[HTML][HTML] Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials

SZ Domingo, J Alonso, M Ferrer, MT Acosta… - European …, 2024 - Elsevier
Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate
outcomes selection in early clinical trials is key to maximizing the likelihood of identifying …

Clinical pharmacology in neuroscience drug discovery: quo vadis?

DG Trist, A Cohen, A Bye - Current Opinion in Pharmacology, 2014 - Elsevier
Highlights•Clinical Pharmacology is an essential part of the Neurosciences Drug Discovery
process.•In recent years there has been an emphasis on First Time in Human safety and …

[HTML][HTML] Failed trials for central nervous system disorders do not necessarily invalidate preclinical models and drug targets

A Bespalov, T Steckler, B Altevogt, E Koustova… - Nature Reviews Drug …, 2016 - nature.com
A recent article identified five key technical determinants that make substantial contributions
to the outcome of drug R&D projects (Lessons learned from the fate of AstraZeneca's drug …

[图书][B] Clinical trials in neurology: design, conduct, analysis

B Ravina, M McDermott - 2012 - books.google.com
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials
in Neurology aims to improve the efficiency of clinical trials and the development of …

Strategies to address challenges in neuroscience drug discovery and development

P O'Donnell, L Rosen, R Alexander… - International Journal …, 2019 - academic.oup.com
The paucity of novel drugs for neuropsychiatric indications contrasts with the remarkable
recent advances in neuroscience research. We have identified 5 challenges the field needs …

[图书][B] Clinical trials in psychopharmacology: a better brain

M Hertzman, L Adler - 2010 - books.google.com
Although clinical trials were virtually unheard of in psychiatry for many years, they are now
the gold standard for judging whether drugs are safe and useful. But should they be? What …

Concerns about clinical drug trials

DS Robinson, K Rickels - Journal of Clinical Psychopharmacology, 2000 - journals.lww.com
There is growing awareness among many in the pharmaceutical industry and research
community that psychopharmacologic drug development is approaching a crisis because of …

Innovative trends in the design of therapeutic trials in psychopharmacology and psychotherapy

GA Fava, E Tomba, E Tossani - Progress in Neuro-Psychopharmacology …, 2013 - Elsevier
The standard randomized controlled trial design is still based on the acute disease model.
This is in sharp contrast with the fact that the patient is likely to have experienced other …

Designing clinically useful psychopharmacological trials: challenges and ways forward

A Chevance, P Ravaud, V Cornelius… - The Lancet …, 2022 - thelancet.com
The clinical guidelines that underpin the use of drugs for mental disorders are informed by
evidence from randomised controlled trials (RCTs). RCTs are performed to obtain marketing …

The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de‐risk trial programmes of novel agents

CU Correll, M Solmi, S Cortese, M Fava… - World …, 2023 - Wiley Online Library
Despite considerable progress in pharmacotherapy over the past seven decades, many
mental disorders remain insufficiently treated. This situation is in part due to the limited …