ReviewNeuroscience applied2026
Clinical trials in neurosciences: Need for standards for innovation on clinical outcomes.
Review in Neuroscience applied, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advances in understanding neurobiological factors underlying neurologic and psychiatric conditions have yet to be adequately translated into successful treatments. In neuroscience therapeutic areas, a high percentage of clinical trials fail to demonstrate safety and efficacy, resulting in a lower innovation index compared to other fields. Developing new treatments requires innovative strategies for outcome decision-making, including tailoring existing instruments or creating novel measurement tools to address validity gaps and capture the clinical benefits of new therapeutic approaches. The interdisciplinary expert group forming the Network on Clinical Outcomes in Early-Phase Clinical Trials within the European College of Neuropsychopharmacology (ECNP) promotes harmonization of outcome research practices to increase the likelihood of identifying safe and effective treatments in neuroscience. Consensus-based recommendations on outcome selection standards were issued to guide researchers designing clinical trials aligned with regulatory agency guidelines (Zaragoza Domingo et al., 2024). This paper highlights two common concerns regarding outcomes in neuroscience clinical trials. First, the availability of reliable, sensitive, and fit-for-purpose (FFP) clinical outcome assessment (COA) tools. In fact, several well-established instruments would not meet current qualification requirements, despite their continued use. Second, instruments validated in one clinical context are being applied to a different condition without confirming validity, compromising content validity and measurement properties. A 7-step standard framework is presented to operationalize outcome decisions across early-to-late-phase pharmacological research, reinforcing content validity and psychometric rigour. A recent expert survey broadly endorsed this framework, and future plans include piloting the method across challenging therapeutic fields and engaging regulatory agencies.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.