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Clinical Outcomes in Early-Phase Clinical Trials

Aiming to enhance the efficiency of early-phase clinical trials in CNS drug development. By promoting the identification, validation, and standardisation of Core Outcome Sets (COS) and Fit-For-Purpose (FFP) Clinical Outcome Assessments (COAs), the network seeks to optimise trial designs and improve outcomes detection. The group fosters collaboration between academia, industry, and regulatory bodies, supporting patient-centric approaches and the development of innovative tools to accelerate drug development.

History

Founded in 2018, the Clinical Outcomes in Early-Phase Clinical Trials Network emerged from discussions between experts at ECNP and the International Society for CNS Clinical Trials and Methodology (ISCTM), driven by concerns over the high failure rates in neuroscience trials. Initially part of the ECNP Experimental Medicines Network under the mentorship of Gerry Dawson, United Kingdom, the group has operated independently from 2022. It has successfully attracted diverse stakeholders, including academic researchers, pharmaceutical companies, service providers, and regulatory agencies, to advance clinical outcome research in early-phase trials. 

Silvia Zaragoza Domingo

Neuropsynchro
Spain

Chair
Bio

Founder and CEO of Neuropsychological Research Organization, S.L. (Neuropsynchro), Barcelona, Spain, a research consulting company focused on CNS clinical trials that is sponsored by the industry and academia, Silvia Zaragoza Domingo is also an independent researcher. Since 2017, she has served as a Clinical Outcomes Assessment (COA) senior scientist in an R&D department in the pharmaceutical industry with a focus on drug development on neuroscience indications.

This Network is the result of her nearly 25 years of experience in international clinical trials, specifically with respect to the attempt to increase the efficiency of clinical research by focusing on translational outcomes. She has proposed a path for mitigating the existing gaps in drug discovery with the aim of improving the accuracy of the selection of clinical outcomes and measurement methods in early trials. Her area of interest is the application of the latest methodological innovations to the measurement of health and the detection of changes produced by therapeutic interventions. She is an active member of the ECNP and the ISCTM.
Core members
Member name Institution City Country
Larry Alphs Larry Alphs Consulting  Princeton, New Jersey  USA
Michael Davidson Nicosia University    Nicosia  Chipre
Franco Di Cesare Leoben Research AURORA  San Vincenzo V.R.  Italy
Georg Dorffner  The Siesta Group Schlafanalyse GmbH  Vienna  Austria
Chris Edgar  Cogstate  London  United Kingdom
Anna-Karin Lundbeck  Valby  Denmark
Josep Maria Haro Abad CIBERSAM  Sant Boi Llobregat  Spain
Susana Ochoa Parc Sanitari Sant Joan de Déu, CIBERSAM  Sant Boi Llobregat  Spain
Rudy Schreiber Maastricht University  Maastricht  The Netherlands
Carles Soriano-Mas University Hospital of Bellvitge  Hospitalet Llobregat  Spain
Daniela Tinocco World Wide Clinical Trials  Barcelona  Spain
Shell members
Member name Institution City Country
Jordi Alonso IMIM  Barcelona  Spain
Peter Annas   Lundbeck  Valby  Denmark
Veleka Allen Sanofi  Bridgewater, NJ  USA
Luke Allen Cambridge Cognition  Cambridge  United Kingdom 
Maria T. Acosta National Human Genome Research Institute (NHGRI)   Bethesda, Maryland  USA
Kim Bishop Global Pharma Consultancy    USA
Florence Butlen-Ducuing EMA  Amsterdam  The Netherlands
Pavel Balabanov EMA  Amsterdam  The Netherlands
Denise Blurry Novartis  Boston  USA
Marc Cantillon Cerecin  Livingston, NJ  USA
Inez Del Cerro Catholic University of Murcia (UCAM)  Murcia  Spain
Gerard R. Dawson P1Vital    Oxfordshire   United Kingdom
David Daniel Signant Health  Virginia  USA
Jenicka Engler Cronos/IQVIA             Boston  USA
Montserrat Ferrer Fores IMIM  Barcelona  Spain 
Kiri Granger Cambridge Cognition  Cambridge  United Kingdom
Manuel de Gracia Universitat de Girona  Girona  Spain
Deborah Hall Heriot-Watt University    Selangor   Malaysia
Brian Harel  Takeda  Cambridge, MA  USA
John Harrison MetisCognition  London  United Kingdom
Pim Heckman Maastricht University  Maastricht  The Netherlands
Bill Horan VeraSci  Durham, NC  USA
Judith Jaeger CognitionMetrics  Stamford, Connecticut  USA
Anzalee Khan Nathan S. Kline Institute  New York  USA
Jan Kottner Charité-Universitätsmedizin  Berlin  Germany
Vanitha Krishna Takeda  New York  USA
Jean-Piera Lindenmayer New York University School of Medicine  New York   USA
Stephen Marder UCLA  Los Angeles  USA
Paul Maruff Cogstate  Melbourne  Australia
Donna Messner Independent Consultant  Washington, DC  USA
Dane McCarrik Sanofi  Leeds  United Kingdom
Nneka Onwudiwe Sanofi  Boston  USA
Amy Pinkham University of Texas  Dallas  USA
Heather Romero Takeda  Rhode Island  USA
Monica Vance Santium  Toronto  Canada
Chris Yavorsky  Valis Bioscience  Berkeley, California  USA

Publications