Neuropsynchro
Spain
History
The Network emerged from spontaneous collaboration with the International Society for CNS Clinical Trials and Methodology (ISCTM), addressing persistent challenges in CNS trials. Founded in 2018, our Network drew inspiration from frameworks like OMERACT, COMET, and COSMIN. It evolved from ECNP’s Experimental Medicines Network into an independent Thematic Working Group in 2022. The group unites experts to standardize outcome strategies, published in the ECNP official Journal in 2024. We started offering educational programs via Knowledge Hub in 2025. Recently, we developed a transdiagnostic neurotherapeutics approach to explore new avenues for advancing clinical outcome research in early-phase CNS drug development.
Since start our Network has advanced consensus-based COS and COA methodologies tailored to neuroscience indications. We published the “7-steps standard process”, and discussed through Seed Sessions on challenges in trials for specific therapeutic areas leading to publications in rare neurodevelopmental diseases and schizophrenia research (in collaboration with ISCTM). Recently, we implemented a consortium-based structure with eight subgroups and three support modules (NEWCOMS). Over the next three years, these subgroups will focus on standard-setting in COA related fields as advanced analytics, cognition, biomarkers and transdiagnostic neurotherapeutics. Furthermore, we will work disseminating good practices and expand educational outreach across the scientific community.
Goals
1
Developing and standardizing new methodologies for Core Outcome Sets (COS) definition and Clinical Outcome Assessments (COAs) selection in early-phase clinical research using consensus-based methods.
2
Promoting the application of standards in drug development in clinical trials by pharmaceutical industry/biotechs and other research groups.
3
Development and implementation of novel transdiagnostic neurotherapeutic approaches in COA/COS research, allowing new therapeutic developments targeting specific constructs outside the conventional disease classification systems.
4
Becoming a key source for COAs Science and for the design of different types of innovative outcomes (ClinROs, PROs, PerfOs, DHTs, ObsrOs, Proxys).
5
Facilitation of the communication between different stakeholders, including regulatory agencies and patient advocacy groups. Advise on methodology for outcomes research to other networks.
6
Offering innovative educational programs to different stakeholders involved in drug development including young scientists. Keep sex and gender approach in all activities.
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
-
2024Zaragoza Domingo et al.
Methods for neuroscience drug development: guidance on standardization of the process for defining clinical outcome strategies in clinical trials
European Neuropsychopharmacology -
2023Zaragoza Domingo et al.
Standards for designing optimal outcomes strategies for drug development – Survey on the challenges in neurosciences
Neuropsychopharmacology -
2021Zaragoza Domingo et al.
Improving the efficiency in the selection of clinical outcomes assessment strategies for early trials
European Neuropsychopharmacology
Courses
Access the ECNP Knowledge Hub where you can find online courses with high-quality lectures from expert speakers, organised by the Networks.
Health outcomes: standards for clinical research in neuroscience
The Clinical Outcomes in Early-Phase Clinical Trials Network organised this ECNP Course, aimed at introducing attendees to the science of health outcomes, including clinical outcomes and endpoints. Registration is no longer possible.
