In 2010 the ISCTM instituted Working Groups to address specific issues, with goal of developing a 'product'.  If you are an ISCTM member interested in joining a current Working Group, please contact the Secretariat. If you are an ISCTM member interested in forming a Working Group, please review Criteria for Working Groups and submit proposal to the ISCTM Scientific Chair.

Working Groups - Current

Adaptive Design Clinical Trials 
Chair:  Virginia Sutton Haynes, PhD,  Eli Lilly and Company
Next call dates:
Thursday 1 December 2011, 11:00 Eastern
Thursday 15 December 2011, 11:00 Eastern
Next face to face: 21 February 2012 Working Group Dinner
Adaptive Design in CNS Trials
Email the Secretariat to receive a Meeting Announcement
Most Recent Activity: Workshop at 2011 Autumn Conference 
Continuing Work:  Simulation work for a Phase II trial for a mock compound in schizophrenia; Manuscript on Introduction to Adaptive Design in Psychiatry
Previous Activity. Group was originally formed to provide a response to the FDA on their Guidance for Industry, "Adaptive Design Clinical Trials for Drugs and Biologics".  Feedback was submitted to the FDA June 2010.  ISCTM Response to FDA Guidance for Industry: Adaptive Design Clinical Trials. 

Biomarkers Working Group
Chairs: Steven Potkin, MD; Henry Riordan, PhD
Objectives: CNS drug developers currently lack many of the tools necessary to implement the use of biomarkers in the later stages of the drug development process. Given this, and the burden of development and qualification of biomarkers in terms of both time and cost, the formation of collaborative international groups to undertake these biomarker related challenges is essential.  These challenges provide a unique opportunity for meaningful industry-academia-government collaboration. The Biomarkers Working Group (BWG) is being formed to help meet these challenges while ensuring that the interests and expertise of the International Society for CNS Clinical Trials and Methodology are meaningfully consolidated and communicated.
Next face to face: 21 February 2012 Working Group Dinner
Biomarkers
Registration opens Mid-November 2011
Email the Secretariat to receive a Meeting Announcement
Most recent activity: Evaluating Biomarkers for Schizophrenia: Issues in Identification, Categorization and Evaluation Workshop at 2011 Autumn Conference
Next Working Group Call date: TBD

Mitochondrial Systems
Chair: Charles Bowden, MD, University of Texas Health Science Center at San Antonio
Next call date: TBD
Objectives: Develop workshop for February 2012 8th Annual Scientific Meeting, Washington D.C.; Develop white paper
Next face-to-face Meeting Date: 21 February 2012 Working Group Dinner
Mitochondrial Systems
Registration opens Mid-November 2011
Email the Secretariat to receive a Meeting Announcement
Most recent activity: Summary of working group conducted at February 2011 7th Annual Scientific Meeting, Washington D.C.          

Suicidal Thinking and Behavior Assessment in Clinical Trials: Methodological and Technical Challenges 
Co-Chairs:  Adam Butler, United BioSource Corporation
                   Michelle Stewart, MD, Pfizer, Inc.
Objectives: Further data-analysis of SBT Site survey results for presentation in February. In parallel to the survey effort, group will use the same challenges document being drafted for the survey effort to start an outline for a “Thought Piece”.
Next call dates:
Friday 18 November, 10:00 am Eastern
Friday 16 December, 10:00 am Eastern
Next face to face meeting: 21 February 2012 Working Group Dinner
Suicidal Thinking and Behavior
Registration opens Mid-November 2011
Email the Secretariat to receive a Meeting Announcement
Most recent activity: Suicidal Thinking and Behavior Assessment: Implementation in Current Trials Workshop 2011 Autumn Conference
Poster presented at ISCTM Autumn Conference
Previous Activity:Summary of working group conducted  at February 2011 7th Annual Scientific Meeting, Washington, D.C.

Negative Symptoms
Reconvening with 21 February 2012 Working Group Dinner
Negative Symptoms Trial Methodology

Signal Detection
Reconvening with 21 February 2012 Working Group Dinner
Approaches to Improve Signal Detection

Working Groups - Completed

Comment on AHRQ Draft Workgroup Report: Antipsychotics in Adults: Comparative Effectiveness of First-Generation versus Second-Generation Medications
Chair: Larry Alphs, MD, PhD
ISCTM Comment document: Submitted 12 July 2011
(Link to original document has been deactivated by AHRQ)

Comment on Concept to Revise EMA Guidance on Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia (Completed)
Chair: Douglas Feltner, MD
Objective of group was to review and draft response to Concept paper on the revision of the EMA Guidance as listed above, then review and respond to actual Guidance document when it is released.   ISCTM Response to EMA Concept Paper on Revision of the EMA Guidance

Non-Inferiority Clinical Trials (Completed)
Chair:  Andrew C. Leon, PhD, Weill Cornell Medical College
Group was formed to provide feedback to the FDA on their draft Guidance for Industry, "Non-Inferiority Clinical Trials".  Feedback was submitted to FDA May 2010.
ISCTM Response to FDA Guidance for Industry: Non-inferiority Clinical Trials  

Qualification Process for Drug Development Tools (Completed)
Co-Chairs: Douglas Feltner, MD, Douglas Feltner Biopharma Consulting
                     Michael Davidson, MD, Sheba Medical Center
Call Dates: Wednesday 15 December 12:00-1:00 PM Eastern
                     Friday 7 January, 11:00 am - 12:00 pm Eastern
                     Wednesday 12 January, 12:00-1:00 PM Eastern
 ISCTM Comment on FDA Draft Guidance  on "Qualification Process for Drug Development Tools" (DDTs), which include patient-reported outcomes, biomarkers, and other tools.  This draft guidance outlines a process for how tool developers can interact with FDA to obtain FDA acceptance of their tool.  
ISCTM Comment - Submitted 24 January 2011