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Epilepsy Organizations:
Antiepileptic Drug Trials Symposium For the past decade and a half, a group of individuals have been meeting on a biennial basis to discuss ways in which the process of bringing new therapies to patients can be expedited. Participants have included individuals from academia, from interested government agencies such as the Food and Drug Administration and the National Institutes of Health, as well as representatives from the pharmaceutical and device industries. The purpose of these meetings has been an exchange of ideas, discussion of roadblocks to therapeutic development, dialogue about regulatory strategies, and sharing of successful approaches. Over the years, discussions at this symposium have led to implementation of new trial designs, as well as new important analyses of trials that have already been performed. In addition, new regulatory pathways have been identified, particularly as related to approval of new antiepileptic drugs for monotherapy use. In this special issue of epilepsy research, the outcome of these discussions is made available to the general research community. It is hoped that this information will be useful to individuals who are interested in the therapeutic development process. In addition, it will be useful to clinicians who ultimately use these therapies, as it will provide an understanding of clinical trial methodology and analysis. Information and program for the next meeting which will be held March, 2009 will be provided shortly. BRANY Several of the clinical sites have the option of using the Biomedical Research Alliance of New York (BRANY) for contracts and IRB submissions. For more information on BRANY, please see www.BRANY.com. |
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