Health outcomes: standards for clinical research in neuroscience

1. Comprehensive understanding of outcome definition and validation: The course aims to provide attendees with a comprehensive understanding of the full process of defining outcomes in specific conditions. Participants will learn how to achieve the validation of new tools, ensuring that the measures used in clinical trials accurately capture the intended outcomes. They will gain access to existing resources to find current projects on outcomes research.
2. Patient-focused methodology and clinician evaluation tool: The course will increase awareness of the patient-focused oriented methodology as a complement to current clinician evaluation tools. Attendees will learn how to incorporate the patient's perspective into the outcome definition process, ensuring that the measures used are relevant and meaningful to those affected by the condition. Gain access to libraries of validated instruments.
3. Evaluation tools and digital health technology: Participants will gain an understanding of the different types of evaluation tools available, including the potential of digital health technology to increase the accuracy and temporal resolution of clinical evaluations. This knowledge will enable attendees to select the most appropriate tools for their research and to leverage emerging technologies to enhance the quality of their data collection. 

The course is addressed to clinical researchers who are planning to initiate research on new therapeutic interventions of any kind or research on the validation of devices for research use.

The course is also adequate for different levels of seniority, from young scientists that will learn all these new concepts upon start of the professional path, to more senior clinicians aiming to design investigator's initiated clinical trials.

For the more experienced clinicians, the course will bring new skills and resources useful to their research lines. This course will help clinicians to be in the same page as of pharma researchers i.e. acquiring more competences to obtain resources for their own interventional trials for instance non-pharmacological interventions, new pharmacological interventions or even repurposing of known compounds in new indications. 

The course offers two participation options: E-learning Only and Full Course participation.

For all participants, at both the beginning and conclusion of the course, participants’ knowledge of the subject will be evaluated through a pre-course and post-course test. The course comprises nine 30-minute lectures, which can be accessed at participants’ convenience. Each lecture includes embedded knowledge tests within the recording and concludes with three additional knowledge tests. Following each lecture, a live session will be held, providing an opportunity for participants to interact directly with the lecturers.

As part of the course requirements, participants will prepare an assignment focussing on an outline for a research protocol that focuses on outcomes within their specific therapeutic field.

For those opting for Full Course participation, a half-day in-person meeting will be conducted at the ECNP Congress in Amsterdam, 10 October 2025, during which the research protocol assignments will be reviewed and discussed.

To successfully complete the course, participants are required to:

• View all lectures
• Attend the live sessions
• Complete knowledge tests
• Complete the research protocol assignment
• Participate in the in-person meeting (for full course participants) 

This course runs from February to October 2025. 

Pre-Lecture 0 —Terminology & quiz (S. Zaragoza)  

Lecture 1  — Introductory concepts (S. Zaragoza, L. Alphs)

Lecture 2 — Early versus late-phase stages in drug development (J. Harrison, G. Hernández, Ch. Edgar)  

Lecture 3 — Introduction to the 7-Step standard process for COA strategy (S. Zaragoza, K. Bishop)

Lecture 4 — Step 1 Defining the disease model and impacts (R. Schreiber, M. Ávila, B. Bennett, D. Bury)

Lecture 5 — Step 2-3 Defining the scope for the outcome set & stakeholder involvement (Larry Alphs, M. Markinov)

Lecture 6  — Steps 4 Determining “what” to measure (L. Alphs, B. Bennett, M. Avila)

Lecture 7 — Steps 5 Determining “ how” to measure (Y. Pardo Cladellas, V. Allen, S. Micalo)

Lecture 8 — Steps 6-7 Final generic recommendations COS/COAs in the COU and research roadmap (D. Bury, S. Zaragoza, G. Hernandez

Colloquium: ECNP Amsterdam, Presentation of the best projects

Lecture 9 — Operational recommendations for  measuring clinical outcomes (M. Vance, C. Edgar)

BONUS  

B-LECTURE 1 — RdOC & clinical trials (R. Schreiber, I. Magaraggia)

B-LECTURE 2 — Outcomes in neuropediatric rare diseases (MT. Acosta)

B-LECTURE 3 — AI in biomarker and outcomes research (G. Dorfner)

You can now enrol for this course which is freely accessible to all individuals with a myECNP account. If you do not yet have a myECNP account, please visit the ECNP website at ecnp.eu and navigate to the myECNP tab.

To maximise your experience of the course, we encourage you to apply for Full Course participation. Full Course participants will attend the in-person course meeting on 10 October 2025 in Amsterdam, the Netherlands, held prior to the ECNP 2025 Congress. This meeting offers an opportunity to review and discuss the research protocol assignments, network with fellow participants, and connect with the course organisers. Please note that spaces for Full Course participation are limited and will be allocated based on a brief statement of motivation. 

Should you have any questions, please feel free to contact us at courses@ecnp.eu.