Mental health professionals discovered, discussed, and, largely, embraced the use of RCTs. Up to the advent of antipsychotic drugs such

as chlorpromazine, psychiatric care had been likened to “little more than zoo keeping”5 and, perhaps because of that stinging criticism, those undertaking the trials did not necessarily follow the path of that first tuberculosis trial. Factors Inhibitors,research,lifescience,medical combined to largely direct mental health trials along another route. There was the yearning for rigorous science, collective subspecialty insecurity, and also the needs of regulatory authorities. Mental health trials drifted towards use of as rigorous diagnoses as possible, rather rigid regimens of care and use of fine-grained outcome measures that, are not usually part of routine practice. This planted the RCT firmly in the realm of researchers, and Inhibitors,research,lifescience,medical there it has stayed. The needs of regulatory GSK458 molecular weight authorities did have to be met, but, there was less consideration of needs of clinicians and of recipients of care and their families. This was not at all unique to mental health, but it. took leaders in the fields of cancer care,6 heart disease,7 and perinatal medicine8 to recall and

Inhibitors,research,lifescience,medical refine the techniques of generous inclusion, simple treatment, and routine data collection that underpinned the MRC trial of 1948. Many examples now exist in these areas of RCTs where entry criteria are broad and encompass as many relevant people as possible, the treatment Inhibitors,research,lifescience,medical packages are those that would be given in everyday care, and outcomes are essentially routinely recorded data. Examples of such open work were rare in mental health until relatively recently. The description of “pragmatic” or “practical” is increasingly employed of trials in psychiatry or psychology but there are clearly different interpretations of what, this really means. A recent series of papers has highlighted Inhibitors,research,lifescience,medical the problems in interpretation of the explanatory/pragmatic domains in trials and presented some practical solutions.9 It is not a simple continuum from explanatory through to pragmatic. There are

many elements of design that should be considered to allow a judgment to take place about whether a randomized trial is investigating whether, in ideal circumstances, a treatment could work (explanatory) or, at the other extreme, whether this accessible treatment would work in everyday practice (pragmatic). This is second not a purely academic exercise. There are good reasons to make these judgments. To use one example, funders, on receiving a proposal, may wish to consider whether the proposed trial fits with the ethos in which that support was proffered. For example one funding body may be interested in discovering potentially new treatments. In this instance, explanatory studies, undertaken in very rigorous circumstances with fine measures of outcome to highlight, any – even modest, – effects, may be best.