16th Annual Meeting Abstract: Unresolved problems in neuroscience drug development
– Drugs with abuse potential: Should they be used to treat psychiatric disorders?
Chair: Walter Dunn MD, PhD
This session will explore the use of drugs with abuse liability in the treatment of psychiatric disorders. Several drugs with abuse potential have recently been approved or are in late stages of clinical development. These drugs with their unique mechanisms of action offer novel approaches for treatment resistant conditions. However, the potential for addiction and withdrawal demand a more careful calculus of their use. Speakers will discuss the methodological challenges facing clinical development of these drugs. Issues of functional unblinding, drug withdrawal effects, and off-label prescribing will also be discussed. A perspective from addiction psychiatry will also be presented.
– Are current digital measures ready for prime time?
Chair: Philip Harvey PhD
Technology based assessments are becoming more widely used. As their use increases, they are also increasingly more likely to be considered as outcomes measures in clinical trials. Regulators agree with the use of technology-based outcomes assessments, but also want to maintain the same level of validity and sensitivity standards applied to traditional outcomes measures. If technology-based outcomes assessments are ever to replace traditional measures, they will need to demonstrate their equivalence.
In this session, the extent to which current technology-based outcomes assessments could be used as outcomes measures in clinical trials will be the focus of discussion. An academic research scientist and a regulatory specialist from the US FDA will lead this discussion with a focus on what the nature of current regulatory standards and how current potential outcomes assessments meet those standards. Areas where standards may be met and areas in need of more data will be identified and discussed.