What is the protocol and what is included in it? (11)
Set of instructions to carry out experimental procedure to address primary research question
Will need to be submitted for regulatory or ethics committee review to look at
Includes:
- Background
- Objectives and research question
- Design
- Intervention
- Follow up visits and schedules
- Safety assessment
- Data analysis
- End of study / termination policy
- Organisation
What is the difference between superiority and non- inferiority trials? (4)
Superiority (Comparative trial):
To demonstrate if IMP is superior to standard treatment in terms of outcome measures
H0= 2 treatments have same effect
Equivalence (Non inferiority trial)
To demonstrate if X is no worse than standard treatment in terms of outcome measured
H0= 2 treatments are different
When may a non- inferiority trial be used? (3)
- Bioequivalence trial in development of generic drugs
- New treatment has important advantages over standard treatment
- When testing new treatment against placebo is unethical
What is a factorial design clinical trial? (1)
When participants are randomised to more than 2 treatments or there are many independent variables
(Eg: 2x2)
How can the participant and investigator prevent missing data and maximise protocol adherence? (6)
Investigator:
- Simpler case report forms
- Reduce unnecessary collection of datapoints
- Training and re- training
Participant:
- Reminder to attend visits
- Reminder and training for trial assessments, such as adherence to treatment
- Set rules to exclude patients when non- adherent
How might a clinical trial practitioner minimise variation? (4)
- Consistent endpoint measures
- Objective endpoint measured
Such as same machine, technicians, imaging assessments, standardised trial procedures - Adverse events reporting
