PRAC Review Cycles
- 99 new protocols evaluated from July 2012 to July 2014 (26 imposed): Overal 150 protocols reviewed
- After one year of meetings, average of 15 protocols evaluated per month
- Median 2 rounds of review for imposed, and 1 round for non imposed
Imposed/ Mandated PASS
- 26 protocols (7 protocols with no info available)
- 58% were rejected due to an inadequate proposed study design to meet the study objectives
- 42% (n=8) were endorsed at the first round of review pending further clarifications on a list of questions
Non-Impossed/ Voluntary PASS
-
73 protocols (9 protocols with no info available)
70% (n = 45) were endorsed at the first round of review pending further clarifications on list of questions - 30% had revision due to
- Sample size
- Statistical analyses
- Missing timelines
- Enrolment strategy
- Representativeness
- Bias and confounding
- Observational nature of the study an inadequate proposed study design to meet the study objectives
The EU PASS Register
- 35% of imposed and 23% of non imposed studies are registered
- Overall one out three PASS are registered with an slightly higher proportion for imposed as compared to non imposed