@entity3949 is a chronic progressive disease accounting for considerable morbidity and reduced quality of life among @entity1 with @entity6 . Accumulating evidence suggests that the clinical and neurophysiological markers used to assess @entity16 not only predict the development of @entity1411 , one of the most common causes for hospital admission and lower limb amputations, but are also predictors of increased mortality in @entity6 @entity1 . In addition to metabolic control, drug treatment of both incipient and clinically manifest @entity3949 will be necessary for the years to come. Because 1-2% of the whole population in western societies may be affected, the search for effective drug treatment is not only a very important goal for the @entity1 suffering from @entity3949 and for the practicing physician, but also an economic task for both the health care systems and pharmaceutical companies. The validity of inferences about the clinical consequences of the use of any given agent to induce a specific pharmacologic effect will depend not only on the extent to which it affects the targeted biological phenomenon, but also on the extent to which all of the actions of the agent have been defined and the extent to which all affect the entire organism, alone and in concert. The ultimate test of the usefulness of a drug or device depends on the determination of outcomes, ideally in @entity922 ( @entity922 ) of sufficient scope and duration. The efficacy and safety of a variety of drugs based on the different pathogenetic hypotheses proposed have been evaluated in @entity922 since the 1970s. However, the quality of @entity922 published between 1981 and 1992 that evaluated the effects of medical treatment in @entity6 was poor. Adequate designs for @entity3949 must consider the following criteria: type and stage of @entity16 , homogeneity of the study population, outcome measures (neurophysiological markers, intermediate clinical end points, ultimate clinical outcomes, quality of life), natural history, sample size, study duration, reproducibility of neurophysiological and intermediate end points, nonspecific effects of treatment, measures of treatment effect, the extent to which the overall trail result applies to individual @entity1 (external validity), and the reporting of the @entity922 . Trials focusing preferentially on @entity1 with mild or moderate early stages of @entity16 over long periods of 3-5 years aimed at slowing or prevention, rather than reversal, using end point measures that have clinical and prognostic significance are most likely to produce meaningful results.

Clinical trials for drugs against XXXX : can we combine scientific needs with clinical practicalities?

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetic', 'diabetic polneuropathy', 'diabetes'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neuropathy'] @entity3949 :: ('MESH:D003929', 'Disease') :: ['diabetic neuropathy', 'RCTs in diabetic neuropathy', 'Diabetic neuropathy'] @entity1411 :: ('MESH:D016523', 'Disease') :: ['neuropathic foot ulceration'] @entity922 :: ('MESH:D013568', 'Disease') :: ['randomized clinical trials', 'RCTs']
@entity3949 :: (MESH:D003929,Disease) :: ['diabetic neuropathy']
