A more radical solution.
The current modifications to licensing procedures still leave a basically flawed system in place. A more radical solution is proposed that involves dispensing with Phase 3 trials and making medicines available at the end of Phase 2 to those who are fully informed of the potential risks and benefits and wish to take part in this novel procedure. The advantages include a shorter development time, lower development costs and allowing smaller companies to take medicines to the clinic. The principal obstacle is that medicines are subject to strict liability rather than the tort of negligence - and this will have to be amended in due course.
Department of Veterinary Medicine, University of Cambridge, Madingley Road, Cambridge, CB3 0ES, United Kingdom. pjl1000@cam.ac.uk.
Peter J
PJ
Lachmann
D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006801:Humans; D016365:Liability, Legal; D006113:United Kingdom
D015507:Drugs, Investigational