Controversy around Suicidality Monitoring in CNS Clinical Trials

Nov. 24, 2010 - PRLog -- The absence of suicidality monitoring in previous clinical trials has lead to a number of controversies beyond those surrounding Prozac. There has been continued discussion of a link between antiepileptic drugs, psychiatric adverse effects and suicidal behaviour. In 2008 questions arose as to the existence of a link between the asthma and allergy drugs Singulair, Accolate, Zyflo, or Zyflo CR; behaviour/mood changes; and suicidality.

In its guidelines the FDA lists the following types of drugs as prospects for suicidality monitoring: weight loss and smoking cessation; isotretinoin and other tretinoins, reserpine, beta blockers and any drug being developed for a psychiatric condition.

Other key topics to be discussed include:
•   The use of biomarkers in driving CNS therapies through the clinical phases
•   Using new clinical trials design models to increase the rate of clinical success
•   Combating patient attrition when working with mentally handicapped participants
•   Effective use of Biomarkers in determining efficacy, patient populations and clinical dose
Among the experts present at the CNS event you will meet:

•Gvido Cebers,  Principal Scientist at Global Safety Assessment, AstraZeneca
•Joakim Tedroff, Head of Clinical Science, NeuroSearch
•Karl Broich, Department Head, BfArM
•Jeppe Klint Buchbjerg, Clinical Pharmacology Scientist, Lundbeck

Optimising Clinical Development in CNS is co-located with Optimising Clinical Development in Oncology  as a part of Clinical Trials Summit. To see the final speaker line-up, please visit www.clinicalcns.com or www.oncologysummit.co.uk