Contributions
Abstract: 218
Type: Oral
A major issue in trying to alter the gradient of progression in multiple sclerosis (MS) is the time and expense of phase 2 programmes, both investigator and pharma-led. There is no shortage of promising molecules and/or pathways to be explored, but each trial is likely to take at least 5 years from set-up to final result. Moreover, without a well conducted phase 2 trial, the chance at success at phase 3 is correspondingly reduced. Quicker, more efficient and different trial design structures must be found and implemented to reduce the timeline, both for drug development and non-drug intervention (eg physiotherapy).
Here I will explore some of those methods including: multi-arm, adaptive, n of 1, Simon-2-stage, and Bayesian concepts. Examples will be given, looking at previous experience, as well as what could and should be done in the future.
Disclosure: Efficacy and Mechanism Evaluation Programme (NIHR), UK Multiple Sclerosis Society, University College London Hospitals/UCL Biomedical Research Centres funding scheme. Local principal investigator for trials in multiple sclerosis funded by Novartis, Biogen, and GSK. Investigator grant from Novartis outside this work. Advisory Boards for Roche and Merck.
Abstract: 218
Type: Oral
A major issue in trying to alter the gradient of progression in multiple sclerosis (MS) is the time and expense of phase 2 programmes, both investigator and pharma-led. There is no shortage of promising molecules and/or pathways to be explored, but each trial is likely to take at least 5 years from set-up to final result. Moreover, without a well conducted phase 2 trial, the chance at success at phase 3 is correspondingly reduced. Quicker, more efficient and different trial design structures must be found and implemented to reduce the timeline, both for drug development and non-drug intervention (eg physiotherapy).
Here I will explore some of those methods including: multi-arm, adaptive, n of 1, Simon-2-stage, and Bayesian concepts. Examples will be given, looking at previous experience, as well as what could and should be done in the future.
Disclosure: Efficacy and Mechanism Evaluation Programme (NIHR), UK Multiple Sclerosis Society, University College London Hospitals/UCL Biomedical Research Centres funding scheme. Local principal investigator for trials in multiple sclerosis funded by Novartis, Biogen, and GSK. Investigator grant from Novartis outside this work. Advisory Boards for Roche and Merck.