Mary Bea Harding « ISCTM | The International Society for CNS Clinical Trials and Methodology

Working Group Goal:
Review status and develop consensus statements regarding policies and educational initiatives that support optimal public health approaches to SIB.

Possible Activities:
–Review key issues and challenges regarding translation of research on methodology of SIB assessment into clinical practice.

–Review key issues and challenges of translation of research on SIB assessment and treatment into effective public policy

Identification of the stakeholders (private and public sectors, world health)
Review considerations for driving better public health practice in the area of SIB detection, prevention, treatment and make recommendations
Review challenges in collection of population based data and make recommendations
Review implications of lack of consistent nomenclature/classification

–Consider how to address the perspective of the patient who lives with SIB and make recommendations

Sub-group Members:
Larry Adler, University of Maryland
Larry Alphs, Janssen
Reyn Archer, Burson-Marstellar
Sharon Fernando, INC Research
John Greden, University of Michigan
Joe Hulihan, Paradigm Consulting, LLC
Edward Kim, Janssen
Chris Kosseff, Rutgers University
Mark Lerman, Alexian Brothers Medical Center
John Madigan, AFSP
Heddie Martynowicz, Janssen
Maju Mathews, Janssen
Sian Ratcliffe, Pfizer
Jair Soares, UT Houston Medical School
Nicolas Werner, Richmond Fellowship
Sid Zisook, University of California, San Diego

Developing Policy and Education Initiatives Working Group Internal Documents

Design and Methodology for SIB Treatment Studies Sub-group

Monday, June 1st, 2015

Design and Methodology for SIB Treatment Studies Bibliography

Working Group Goal:
Review current approaches and develop consensus on the key requirements for design of clinical studies and programs to be used for regulatory approval of therapies to treat SIB

Possible Activities:

–Compare design approaches: Independent, trans-nosological identification (ie, across primary psychiatric or medical diagnoses) vs. linked to diagnosis (e.g. as a symptom of depression or anxiety)

–Review study design considerations for treatment trials and make recommendations

–Review acute and maintenance designs and make recommendations

–Review patient selection and make recommendations

–Review considerations around use of placebo and make recommendations

–Review outcome measures and make recommendations

–Review use of biomarkers

Review of promising biomarkers for SIB
Develop considerations and recommendation regarding inclusion in SIB treatment trials

–Review management of suicide risk in clinical trials and make recommendations

Sub-group Members:

Alan Brier, Indiana University
Heather Bryson, PPDI
Bob Buchanan, University of Maryland
Carla Canuso, Janssen
Jordan DeVylder, University of Maryland
Franco Di Cesare, Leoben Research
Ebrahim Haroon, Emory University
Yuko Hirata, INC Research
Sid Kennedy, University of Toronto
Andrew Krystal, Duke University
William Lenderking, Evidera
J.P. Lindenmayer, Nathan Kline Institute
Herbert Meltzer, Northwestern University
Andrew Nierenberg, Massachusetts General Hospital
Charles Nemeroff, University of Miami
Tina Oakes, Lilly
Anne-Marie Quinn, Janssen
David Sheehan, University of South Florida
Michelle Stewart, Pfizer
Eliseo Salinas, Turing Pharmaceuticals
David Walling, Collaborative Neuroscience Network

Design and Methodology for SIB Treatment Studies Internal Working Group Documents

Analysis of SIB Data Subgroup

Monday, June 1st, 2015

Analysis of SIB Data Bibliography

Working Group Goal:
Review current status and develop consensus regarding guiding principles and considerations when analyzing existing SIB data at the study, program and meta-analytic level and identification of gaps in current analytic approaches

Possible Activities:

–Review approaches for summarizing and analyzing clinical trial and project level data

Summarization of SIB data without respect to treatment
Analysis of SIB data in association with treatment
Aggregation of SIB data with other study endpoints (eg, MADRS)
Use of common data elements
Relationship between SIB assessments and AE reporting
Meta-analysis/network analysis of existing large datasets

–Review approaches for leveraging big data for SIB datasets and identifying emerging opportunities

–Identify challenges in assembling and analyzing large SIB datasets

Sub-group Members:

Munaf Ali, Munaf Ali Consultancy
John Davies, GSK
Bryan Dirks, Shire
Sarah DuBrava, Pfizer
Rebecca Evans, Parexel
Michael Federico, ERT
Andrew Freeman, Univ of Nevada, Las Vegas
Mark Gordon, Boehringer-Ingelheim
Pilar Lim, Janssen
Cristiana Mayer, Janssen
Mary Nilsson, Lilly
Jill Rasmussen, psi-napse
Madhukar Trivedi, Univ of Texas SWMC
Christine Ulbricht, UMass Medical School
Robieson Weining, AbbVie
Anna van Meter, Einstein College of Medicine
Benedetto Vitiello, NIMH
Jun Zhao, AbbVie

Analysis of SIB Data Working Group Internal Documents

Instrumentation & Special Populations SIB Sub-group

Monday, June 1st, 2015

Instrumentation and Special Populations Bibliography

Working Group Goal:

Review status and develop consensus on key considerations regarding the detection and assessment of SIB across different patient populations

Possible Activities:

–Key considerations of instruments for assessing presence and severity of SIB

Psychometric properties and validation considerations

–Suitability of a single measure to assess SIB in all studies and all populations

Issue of special populations

– Pediatric patients

– Cognitively impaired patients

–Look back periods

Establishing best approaches to improve lifetime recall

–Frequency and duration of data collection in clinical trials

–Training requirements for clinician-administered assessments

–Integration of information from various sources

Clinician/rater administered assessments
Patient reported assessments
Use of third party informants

–Pros & cons of using technology to assess SIB

–Cross-cultural considerations

Sub-group members:

Mark Bangs, Lilly
Florence Butlen, EMA
Martin Cheatle, Univ of Pennsylvania
Wen-Hung Chen, FDA
John Greist, Healthcare Technology Systems
Jill Harkavy-Friedman, American Foundation for Suicide Prevention
Diane Hollman, Clinilabs
Lynne Johnson, Lilly
J. John Mann, Columbia University
Derrick McKinley, Pfizer
Joe Palumbo, Mitsubishi Tanabe
Donna Palumbo, Pfizer
Michael Ryan, Novartis
Barbara Stanley, Columbia University
Steve Targum, Clintara
Oleg Tcheremessine, Carolina Healthcare System
Lynn Webster, PRA Health Sciences
Janet Williams, MedAvante
Christian Yavorsky, CROnos

Instrumentation and Special Populations Working Group Internal Documents