Schneider et al10 applied these criteria to a large, state -wide selleck compound database in California and excluded all but 10% of patients. The resulting sample was younger, less severely ill, more highly educated, and more likely to be white and with higher incomes than the population as a whole. These sorts of data provide little new guidance to the patient, family, or clinician in the selection of treatment approaches. In fact, there is
a small but growing literature on issues relating to subject selection in clinical trials.11 In schizophrenia, for example, subjects tend to be younger than the general clinical population and are Inhibitors,research,lifescience,medical more likely to be male and part of an ethnic minority.12 In the Treatment Strategies in Schizophrenia (TSS) study, fewer than 10% of those screened were actually enrolled in the study12 The story is much the same in bipolar illness. In general, subjects enrolled in studies tend to have been ill for a very long time – 15 years in bipolar trials13 – and are unstable or unsatisfied Inhibitors,research,lifescience,medical with their current treatment. Even in studies attempting to recruit first-episode
patients, the period of undetected or untreated illness exceeds 3 years.14 Age itself is a common concern, with many studies having Inhibitors,research,lifescience,medical an arbitrary age cutoff of 55 or 60 years. Even “geriatric” studies have been restricted, for all intents and purposes, to the “young-old” population of patients in their sixties. Few older patients have ever been studied,15 despite the clear impact of advanced age on pharmacokinetics, dynamics, and drug metabolism16 and on treatment response.17 Inhibitors,research,lifescience,medical In general, the rigid exclusions of most regulatory-oriented clinical trials have significantly Inhibitors,research,lifescience,medical distorted the conclusions of these studies. Public health model intervention studies Studies that are informed by a public
health model are often, called “effectiveness” studies. We avoid use of that term, since it seems to convey multiple and conflicting meanings in different audiences. Public health studies bring us into the world of actual practice with time-pressured clinicians taking care of large numbers of patients Carfilzomib with uncertain clinical presentations, complex comorbidities, and varying degrees of interference with ideal levels of compliance. The exclusive focus on symptomatology is expanded to include outcomes related to issues of function, disability, morbidity, mortality, resource use, and quality of life. The classic public health trial is used to assess the expected outcome under usual circumstances of practice.18 In contrast to the elegantly crafted efficacy trial, a public health trial must be bigger in size, simpler in design, broader in terms of inclusions and narrower in terms of exclusions, and more representative with respect to settings of care.