Similarly, many studies have long no-treatment periods for observ

Similarly, many studies have long no-treatment periods for observation and diagnostic purposes. Clinicians are not likely to withhold treatment from severely ill patients in whom immediate treatment is seen as an absolute necessity. Thus, only those patients who can tolerate a long no-treatment period are sellekchem recruited. These patients are likely to be less severely ill. It has long been observed Inhibitors,research,lifescience,medical that severity and placebo response are inversely related. If advertising is used as the primary source of recruitment, a group of high-likelihood placebo responders, the “worried well,” arc often the ones recruited. If, on the other hand, the recruitment is largely from product information active clinic or

practice populations, there is likely to be preferential treatment of nonresponders under the justification that it

is inappropriate to “rock the boat” for patients that are doing well by switching to a new treatment. Study operations In large, multiple-site studies, recruitment is often set as a horse-race with enrollment Inhibitors,research,lifescience,medical concluded when the overall study sample is achieved. Payment to sites is largely on a per-patient basis. Therefore, as the study recruitment goal appears closer, there is a financial incentive to enroll subjects Inhibitors,research,lifescience,medical while enrollment is still possible. Over time, that could lead to a drift in criteria: mild symptoms are seen as more serious, and borderline eligibility gets to be considered acceptable. This erosion of severity promotes placebo responder recruitment. In combination treatment

studies, operational concerns minimize differences between pharmacological and Inhibitors,research,lifescience,medical psychosocial treatments. Typically, the approach to pharmacotherapy is rigid with fixed dosing and short duration – an approach uncharacteristic of clinical practice. Clinicians in the pharmacotherapy arm must behave robotically and in a manner unlike the way they generally work. Training and supervision are minimal. Those doing the psychosocial treatment, on the other Inhibitors,research,lifescience,medical hand, are typically highly selected, well-paid, well-trained, and closely supervised. We therefore commonly encounter trials in which expertly done psychotherapy beats poorly done pharmacotherapy, and cannot separate the operational aspects from the true clinical effect of the different treatment approaches. Outcome measures In psychiatry trials in general, Batimastat and in depression trials in particular, there is a tradition of using too many measures, most of which are rating scales or self-report forms of dubious validity and notorious unreliability. Measures are selected because they have worked in the past, and are therefore uninformed by contemporary science and knowledge of etiology or pathophysiology. There are few examples of composite, event-based measures, such as are typically used in cardiovascular trials (major adverse cardiac events, MACE), in mental health. We need to have more.

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