Innovative designs
8 important questions on Innovative designs
What are innovative study designs? (2)
- Address a number of research questions onder one administrative trial.
- Most effective way
Why is there a need for innovative trials?
- Precise medicine => more drugs and groups (narrow population) => need for other trials => quicker.
- A lot of new medication
- More tested at the same time => higher likelihood of succes
- More affordable
What is the balance in innovative studies?
As much as complex as possible to have the most benefit.
- Higher grades + faster learning
- Never study anything twice
- 100% sure, 100% understanding
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What are disadvantages of a basket trial?
- Difficult statistical properties => potential misuse
- Potential bias => you have to take into account a lot of factors.
- Higher risk of false positives.
- Your groups should be not too small.
What are advantages and limitations of an umbrella trial?
Con:
- It takes time to identify multiple drug targets. => slow progress
- Lots of stakeholders
- Complex data analysis
- You can extent the trial to a platform trial
- You have one disease, so your patient population is not really heterogene => less heterogeneity = generalizable.
What is a platform trial?
“To study multiple targeted therapies in the context of a single disease in a perpetual manner, with therapies allowed to enter or leave the platform on the basis of a decision algorithm”
=> You do lots of interim analysis.
Which innovative trial needs the highest sample sizes?
Middle = umbrella (multiple treatments multiple, safety and efficacy tests)
High = platform
What are consequences of using a master protocol?
- First approval will take longer
- You add appendices that can change.
- If your population changes you can change the appendices
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
