Adaptive Design Working Group Activity / Deliverables
Chairs: Ron Marcus, MD; Judith Kando, PharmD, BCPP
Group conducts monthly telecons. Email the Secretariat if you are interested in joining the group. You must be a member to participate in an ISCTM working group.
Most recent activity:
Webinar: View- Platform Trials – An Adaptive Design: Construct, Advantages and Challenges
Publications:
Adaptive Design – Overview of Early Phase Designs and Challenges, Therapeutic Innovation and Regulatory Science (January 2014)
O Marchenko, V Fedorov, J Lee, C Nolan, J Pinheiro
Adaptive Design Applied to Identification of the Minimum Effective Dose in Schizophrenia: Simulations of Scientific and Commercial Value Therapeutic Innovation and Regulatory Science (October 2013)
WEBINAR SERIES: (These webinars are available for viewing fee waived by all ISCTM members.)
View: Platform Trials – An Adaptive Design: Construct, Advantages and Challenges
View: Case Studies in Adaptive Design: Re-estimation of sample size and sequential parallel comparison design
View: Are Adaptive Trials an Appropriate Design Choice in Neuroscience
Activity History:
Working Group Session – 14th Annual Scientific Meeting:View WG Presentations
13th Annual Scientific Meeting session: Advantages and Challenges of Adaptive CNS Trials: Real World Lessons
11th Annual Meeting Session Presentations: Adaptive Design in the Real World: Implications for Neuroscience Clinical Trials
11th Annual Meeting Poster Presentation: Novel Adaptive Design in Schizophrenia: Case Study in Constructing a Point-of-Care Clinical Trial Design with Adaptive Population Enrichment
2014 Autumn Workshop, 6 October 2014, Boston, MA
Working Group Dinner, 18 February 2014, Washington DC
2013 Autumn Workshop, 30 September 2013, Philadelphia, PA
Working Group Dinner, 19 February 2013, Washington DC
2012 Autumn Conference Workshop
21 February 2012 Working Group Session Plenary Report Back
8th Annual Scientific Meeting Poster Presentation – Simulation work for a Phase II trial for a mock compound in schizophrenia.
2012 Autumn Conference Workshop
21 February 2012 Working Group Session Plenary Report Back
8th Annual Scientific Meeting Poster Presentation – Adaptive versus traditional design approaches to target dose estimation
Workshop at 2011 Autumn Conference
Response to the FDA on their Guidance for Industry, “Adaptive Design Clinical Trials for Drugs and Biologics”. ISCTM Response to FDA Guidance for Industry: Adaptive Design Clinical Trials.