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Working Groups

ISCTM supported Working Groups, initiated in 2010 to address specific issues in greater detail, continue to thrive, providing an outlet for more members to participate in the ongoing work of the Society. One of the visions of the Executive for these working groups was that sessions would arise out of the work done in this setting. Latest meeting of the ISCTM included initial meetings of three new working groups:  Orphan Disease WG (leadership session), Cognitive Dysfunction, and Missing Data.

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 Executive Director.

For detailed information on activities and deliverables for an individual working group, click on the working group title.
Comments
on Guidelines and Initiatives – Found below Working Group List

ADAPTIVE DESIGN
Chairs: Ron Marcus, MD; Judith Kando, PharmD

ADDRESSING METHODOLOGICAL CHALLENGES IN INTERNATIONAL CNS CLINICAL TRIALS
Chairs: Amir Kalali, MD; Elizabeth Pappadopulos, PhD

ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs
Chairs: Jonathan Rabinowitz, PhD; Nina R. Schooler, PhD

ASSESSING ABUSE LIABILITY POTENTIAL
Chairs: Marta Sokolowska, PhD; Michael Klein, PhD; Beatrice Setnik, PhD

BEHAVIORAL AND PSYCHIATRIC SYMPTOMS IN DEMENTIA (BPSD)
Chairs: Larry Ereshefsky, PharmD; David Miller, MD; Luca Pani, MD

BIOMARKERS
Chairs: Steven Potkin, MD, Don Goff, MD

COGNITIVE ASSESSMENT IN ALZHEIMER’S DISEASE
Chairs: Holly Posner, MD; Philip Harvey, PhD

COGNITIVE DYSFUNCTION
Chairs: Jonathon Parker, Phd; Maurizio Fava, MD

ESTIMANDS AND MISSING DATA
Chair: Pilar Lim, MD

IDENTIFYING NONADHERENCE IN CNS CLINICAL TRIALS
Thomas Shiovitz, MD; David McCann, PhD

NEGATIVE SYMPTOMS
Chairs: Stephen Marder, MD; David Daniel, MD

ORPHAN DISEASES
Chairs: Joan Busner, PhD; Judy Dunn, PhD; Ravi Anand, MD

SUICIDAL IDEATION AND BEHAVIOR ASSESSMENT
Chairs: Larry Alphs, MD, PhD; Phillip Chappell, MD, MBA; Michelle Stewart, PhD

ISCTM Comments on Guidelines and Initiatives:

Comment on the EMA Guideline on Multiplicity Issues in Clinical Trials (June 2017)
Chair: Atul Mahableshwarkar, MD
Co-chair: Ibrahim Turkoz, PhD

Comment on HL7 V3 Domain Analysis Model for Generalized Anxiety Disorder (September 2016)
Chair: Nicholas DeMartinis, MD

Comment on FDA Clinical Outcome Assessment Compendium (March 2016)
Chair: Adam Butler
 
Comment on HL7 V3 Domain Analysis Model for Bipolar Disorder (January 2016)
Chair: Gary Sachs, MD

Comment on HL7 V3 Domain Analysis Model for Schizophrenia (November 2013)
Chair: Andrei Pikalov, MD

Comment on HL7 V3 Domain Analysis Model for Major Depressive Disorder
MDD Outcome Measures Ballot (November 2013)
Chair: Andrei Pikalov, MD

World Medical Association Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects (April 2013)
Chair: Steven Potkin, MD
ISCTM Comment document: Submitted 13 June 2013
Final Guidance with ISCTM Recommendations

FDA Guidance on Availability of Masked and De-Identified Non Summary, Safety and Efficacy Data (June 2013)
Chair: Joanne Severe, MS
ISCTM Comment document: Submitted 5 August 2013

FDA Guidance on Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (February 2013)
Chair: Steven Romano, MD
ISCTM Comment document: Submitted 5 April 2013

Comment on FDA Schizophrenia Data Standards Draft (August 2012)
Andrei Pikalov, MD
Group will reconvene for next stage of review, January 2013

EMA Guideline on Clinical Investigation of Medicinal Products in the Treatment of Depression
Chair: Andrei Pikalov, MD, PhD
ISCTM Comment document:Submitted 29 March 2012

NAPA’s Scientific Agenda for a National Initiative on Alzheimer’s Disease
Chair: Larry Ereshefsky, PharmD, BCPP
ISCTM Comment document: Submitted 14 March 2012

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)

Concept to Revise EMA Guidance on Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia
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
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” (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.
Co-Chairs: Douglas Feltner, MD, Douglas Feltner Biopharma Consulting, Michael Davidson, MD, Sheba Medical Center
ISCTM CommentSubmitted 24 January 2011

ISCTM Comment on (2010)FDA Draft Guidance for Industry “Suicidality: Prospective Assessment of Occurrence in Clinical Trials

Completed or ‘dormant’ groups

IMPLEMENTING INNOVATIONS IN CNS CLINICAL TRIALS
Chairs: Gary Sachs, MD; Michael Detke, MD, PhD
Telecons scheduled for 2014 as group continues work started in Autumn 2013 and February 2014.
Workgroup Resources 
Activity History:
Developing Manuscript
Working Group Dinner, 17 February 2015, 11th Annual Meeting (Washington DC)
Presentation slides
2014 Autumn Conference, 6 October 2014, Boston, MA
Working Group Dinner, 18 February 2014, Washington DC
2013 Autumn Conference Inaugural Workshop, 30 September 2013, Philadelphia, PACompleted (or currently ‘dormant’) Working Groups

Stimulant Dependence
Co-Chairs: Joseph Palumbo, MD
Thomas Kosten, MD
Objectives: Group will review the cocaine addiction field and the evolution of pharmacotherapies from the animal models, current pharmacotherapies and their relative efficacy, and the industry hurdles to moving those pharmacotherapies to commercialization, with objective of producing a peer reviewed publication.
Next F2F: TBD
Activity History:
Working Group Dinner, 19 February 2013, The Fairmont, Washington, DC
Initial Workshop:
2012 Autumn Conference Stimulant Dependence Workshop
Telecon Schedule: No calls scheduled at this time

Mitochondrial Systems
Chair: Charles Bowden, MD, University of Texas Health Science Center at San Antonio
Objectives: Develop white paper
Activity History:
Summary of working group conducted at February 2011 7th Annual Scientific Meeting, Washington D.C.

Signal Detection
Next F2F: Group is finalizing 2 manuscripts. 
Activity History:
Working Group Dinner, 19 February 2013, The Fairmont, Washington, DC
2012 Autumn Conference Signal Detection Workshop
21 February 2012 Signal Detection Working Group Session Plenary Report Back
Objectives: Finalize two manuscripts