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Synergy in Action

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. We are pleased to announce that two of the sessions accepted for presentation at the 11th Annual Scientific Meeting (17-19 Feb 2015) come from proposals from ISCTM Working Groups.

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.

SIB Consensus Meeting subcommittee  WORKING GROUP PAGE

Comments on Guidelines and Initiatives – Found below Working Group Activity

ADAPTIVE DESIGN
Chairs: Ron Marcus, MD; Judith Kando, PharmD
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.
Next Activities
14 September 2016 Webinar CASE STUDIES IN ADAPTIVE DESIGN: Re-estimation of sample size and sequential parallel comparison design (To receive a registration email, please email the Secretariat)
Session on Adaptive Design will be presented at the 13th Annual Scientific Meeting, 21-23 February 2017, Washington DC
Activity History:
Webinars:
View: Are Adaptive Trials an Appropriate Design Choice in Neuroscience

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)
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.

ADDRESSING METHODOLOGICAL CHALLENGES IN INTERNATIONAL CNS CLINICAL TRIALS
Chairs: Amir Kalali, MD; Elizabeth Pappadopulos, PhD
Finalizing Survey updates formulated during Autumn 2014 Conference.
Next Activity:  2016 Autumn International Conference Workshop, 26 September 2016, Philadelphia, PA
Activity History:
Working Group Dinner, 17 February 2015
Presentations Slides, Working Group Report Back Summary
2014 Autumn Conference – 6 October 2014, Boston, MA 
Working Group Dinner, 18 February 2014
2013 Autumn Conference, Inaugural Workshop, 30 September 2013, Philadelphia, PA

ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs
Chairs: Jonathan Rabinowitz, PhD; Nina R. Schooler, PhD
Next Activity: 2016 Autumn Algorithms/Flags Conference Workshop, 26 September 2016, Philadelphia PA
Activity History
Working Group Poster presented at SIRS 2016
Working Group Dinner  – 17 February 2015, 11th Annual Meeting (Washington DC)
2014 Autumn Conference – Inaugural Workshop, 6 October 2014, Boston, MA

ASSESSING ABUSE LIABILITY POTENTIAL
Chairs: Marta Sokolowska, PhD; Michael Klein, PhD; Beatrice Setnik, PhD
Activity History:
11th Annual Scientific Meeting Session Presentations  Regulatory Guidelines and Methodological Approaches to Assess Prescription Drug Abuse and Misuse During CNS Drug Development
Working Group Dinner Report Back Summary, 17 February 2015, Washington DC
Working Group Dinner
, 19 February 2013, Washington DC,
Working Group Dinner, 21 February 2012, Washington DC

BPSD
Chairs: Larry Ereshefsky, PharmD; David Miller, MD; Luca Pani, MD
Objectives: This working group is being convened to focus on the methodological challenges facing the development of treatments for the Behavioral and Psychiatric Symptoms of Dementia (BPSD). This group is in part stimulated by the recent EMA Alzheimer’s Disease Workshop which highlighted the methodological challenges and serves as a robust starting point to define our Working Group’s scope.  Some of the issues we may discuss are: Understanding how evolving AD diagnostic and biomarker approaches affect development of Rx for BPSD (pre dementia, early, late categorizations with various diagnosis and staging structures  (DSM V, NIA-AA, IWG)); Proposing innovative trials designs and regulatory acceptance; Managing intrinsic variability of symptoms; Rx of existing symptoms or delays/prevention of likely to occur symptoms of BPSD; Regulatory perspectives and Review of lessons learned from ongoing and prior clinical trials for BPSD. 
If you wish to join this group, email the Secretariat.
Current Activity: BPSD Workshop, 2016 Autumn Conference.  This will be a closed session to integrate the information from the February meeting and finalize next steps for upcoming activities. 
Workshop Objective:In depth substantive planning to implement the group’s strategic vision and road map for a series of ISCTM activities, ultimately, leading to the establishment of a consensus group meeting to further the development of treatments of Apathy and Agitation/Psychosis in Dementia.
Workshop Deliverables:Active collaboration with other professional groups, i.e., ISTAART PIA; Draft final program for 2017 Autumn meeting in Paris (31 Aug-2 Sept 2017); Program Agenda, Objectives, and suggested speakers/panel discussants; Identification of additional ISCTM supported activities to move towards a consensus group on drug development of BPSD
Activity History
Inaugural Meeting, Working Group Dinner Report Back Summary, 17 February 2015, The Fairmont Washington DC

BIOMARKERS
Chairs: Steven Potkin, MD, Don Goff, MD
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.
Next Activity: 2016 Autumn Biomarkers Conference Workshop, 26 September 2016, Philadelphia, PA
Publications:
Biomarkers for drug development in early psychosis: Current issues and promising directions
Goff DC, Romero K, Paul J, Perez-Rodriguez M, Crandall D, Potkin SG
European Neuropsychopharmacology 2016.01.009 (Public Access permission obtained)
Activity History:
Working Group Dinner Report Back Summary, 17 February 2015
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
Autumn 2012 Autumn Conference Workshop
21 February 2012 Biomarkers Working Group Session Plenary Report Back
Autumn 2012 Autumn Conference Workshop
21 February 2012 Biomarkers Working Group Session Plenary Report Back
2011 Autumn Conference Evaluating Biomarkers for Schizophrenia: Issues in Identification, Categorization and Evaluation Workshop

COGNITIVE ASSESSMENT IN ALZHEIMER’S DISEASE
Chairs: Holly Posner, MD; Philip Harvey, PhD
Next Activity: 2017 Autumn Cognitive Assessment Conference Workshop
Activity History:
Finalizing two manuscripts
Working Group Dinner, 17 February 2015, Washington DC
Presentations:  Cosentino; Schneider; Report Back Summary
2014 Autumn Conference, 6 October 2014, Boston, MA
Working Group Dinner
, 18 February 2014, Washington DC
2013 Autumn Conference – 30 September 2013, Philadelphia, PA
(Session presentation slides found in Autumn Meeting file in LIBRARY)
Working Group Dinner
, 18 February 2013, The Fairmont Washington DC
2012 Autumn Conference Workshop

IDENTIFYING NONADHERENCE IN CNS CLINICAL TRIALS
Thomas Shiovitz, MD; David McCann, PhD
Current Activity: 2016 Autumn Conference Nonadherence Workshop
Activity History:
Working Group Dinner Report Back Summary, 17 February 2015, Washington DC
Autumn 2014 – Working group is currently meeting to develop white paper.
2014 Autumn Conference, Inaugural Workshop, 6 October 2014
Nonadherence: A bitter pill for drug trials (Science 17 Oct 2014, Vol 346 #6207)

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, PA

NEGATIVE SYMPTOMS
Chairs: Stephen Marder, MD; David Daniel, MD
Activity History:
2014 Autumn Conference – 6 October 2014, Boston, MA
2013 Autumn Conference – 30 September 2013, Philadelphia, PA
(Session presentations slides found in Autumn Meeting file in LIBRARY)
2012 Autumn Negative Symptoms Working Group Session Plenary Report Back
Negative Symptoms Working Group Session Summary
Members who attended Working Group Dinner at 8th Annual Meeting received invitation to attend meeting of the group at the SIRS conference, April 2012, Florence Italy.

SUICIDAL IDEATION AND BEHAVIOR ASSESSMENT
Chairs: Larry Alphs, MD, PhD; Phillip Chappell, MD, MBA; Michelle Stewart, PhD
Current Activity:  Developing multiple publications from the 2015 Consensus meeting.
Activity History:
Consensus Meeting on Methodological Considerations for Suicide Assessment and Clinical Trial Design 17-18 November 2015
Publications:
Innovations in Clinical Neuroscience: October 2014 Prospective Assessment of Suicidal Ideation and Behavior: An Internet Survey of Pharmaceutical Sponsor Practices
Innovations in Clinical Neuroscience: May-June 2013 (ISCTM Supplement #1) (Study Site Experiences)
10th Annual Meeting Poster Presentation:Prospective Suicidal Ideation and Behavior Assessment:  An Internet Survey of Pharmaceutical Sponsor Practices
Working Group Dinner, 17 February 2014, Washington DC
Presentation; Report Back Summary
2013 Autumn Conference – 30 September 2013, Philadelphia, PA
Working Group Dinner, 19 February 2013, The Fairmont, Washington, DC
Plenary Session at 2013 Annual Scientific Meeting – Suicidal Ideation and Behavior: Methodological and Technical Challenges
Manuscript completed – pending publication in Innovations in Clinical Neuroscience
ISCTM Comment on (2012) FDA Draft Guidance for Industry “Suicidality: Prospective Assessment of Occurrence in Clinical Trials
21 February 2012 SIB Working Group Session Plenary Report Back
Poster presented at NCDEU 2012

Poster presented at ISCTM 2011 Autumn Conference
Summary of working group conducted at February 2011 7th Annual Scientific Meeting, Washington, D.C.
ISCTM Comment on (2010)FDA Draft Guidance for Industry “Suicidality: Prospective Assessment of Occurrence in Clinical Trials

ISCTM Comments on Guidelines and Initiatives:

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

Completed (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