Wordweaver- t1_irfdo59 wrote
Wu-Tang_Hoplite t1_irff5ca wrote
This paper does not discuss duplicating clinical trials. It would most likely be unethical to try to reproduce a clinical trial based on the adverse effects you uncover. If the first study is unclear you design a new trial but you don’t try to replicate it…
Wordweaver- t1_irfgalh wrote
It discusses using real-world data to replicate the findings of RCTs, not duplicate the clinical trial. If you want exact duplications, RCTs should be done in heterogenous populations to be generalizable and things that work for one population may well be duplicated later in a different population
Wu-Tang_Hoplite t1_irfio6x wrote
The paper is trying to provide support for a standard of enabling RWE to support RCT data in the FDA process which is a good thing. You don’t usually run RCTs in heterogeneous populations. You want a heterogeneous sampling of the population you are trying to treat, but depending on where you are on the world that changes ie There are ethnic and geographic differences in CYP enzymes that will change your study (if you are from a specific. Geographic/ethnic group you get 100 mg/kg if you are from group B you get 150 mg/kg). Clinical trials are designed around a specific question. Does my study meet my primary and secondary endpoints. If yes, then it supports approval for your drug. If no, then it discourages approval based on that study. Maybe you will need to do a different RCT. This is a different premise then, for example, research done in metal organic frameworks, providing support for a new battery material. This study contains the methods the authors used to create a new material, the experiment they did to test the energy storage capacity, and the result they obtained. This is the type of research it would be beneficial to reproduce.
Wordweaver- t1_irfismg wrote
Most of the replication crisis is from RCTs in social psych
Wu-Tang_Hoplite t1_irfja0p wrote
I see the issue here. Reproducing RCTs in psychology = good idea. Reproducing RCTs in medicine = more often than not unethical (because you could design a better trial based on the previous one).
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