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Post-marketing studies are sometimes requested by the FDA as a condition of drug approval, and often relate to the clarification of safety and efficacy questions. Best Practice is well-positioned to assist companies to address post-marketing conditions set by the Agency.
Investigator Initiated Post Marketing Studies have helped to transform clinical practice in neurology and psychiatry, improving the care of patients and expanding the market potential of approved drugs. Early in the post-marketing period, companies are usually interested in obtaining the additional indication, and will support registration trials in order to obtain FDA approval. Later in the post-marketing period, companies may be less likely to apply for the additional indication, with the knowledge that the investigator-initiated research may increase off-label prescribing for the marketed drug. Off label prescribing is particularly common in pediatric and geriatric populations in psychiatry (as in the rest of medicine).
While the FDA considers off-label prescribing to be a part of the practice of medicine, the Agency has become concerned about the appearance of marketing off-label indications. As off-label prescribing has come under increased scrutiny by regulators, physicians, the media and the public, it has become important for companies to draw clear distinctions between sponsored research and marketing activities.
The leaders of Best Practice, and their distinguished panels of experts across neuro-psychopharmacology, have extensive experience in designing and implementing a full range of post-marketing research in psychiatry and neurology. In the context of the new regulatory and media environment Best Practice helps companies design and implement well designed, rigorously conducted research with the results submitted for publication in major peer-reviewed journals.
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