title: Assuring the safety and effectiveness of new drugs: rigorous phase IV trials randomizing general practices to delayed access to new drugs.
abstract: Randomized trials are crucial for establishing the effectiveness of new drugs and procedures. However, they are less effective at detecting uncommon but clinically significant side effects. We propose a solution. All UK general practices could be randomized to be allowed to prescribe new licenced drugs earlier or later. This would produce a large pragmatic cluster trial which could enable rare, but harmful, effects to be demonstrated more quickly than the current usual practice of looking for harmful events in observational datasets. Given current computerization of practice records such an approach is feasible and likely to be cost-effective.
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, York, UK.
authors.forename: Joy
authors.initials: J
authors.lastname: Adamson
authors.forename: Tjeerd
authors.initials: T
authors.lastname: van Staa
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
mesh_terms: D017327:Clinical Trials, Phase IV as Topic; D017277:Drug Approval / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D058006:General Practice; D006297:Health Services Accessibility; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D006113:United Kingdom