Clinical trials Flashcards
Describe phase 1 clinical trials
Healthy volunteers
Small sample size
Adverse side effects & tolerability (safety not efficacy)
Pharmacokinetics
Tolerance (MTD, NOEL, MABEL)
SAD analysed before MAD
Describe phase 2 clinical trials
People with disease
Small sample size
Pharmacokinetics
Efficacy
Safety
Side effect profiles
What are the four important attributes
Control groups
Random allocation
Blind measurement
Replication
Describe phase 3 clinical trial
People with disease
Large sample (multinational)
Asses efficacy in large pop
Compare similar drugs
better opportunity for side effects
What qualifications do investigators need
Principle investigator usually specialist in medicine and expertise in clinical trials
Suitable qualifications
Describe requirements for locality assessments
Venue where trial conducted must be suitably equipped for comfort and safety
Resuscitation equipment and trained personnel
Furniture suitable and comfortable
Meals provided
24 hour emergency number
Card describing participation in trial
Describe experimental protocol
Investigational drug brochure
Investigator protocol
Includes experimental work on drug from first synthesis trial
Application requires experimental design and statistical analysis information
Unethical when can’t get meaningful results
What are the 4 important design attributes
Control groups - focus on treatment effect
Random allocation to conditions - Avoids bias, Balances influences
Blind measurement - Prevent bias
Replication - controls random fluctuations
Side effects and serious adverse events (SAEs)
Incidence of minor side effects
Incidence of more serious side effects
Any reports of anaphylactic shock or severe allergic response
20 people may not detect events that occur in 200 but not significant when you are the ‘one’
Describe reporting of SAEs
Person running clinic - related to trial or not
- Any hospital admissions and any non-hospitalisation report
- must include recommendation of action
How are participants recruited
Hospital clinic
GPs
National organizations
Public advertising
Describe obtaining informed consent
possible benefit vs false hope
Realistic assessment of danger
Participant requirements
Inclusion and exclusion criteria
provisions of interpreters
Describe consent on behalf of someone else
Family member or close friend for unconscious adults
Under 16 requires parental consent for 7-15 year olds
Describe cultural issues
Every application read and approved by Maori consultation
Tissue storage and shipping overseas
Disposal of specimens (blood)
Use of stored tissue (genetic analysis)
What happens when a trial finishes
Is it ethical to withdraw a medication that has been providing benefit
is there continuing responsibility
Will withdrawing the drug increase negative effect
Should they be responsible for changing patient to alternative drug
Must be clearly stated to participants
