Pharmacy Related Research

Question 1

What are the study types used in pharmacy research? Provide THREE.

Answer 1

1. Lab-based research (optimising existing drug therapy, drug formulation, stability,)
2. Clinical trials
3. Pharmacy Practice and Clinical Pharmacy Research

Question 2

Explain what the four phases of the clinical trials are and their aims/focuses.

Answer 2

Phase I

• 1st administration of medicine to humans, usually small numbers of healthy volunteers (20-80s)
• focus: safety, MOA, tolerability, route of admin, dose range

Phase II

• 1st trials of the medicine in ‘patients’ –> small numbers of closely monitored patients (100s)
• aim: to determine effectiveness and safety

Phase III

• Involve greater number of patients
• Determine clinical benefits, side effects

Phase IV

• Post-approval –> determine role in therapy
• Post-marketing surveillance in normal clinical setting

Question 3

For Phase III trials, define the following terms;

A) Superiority trial (superiximab and the alternative)

B) Equivalence trial (superiximab and the alternative)

C) Non-inferiority trial (superiximab and the alternative)

Answer 3

A)

• Is superiximab better than the alternative (either the current gold standard or placebo)

B)

• Is there no significant difference between superiximab and the alternative (i.e. it is no better or worse)

C)

• Is superiximab no worse than the alternative?

> same efficacy but better AE profile or dosage regimen

Question 4

What are examples of observational and intervention studies used in pharmacy practice + clinical pharmacy?

Answer 4

Observational

• Descriptive (retrospective, prospective)
• Epidemiological studies (pharmacoepidemiological)

Intervention –> implement change then evaluate

• Experimental –> randomisation
• Quasi-experimental –> no randomisation

Question 5

What are the examples of other studies used in pharmacy practice and clinical pharmacy?

Answer 5

• qualitative research
• mixed methods
• pharmacoeconomics
• systematic review + meta-analysis