Figure 1

Publication strategy versus indication strategy. A publication strategy consisted of conducting clinical trials with an objective of disseminating results and generating clinical use of the drug for an unapproved indication, as opposed to obtaining FDA approval for marketing (that is, an indication strategy). The figure is a snapshot of a “marketing assessment” of gabapentin for migraine prophylaxis illustrating recommendation of a publication strategy that consisted of conducting trials to disseminate results and generating clinical use of the drug for an unapproved indication instead of obtaining FDA approval (that is, an indication strategy). Excerpted from Pfizer_JMarino_0001611 [28].