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Opportunities and Challenges in Drug Development for ASD: Product of ISCTM/ECNP Joint Working Group

Celso Arango, Tiffany Farchione, Valentina Mantua , James C. McPartland, Geraldine Dawson, Gahan Pandina, Dragana Bugarski-Kirola, Ronald N Marcus
European Neuropsychopharmacology, Volume 48, July 2021 (Special Issue)

Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions

James T. McCracken , Evdokia Anagnostou, Celso Arango, Geraldine Dawson, Tiffany Farchione, Valentina Mantua, James McPartland, Declan Murphy, Gahan Pandina, Jeremy Veenstra-VanderWeele, the ISCTM/ECNP ASD Working Group
European Neuropsychopharmacology, Volume 48, July 2021 (open access)

Diagnostic criteria for apathy in neurocognitive disorders

Krista L. Lanctôt , David S. Miller, Philippe Robert, Larry Ereshefsky, Lawrence Adler, Daniel Bateman, Jeff Cummings, Steven T. DeKosky, Corinne E. Fischer, Masud Husain, Zahinoor Ismail, Judith Jaeger, Alan J. Lerner, Abby Li, Constantine G. Lyketsos, Valeria Manera, Jacobo Mintzer, Hans J. Moebius, Moyra Mortby, Didier Meulien, Stephane Pollentier, Anton Porsteinsson, Jill Rasmussen, Paul B. Rosenberg, Myuri T. Ruthirakuhan, Mary Sano, Carla Zucchero Sarracini
Alzheimer's & Dementia, May 2021 (open access)

Consistency Checks to Improve Measurement with the Personal and Social Performance Scale (PSP)

Jonathan Rabinowitz, PhD , Mark Opler, MA, Alon A Rabinowitz, Selam Negash PhD, MSc, Ariana Anderson, PhD, Dong Jing Fu, MD, PhD, David Williamson, PhD, Alan Kott, MUDr, Lori L Davis, MD, Nina R Schooler, PhD
Schizophr Res . 2020 Nov 25;S0920-9964(20)30580-6. doi: 10.1016/j.schres.2020.11.040. (open access)

A Framework for Developing Pharmacotherapy for Agitation in Alzheimer’s Disease: Recommendations of the ISCTM Working Group

Cedric O’Gorman, MD , Rita Khoury, MD; Ariana Anderson, PhD; Monique Carter, MS; Franco DiCesare, MD; Sanjay Dubé, MD; Larry Ereshefsky, PharmD; George Grossberg, MD; Nanco Hefting, MSc; Saima Khan, PhD; Stephan Lind, BSc; Hans Moebius, MD,PhD; Thomas Shiovitz, MD; Paul Rosenberg, MD
Journal of Prevention of Alzheimer's Disease (2020) (open access)

Innovative Approaches for Slowing Disease Progression in Parkinson’s Disease: Takeaways from the 14th Annual International Society for Central Nervous System Clinical Trials and Methodology Scientific Meeting

Monica Javidnia, PhD , Mark Frasier, PhD; Ira Shoulson, MD; Ibrahim Turkoz, PhD; and Kumar Budur, MD, MS
Innov Clin Neurosci. 2020;17(14–19) (open access)
The International Society for Central Nervous System Clinical Trials and Methodology (ISCTM) partnered with the Michael J. Fox Foundation for Parkinson’s Research to hold a joint session on innovation in Parkinson’s disease research at the ISCTM 14th Annual Scientific Meeting held February 20 to 22, 2018 in Washington, D.C. The session focused on (1) biomarkers and outcomes measures in Parkinson’s disease clinical trials; 2) clinical trial designs, outcomes, and statistical approaches; and 3) the path forward. This paper aims to summarize key takeaways from the session presenters, panelists, and audience members.

Issues and Perspectives in Designing Clinical Trials for Negative Symptoms in Schizophrenia: Consensus Statements

Stephen R Marder, MD , Michael Davidson, MD, Silvia Zaragoza, PhD, Alan Kott, MUDr, Anzalee Khan, PhD, Xingmei Wang, MS, Dawn I Velligan, PhD, Daniel Umbricht, PhD, Remy Luthringer, PhD, David Daniel, MD
Schizophrenia Bulletin Open, Volume 1, Issue 1, January 2020 (open access)
Individuals from academia, the pharmaceutical industry, and regulators reevaluated earlier recommendations for the design of clinical trials for negative symptoms based on data from recent large trials. A session in February, 2018 at the International Society of CNS Clinical Trails and Methodology (ISCTM) annual meeting reviewed results from selected trials that reported findings between 2013 and 2018. The group reached a consensus on prior recommendations that should be reconsidered in future trials which included: (1) How can placebo effects be minimized? (2) Should global measures of negative symptoms be included? (3) Should a new drug targeting negative symptoms be tested in a monotherapy design or in an add-on design? (4) Can new information from negative symptom trials inform the selection of clinical outcome assessments (COA’s) for future trials? For each of these issues new data was evaluated, discussed by the group, and in some cases the earlier recommendations were revised.

Consistency checks to improve measurement with the Montgomery-Asberg Depression Rating Scale (MADRS)

Jonathan Rabinowitz , Nina R. Schooler, Brianne Brown, Mads Dalsgaard, Nina Engelhardt, Gretchen Friedberger, Bruce J. Kinon, Daniel Lee, Felice Ockun, Atul Mahableshwarkar, Joyce Tsai, Janet B.W. Williams, Colin Sauder, Christian Yavorsky, ISCTM ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs working group members
Journal of Affective Disorders article/S0165032718332105 (open access)
International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Montgomery-Asberg Depression Rating Scale (MADRS). Twenty-two flags were identified. Seven flags are believed to be strong flags that suggest that a thorough review of rating is warranted. The flags were applied to assessments derived from the NEWMEDS data repository. Almost 65% of ratings had at least one inconsistency flag raised and 22% had two or more. Application of flags to clinical ratings may improve reliability of ratings and validity of trials.

Assessment of Suicidal Ideation and Behavior: Report of the International Society for CNS Clinical Trials and Methodology Consensus Meeting

Phillip Chappell, MD, MBA , Michelle Stewart, PhD; Larry Alphs, MD, PhD; Franco DiCesare, MD; Sarah DuBrava, MS; Jill Harkavy-Friedman, PhD; Pilar Lim, PhD; Sian Ratcliffe, PhD; Morton M. Silverman, MD; Steven D. Targum, MD; and Stephen R. Marder, MD
J Clin Psychiatry 2017;78(6):e638–e647 (Open Access)
Objective: To develop consensus recommendations for assessment of suicidal ideation/suicidal behavior (SI/SB) in clinical trials.

Participants: Stakeholders from academia, industry, regulatory agencies, National Institutes of Health, National Institute of Mental Health, and patient advocacy organizations participated in a consensus meeting that was sponsored by the International Society for CNS Clinical Trials and Methodology and held November 17–18, 2015. Prior to the meeting, teams of experts identified key areas of consensus and dissent related to SI/SB. The most critical issues were presented and discussed in the consensus meeting.

Evidence: Literature reviews and a pre-meeting survey were conducted. Findings were discussed in pre-meeting working group sessions and at the consensus meeting.

Consensus Process: Five pre-meeting working groups reviewed (1) nomenclature and classification schemes for SI/SB, (2) detection and assessment of SI/SB, (3) analysis of SI/SB data, (4) design of clinical trials for new treatments of SI/SB, and (5) public health approaches to SI/SB. A modification of the RAND/UCLA Appropriateness Method was used to combine review of scientific evidence with the collective views of experts and stakeholders to reach the final consensus statements. After discussion, all attendees voted using an electronic interactive audience response system. Areas of agreement and areas of continuing dissent were recorded.

Conclusions: All 5 working groups agreed that a major barrier to advancement of the field of SI/SB research and the development of new treatments for SI/SB remains the lack of a universally accepted standardized nomenclature and classification system. Achieving alignment on definitions and classification of suicide-related phenomena is critical to improving the detection and assessment of SI/SB, the design of clinical trials for new treatments, and effective public health interventions.

Consistency checks to improve measurement with the Positive and Negative Syndrome Scale (PANSS)

Jonathan Rabinowitz , Nina R Schooler, Ariana Anderson, Lindsay Ayearst, David Daniel, Michael Davidson, Anzalee Khan, Bruce Kinon, Francois Menard, Lewis Opler, Mark Opler, Joanne B Severe, David Williamson, Christian Yavorsky, Jun Zhao, ISCTM ALGORITHMS/FLAGS TO IDENTIFY CLINICAL INCONSISTENCY IN THE USE OF RATING SCALES IN CNS RCTs working group members
Schizophrenia Research article/S0920-9964(17)30141 (Open Access)
International Society for CNS Clinical Trials and Methodology convened an expert working-group that assembled consistency/inconsistency flags for the Positive and Negative Syndrome Scale (PANSS). Twenty-four flags were identified and divided based on extent to which they represent error (Possibly, Probably, Very probably or definitely). The flags were applied to assessments derived from the NEWMEDS data repository and the CATIE clinical trial data. Almost 40% of ratings had at least one inconsistency flag raised and 10% had two. Application of flags to clinical rating can improve reliability and validity of trials.