it is well organized into sections with appropriate headings. One example might be:
a. Overview of investigational drug and its potential clinical utility
b. Investigational hypothesis regarding specific clinical effect (this is where you would detail your primary and secondary outcome measures)
c. Overview of proposed study design
i. Study population
ii. Study inclusion and exclusion criteria
iii. Study design
iv. Data collection/acquisition
v. Data analysis
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