PQR,
I believe that much of the reason for the cost and complexity of clinical trials involves the lack of trust between the FDA and the drug makers. If simpler, cheaper trials were established, but all approvals were followed by a Phase 4, the effectiveness, or flaws in drugs, would be exposed. If the FDA saw problems, they could act. Doctors and patients could look at the Phase 4 database to see how existing patients are reacting, but only the Dr. and patient could put information in the Phase 4 database. Doctors and patients name would not be revealed.
Companies couldn't hide adverse reactions by paying off people under confidentiality, all results, including off label use would be identified. Other Doctors and patients could see that say DCVax-L had been used for a breast, or lung cancer patient, they could view the outcome based on the review of the prescribing Dr. and patient. Anecdotal evidence of efficacy could build up rapidly for off label use as each use would describe what it was being used for, and other drugs it was being used with for the condition being treated. The database would hide the name of the Dr. and patient, but both would be able to add to the information in the database.
The Phase 4 would continue for at least a few years, after which time it would be up to the regulator to declare it no longer being necessary, or it might be determined that keeping it in place would be wise as it could be done with little cost or time. This should eliminate the lack of trust between drug developers and the regulators as nothing could be hidden by payoffs, and non-disclosure agreements.
Gary
News 
Market Data 
Discover 
