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[Are phase II or phase II antidepressive drug studies still feasible considering currently required inclusion and
T Steckler1, K Hosten, B Müller-Oerlinghausen
1Psychiatrische Klinik und Poliklinik, Freien Universität Berlin.
Abstract:
The present policy of pharmaceutical companies to aim at perfectionistic, and therefore inflexible protocols for clinical drug-trials renders patient recruitment increasingly difficult or even impossible, and may result in an increasing number of non-completed studies. It appears that many of today's inclusion and exclusion criteria are not sufficiently assessed in terms of their scientific basis and clinical usefulness. Sense and nonsense of these criteria are discussed. The tendency to adhere to streamlined protocols to certify the needs of drug regulators will severely impair the feasibility and validity of antidepressant drug trials in psychiatric in-patients.