In general, post-marketing safety / effectiveness studies (for drugs and/or medical devices) do not appear to be undertaken systematically or promptly. Even when regulators specifically require the license holders to do them, the evidence is that they are often done slowly or not at all & if done, the results are exceedingly hard to find. Some systematic & timely methods of surveillance are needed, especially as regulatory evaluation times shorten & surrogate outcomes are used - how? - whose responsibility?
I think it would be fair to share the responsibilities to both ends, the regulators and the license holders have varying part to play. More often than not, regulators are filled with a back log, and this would slow down proper perusal for the license holders. A more systemic approach should be designed to help improve communication channels and help ensure deadlines are met for the holders. My 2 cents on the mater.
As you said: most of the time they are not done at all.The best method beside encouraging compliance to regulations is to establish an effective tracking system between physicans and license holders. Training courses can help, using social netwrok to increase the awaress about this issue might help, too.
I totally agree with Isra Dmour. Public enlightenment is key, creating a central channel where access to data can be cited by the public will allow bigger discourse and help improve several dynamics in the process. Regulators and holders should establish better communication channel and transparency. This is where the key issue of accountability comes in and how much we can quantify such process.
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