Clinical Trial Design Flashcards
1
Q
Discuss the uses of the clinical study.
A
- Provide evidence
- Test efficacy
- Test safety
2
Q
Discuss the basic considerations involved in trial design.
A
- Time scale
- End points (Death, no, of hospital admissions, desired effect)
- Choice of control drug (placebo, actual drug)
- Choice of patients (age, race, compliance)
- Exclusion criteria (pregnant women, children, elderly, seriously ill patients)
- Drugs used (formulation, dose, frequency)
3
Q
Single blind trial:
A
Doctor knows which drug, patient does not know.
4
Q
Double blind trial:
A
Neither the doctor, nor the patient knows.
5
Q
Randomised:
A
Patients are assigned to a group at random to prevent bias.
6
Q
Placebo controlled:
A
In a group of 100 patients, 50 get the placebo and the rest get the active drug and comparisons are made at the end
7
Q
What is involved in pre clinical development?
A
- Animal pharmacology
- Animal toxicology
- Tissue culture
- Phase 0
8
Q
Describe phase I of clinical development.
A
- New treatment is tested in around 100 normal volunteers
- Generation of pharmacokinetic and pharmacodynamic data
- Certain drugs such as cytotoxins bypass the phase
9
Q
Describe phase II of clinical development.
A
- Involves up to 500 patients
- Clinical investigations to confirm kinetics and dynamics in patients
- Provides some evidence of efficacy and identifies a likely dosage range
10
Q
Describe phase III of clinical development.
A
- Involves 1000 - 3000 patients
- Comparison of standard treatment vs new treatment
- At completion, all data is submitted as an application to the regulatory authority for a license to sell the drug
11
Q
Describe phase IV of clinical development
A
- May involve tens or hundreds of thousands of patients world wide
- Post-marketing surveillance to produce evidence of long term safety
12
Q
Prospective trial:
A
Protocol decided before hand
