{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:42:11Z","timestamp":1760146931265,"version":"build-2065373602"},"reference-count":19,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T00:00:00Z","timestamp":1734998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Italian Ministry of Health","award":["RF-2021-12374979","DN. 1553 11.10.2022"],"award-info":[{"award-number":["RF-2021-12374979","DN. 1553 11.10.2022"]}]},{"name":"#NEXTGENERATIONEU (NGEU)","award":["RF-2021-12374979","DN. 1553 11.10.2022"],"award-info":[{"award-number":["RF-2021-12374979","DN. 1553 11.10.2022"]}]},{"name":"Ministry of University and Research (MUR)","award":["RF-2021-12374979","DN. 1553 11.10.2022"],"award-info":[{"award-number":["RF-2021-12374979","DN. 1553 11.10.2022"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neurology International"],"abstract":"<jats:p>Background\/Objectives: Drug development involves multiple stages, spanning from initial discovery to clinical trials. This intricate process entails understanding disease mechanisms, identifying potential drug targets, and evaluating the efficacy and safety of candidate drugs. Clinical trials are designed to assess the effects of drugs on humans, focusing on determining safety profiles, appropriate modes of administration, and comparative efficacy against placebos. Notably, neuroscience drug development encounters distinct challenges, including the complex nature of diseases, limitations imposed by the blood\u2013brain barrier, the absence of reliable predictive preclinical models, and regulatory hurdles. Ethical and safety considerations are pivotal due to the potential cognitive and motor effects of CNS-active drugs. Methods: Our manuscript outlines the procedures for CNS clinical trials and highlights the key elements of study design, methodological considerations, and ethical frameworks. To achieve our objectives, we considered the official websites of regulatory authorities, the EQUATOR network, and recent publications in the field. The paper includes key elements such as criteria for subject selection, methods of evaluation, variable analysis, and statistical methodology approaches. Results: We want to furnish a concise and comprehensive guide tailored to individuals new to CNS clinical trials, providing foundational elements necessary for the design and execution of such trials. The manuscript seeks to outline sources of relevant materials and elucidate adaptability, particularly in instances where sponsors may be absent. Conclusions: By meeting the needs of less-experienced researchers or those with limited resources, the intention is to facilitate an understanding of the intricate nature of the process and offer guidance on appropriately navigating its complexities. It is essential to note that this manuscript does not aim to be exhaustive but endeavors to serve as a structured checklist. Through its approach, the manuscript aspires to offer guidance and support to individuals navigating the challenges inherent in this intricate domain.<\/jats:p>","DOI":"10.3390\/neurolint17010001","type":"journal-article","created":{"date-parts":[[2024,12,24]],"date-time":"2024-12-24T09:00:57Z","timestamp":1735030857000},"page":"1","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Leaflet: Operative Steps for Interventional Studies in Neuroscience"],"prefix":"10.3390","volume":"17","author":[{"given":"Maria","family":"Meringolo","sequence":"first","affiliation":[{"name":"Santa Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy"},{"name":"Faculty of Medicine and Surgery, Saint Camillus International University of Health and Medical Sciences, 00131 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4210-2545","authenticated-orcid":false,"given":"Sergio","family":"Delle Monache","sequence":"additional","affiliation":[{"name":"Santa Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy"},{"name":"Department of Systems Medicine and Centre of Space Bio-Medicine, University of Rome Tor Vergata, 00133 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8927-7107","authenticated-orcid":false,"given":"Giuseppina","family":"Martella","sequence":"additional","affiliation":[{"name":"Santa Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy"},{"name":"Department of Psychology and Health Sciences, Faculty of Humanities Educations and Sports, Pegaso Telematics University, 80143 Naples, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonella","family":"Peppe","sequence":"additional","affiliation":[{"name":"Santa Lucia Foundation, IRCCS Fondazione Santa Lucia, 00179 Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,12,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"651","DOI":"10.1016\/j.trci.2017.10.005","article-title":"Drug Discovery and Development: Role of Basic Biological Research","volume":"3","author":"Mohs","year":"2017","journal-title":"Alzheimers Dement. 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