Specific measures are taken to ensure compliance of the clinician with the protocol and adherence of the patient with the procedures and treatments. Formally, GDC-0994 manufacturer efficacy studies define optimal treatment outcomes for narrowly selected patients treated under rigidly controlled and ideal conditions. With a primary focus on symptoms, the assessment of efficacy is based upon the degree to which the level of symptomatology is reduced or eliminated.6,7
Inhibitors,research,lifescience,medical In an efficacy trial, treatment is provided by specially selected and trained clinicians who provide optimal treatment and expend substantial resources to ensure compliance and minimize drop out. Research supported for commercial purposes, particularly that supported by the drug companies themselves, has, of necessity, conformed to the regulatory model. This is the case regardless of whether the site of the study is an academic health center or a community- treatment facility, and regardless of whether the coordination of the study Inhibitors,research,lifescience,medical is done directly by the sponsor or by an intermediary (contract research organization,
or CRO). It is worth noting that those doing clinical Inhibitors,research,lifescience,medical psychotherapeutic or behavioral research have not (yet) adopted this CRO type of arrangement. The regulator)- model has also been carried over into research that has no industrial sponsorship, even to research on mental disorders that has been directed to government Inhibitors,research,lifescience,medical agencies or foundations. In a treatment study driven by a regulatory model of investigation, there is no minimum effect size or minimum pro portion of rcsponders necessary. In addition,
there is no requirement that the subject population be representative of the kind of patient seen in actual practice. As such, a trial done in accordance with the regulatory model represents only the beginning of a process of clinical development. Inhibitors,research,lifescience,medical Efficacy studies define optimal treatment outcomes for narrowly selected patients treated under rigidly controlled and ideal conditions. The Calpain classic efficacy trial is used to define the gold standard of the best outcome under ideal circumstances. Because of the tight standard of control required in efficacy studies, the policy and practice relevance of these trials will always be limited.8 The clinical trials of cognitive enhancers provide a useful example of the differences between regulatory and public health research. The trials of cognitive enhancers seek to show slowing or reversal of the progression of Alzheimer’s disease or to demonstrate improved management of the symptoms of the disease. These trials typically attempt to show that the course of a progressive disease has been modified. The design of such trials involves great complexities even under optimal conditions.