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. If you are an ISCTM member interested in joining a current Working Group, please fill out this form: Working Group Interest Form. 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.

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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.  Completed or ‘Dormant’ working group information found below Guideline Comments

ACCELERATING DEVELOPMENT OF PSYCHOPATHOLOGY MEASURES – ISCTM/ECNP Joint Working Group
Chairs: Nina R. Schooler, PhD; Celso Arango, MD, PhD; Jenicka Engler, PsyD

ADVANCING THE METHODS TO EVALUATE ABUSE AND DEPENDENCE-POTENTIAL IN CLINICAL STUDIES FOR CNS-ACTIVE DRUGS AND NOVEL PSYCHEDELICS
Chairs: Beatrice Setnik, PhD; Jadwiga Martynowicz, PhD

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

ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING FOR CNS CLINICAL TRIALS
Chairs: Larry Alphs, MD, PhD; Adam Butler
Placebo Sub-group: Deliverable complete; see Working Group page for details 
Digital Biomarkers Decision Process Sub-group: Chairs – Vikas Mohan Sharma, MD; Anzar Abbas, PhD

ASSESSMENT OF METHODS AND ENDPOINTS FOR RAPID-ACTING ANTIDEPRESSANTS-RAADs 
Chairs: Christian Yavorsky, PhD; Jan Sedway, PhD 

BEHAVIORAL AND PSYCHIATRIC SYMPTOMS IN DEMENTIA (BPSD)
Steering Committee Chair: Larry Ereshefsky, PharmD
Apathy Sub-group: Chairs – Krista Lanctot, PhD; David Miller, MD, MA
Agitation Sub-group: Group sunsetted; see Working Group page for details

DEVELOPING INTEGRATED INTERVENTIONS: CLINICAL TRIALS FOR DRUG/NEUROMODULATION – PSYCHOTHERAPY COMBINATIONS
Chairs: Walter Dunn, MD, PhD; Zimri Yaseen, MD

DEVELOPING STRATEGIES TO IMPROVE RECRUITMENT FOR CLINICAL TRIALS TARGETING NEUROPSYCHIATRIC SYMPTOMS (NPS) IN MEMORY DISORDERS
Chairs: Moyra Mortby, PhD; Paul Rosenberg, MD

DEVELOPMENT OF NOVEL ENDPOINTS FOR CLINICAL TRIALS IN SUBSTANCE USE DISORDERS
Chairs: Tanya Ramey, MD, PhD; Martin Mumenthaler, PhD

DIVERSITY IN CNS CLINICAL TRIALS
Chairs: Abhishek Pratap, PhD; Siân Ratcliffe, PhD

ESTIMANDS AND MISSING DATA
Chairs: Elena Polverejan, PhD; Lorenzo Guizzaro, MD, PhD

METHODOLOGICAL ISSUES IN STUDY DESIGNS FOR CLINICAL TRIALS WITH PSYCHEDELICS
Chairs: Amir Inamdar, MBBS, DNB (Psych), MFPM; Joyce Tsai, PhD

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

ORPHAN DISEASES
Chairs: Joan Busner, PhD; Gahan Pandina, PhD

SLEEP METHODOLOGY IN CNS TRIALS
Chairs: Margaret Moline, PhD; Georg Dorffner, PhD

WORKING GROUP TO REVIEW METHODOLOGY/COLLABORATION FOCUSED GRANT OPPORTUNITIES
Chairs: Atul Mahableshwarkar, MD; Gary Sachs, MD

ISCTM Comments on Guidelines and Initiatives:

Comment on IFCN GREENBEAN Checklist for Reporting Studies Evaluating the Effectiveness of EEG-Based Biomarkers (November 2024)
Chairs: Kemi Olugemo, MD, FAAN; Atul Mahableshwarkar, MD

Comment on FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry (September 2024)
Chairs: Siân Ratcliffe, PhD; Abhishek Pratap, PhD

Comment on FDA Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry (June 2024)
Chairs: Judith Jaeger, PhD; Debra Hoffmeyer, MA

Comment on EMA Guideline on Clinical Investigation of Medicinal Products in the Treatment of Depression (March 2024)
Chairs: Dong-Jing (DJ) Fu, MD, PhD; Amir Inamdar, MBBS, DNB (Psych), MFPM 

Comment on EMA Reflection Paper on Establishing Efficacy based on Single-Arm Trials Submitted as Pivotal Evidence in a Marketing Authorisation (September 2023)
Chairs: Atul Mahableshwarkar, MD; Siân Ratcliffe, PhD 

Comment on FDA Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (August 2023)
Chairs: Amir Inamdar, MBBS, DNB (Psych), MFPM; Joyce Tsai, PhD

Comment on FDA Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products Guidance for Industry (May 2023)
Chairs: Debra Hoffmeyer, MA; Siân Ratcliffe, PhD

Comment on FDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations-Draft Guidance for Industry, Investigators, and Other Stakeholders (March 2022)
Chairs: Debra Hoffmeyer, MA; Richard Keefe, PhD; Michael Sand, PhD, MPH

Comment on FDA Enhancing Diversity of Clinical Trial Populations-Eligibility Criteria-Enrollment Practices-Trial-Designs Guidance for Industry (August 2019)
Chairs: Debra Hoffmeyer, MA, CCRC; Atul Mahableshwarkar, MD

Comment on FDA Attention Deficit Hyperactivity Disorder-Developing Stimulant Drugs for Treatment-Guidance for Industry (July 2019)
Chairs: Manisha Madhoo, MD; James Rawls, PharmD

Comment on FDA Proposed Regulatory Framework for Modifications to Artificial Intelligence-Machine-Learning Based Software as a Medical Device (SaMD) (June 2019)
Chairs: Adam Butler; Larry Alphs, MD, PhD

Comment on FDA Major Depressive Disorder: Developing Drugs for Treatment Guidance for Industry (August 2018)
Chairs: Carla Canuso, MD; Amir Kalali, MD; Jonathan Rabinowitz, PhD

Comment on FDA Early Alzheimer’s Disease Developing Drugs for Treatment Guidance for Industry (May 2018)
Chairs: Stephen Brannan, MD; Adam Butler; Steven Potkin, MD

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 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 Comment – Submitted 24 January 2011

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

Completed deliverable or ‘dormant’ groups

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

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

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

AUTISM SPECTRUM DISORDER  – ISCTM/ECNP Joint Working Group
Chairs: Valentina Mantua, MD, PhD; Celso Arango, MD, PhD; Tiffany Farchione, MD

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

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

COGNITIVE TRAJECTORIES IN SCHIZOPHRENIA
Chair: Philip Harvey, PhD

COVID-19 CNS CLINICAL TRIAL METHODOLOGIES BLUEPRINT – ISCTM/ECNP Joint Working Group
Chairs: Kemi Olugemo, MD; Dragana Bugarski-Kirola, MD; Gerard Dawson, BSc, DPhil

IDENTIFYING NONADHERENCE IN CNS CLINICAL TRIALS
Phase 2: Chairs: Atul Mahableshwarkar, MD; Ibo Turkoz, PhD
Phase 1: Chairs: Thomas Shiovitz, MD; David McCann, PhD

IMPLEMENTING INNOVATIONS IN CNS CLINICAL TRIALS
Chairs: Gary Sachs, MD; Michael Detke, MD, PhD

INNOVATIVE TECHNOLOGIES FOR CNS CLINICAL TRIALS
Chairs: Richard Keefe, PhD; Michael Davis, MD, PhD

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

LATE-ONSET DEPRESSION: A DISTINCT INDICATION?
Chairs: Peter de Boer, PhD; Patricia Capaccione, RPh

PREVENTION TRIALS IN ALZHEIMER’S DISEASE (Formerly Cognitive Assessment in Alzheimer’s Disease)
Chairs: Holly Posner, MD; Philip Harvey, PhD

STIMULANT DEPENDENCE
Co-Chairs: Joseph Palumbo, MD; Thomas Kosten, MD

MITOCHONDRIAL SYSTEMS
Chair: Charles Bowden, MD

SIGNAL DETECTION
Chair: Amir Kalali, MD