Minimising Harm by Careful Study Design

Clinical research is subject to legislation in which informed consent (see below 7.2.3) and the evaluation by a medical ethics committee play critical roles in establishing which procedures may be undertaken. This is no different for the new types of brain intervention that were reviewed in this study. However, the particular risk of them causing subtle mental side effects means that special care must be taken in designing studies. Not only should clinical trials not be performed when interpretable and meaningful results cannot be obtained (such trials would, in fact, be unethical). In addition, the significance of obtained data will be higher if a standard protocol for the essential symptom measures of brain anomalies is used. The number of patients subjected to experimental interventions in the CNS could be minimised if such standard or core evaluation protocols were available. This leads us to the following recommendation:

^ For experimental interventions in patients with neurological and psychiatric disorders, time-scheduled and disease-specific core assessment protocols (CAPs) should be established in order to (1) obtain meaningful results and (2) enable comparisons between different treatment approaches.

As for every neurological or psychiatric brain disorder a specific CAP will be needed, these protocols are themselves subject to research and agreement amongst the scientists and clinicians who specialise on a particular brain syndrome. Thus, this recommendation is addressed above all at researchers, rather than legislators. It favours, however, multi-centre collaborations in clinical studies on specific interventions as is currently the case in the field of pharmacology.

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Brain Blaster

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