Reading for 9/26

Three Interesting Things:

1.) I find it interesting that if a drug is trying to be imported into the U.S. from an outside country, they can try to get around requirements of the FDA by filing for an IND. Sometimes drugs need to be imported in order to complete trials or studies but the FDA has a lengthy list of requirements and protocols to do so in terms of labeling, naming, and formula but if an IND is filed then they can get around these aspects in order to expedite the process.

2.) The advance in technology that we have been touching on for the last three weeks is coming up again. We have talked about how it is taking jobs away from professionals in order to improve the industry's efficiency as a whole. This reading talked about how RWD is improving the system drastically in terms of electronic data and systems to provide the data so that it is being compiled faster and in high volumes in order to improve trials.

3.) Finally I think that it is interesting that the 21st Century Cures Act is being based on the idea of using RWD/RWE regularly in trials because it offers more practical data that propels the trial faster. When it was found that using RWD/RWE can drastically improve a trial, now it is sort of mandatory to be used in order to heighten the industry. This relates to the usage of CTMS since their system like Medidata base their work off of RWD/RWE.

Three Questions:

1.) What are A of C codes?

2.) Is RWD/RWE used pre-trial or along the journey of it?

3.) Is there a more advantageous usage of RWD/RWE in efforts to better the consumer business model rather than just the clinical trial?

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