By Bernard Ravina; et al
''Translating laboratory discoveries into winning therapeutics should be tricky. scientific Trials in Neurology goals to enhance the potency of medical trials and the improvement of interventions so that it will increase the improvement of latest remedies for neurologic ailments. It introduces the reader to the main options underpinning trials within the neurosciences. This quantity tackles the demanding situations of developing remedies for neurologic issues from dimension of brokers within the apprehensive procedure to the development of medical signs via illustrating particular examine designs and their functions to varied healing components. medical Trials in Neurology covers key matters in section I, II and III medical trials, in addition to post-marketing safeguard surveillance. subject matters addressed contain regulatory and implementation concerns, end result measures and customary difficulties in drug improvement. Written by way of a multidisciplinary group, this accomplished advisor is vital interpreting for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and medical researchers within the pharmaceutical industry''-- Read more...
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Additional info for Clinical trials in neurology : design, conduct, analysis
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For example, initial eicacy trials in middle stage may uncover that peripheral edema complicates the use of a medication in a signiicant percentage of patients. For any patient presenting with a complaint of edema, speciic additional medical history is recorded, limb measures are taken and additional blood, urine or other testing is performed to more fully understand the nature of the edema in speciic cases. At the end of the late stage program, these data are summarized and described in aggregate and can provide signiicant insight into a particular safety or tolerability issue.
In addition, diiculties arise because of the complexity of the CNS and the challenges of developing clinical endpoints to capture therapeutic efects on multiple functional domains controlled by complex brain Chapter 3: Unique challenges in the development of therapies circuits. Some of these problems have arisen because we have historically used clinical scales that were developed to describe subgroups of domains afected by CNS diseases. One example is the EDSS in MS which is largely inluenced by lower extremity walking function, but less so by cognition or upper extremity function.
Clinical trials in neurology : design, conduct, analysis by Bernard Ravina; et al