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Innovative Designs of Controlled Clinical Trials in Epilepsy

Innovative Designs of Controlled Clinical Trials in Epilepsy,10.1111/j.1528-1157.1993.tb04589.x,Epilepsia,Lennart Gram,Dieter Schmidt

Innovative Designs of Controlled Clinical Trials in Epilepsy   (Citations: 12)
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Journal: Epilepsia , vol. 34, no. s7, pp. S1-S6, 1993
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    • ...These protocols have been increasingly used in the last few years, to the extent that their introduction can be considered as a revolutionary step in antiepileptic drugs’ evaluation [4]...
    • ...While the above studies provided invaluable information for a rational use of antiepileptic drugs, application of this type of design to the monotherapy evaluation of new drugs has raised major problems with some regulatory authorities, most notably the US Food and Drug Administration [4]...
    • ...EÅcacy end-points in these trials may be similar to those described for presurgical protocols, and provisions can be made for longer-term evaluation of patients who responded well to the allocated treatment [4]...
    • ...While over the last few years innovative protocols may have served a useful function in providing a stimulus to epilepsy research and to heated discussions on trial methods [3, 4, 17], the need to improve eÅciency in monotherapy evaluation may have led the pendulum to swing too far away from the needs of patients and physicians...

    E. Perucca. Innovative monotherapy trial designs for the assessment of antiepilept...

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