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20/12/2021 - General information

A guide to accelerate the discovery of new medicines for neurological and psychiatric diseases

The urgent need to find treatments for a large number of degenerative diseases has led a group of experts to develop a guide designed to accelerate new drug discoveries for neurological and psychiatric diseases. Project leads are Dr. Silvia Zaragoza Domingo, consultant and founder of Neuropsynchro, Barcelona, serving as coordinator collaborating with Drs. Jordi Alonso and Montserrat Ferrer, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM) and CIBERESP, and Dr. Manuel de Gracia, Facultat de Psicologia of Universitat de Girona (UdG).

This guide was presented during the 34th Congress of the European Clinical Neurosychopharmacological College (ECNP) in Lisbon on 2-5 October and has been the group's priority project since it was established in 2018.

This work will allow researchers to have more confidence before abandoning drugs during the initial stages of research, particularly in the clinical phases during which if good results are not observed in favor of the new treatment.

The group is composed of experts from Europe, USA, and Canada, including consultants -some of whom are members of the European Medicines Agency (EMA) - who all consider this guide as necessary and relevant.

From this presentation, the guide is available for researchers who are investigating new drugs in clinical phases, so that we will see if the efficiency of trials with patients increases following the recommendations.

From left to right: Silvia Zaragoza, Jordi Alonso, Montse Ferrer and Manuel de Gracia.

This group will also create an external committee of reviewers to provide advice to both independent researchers and pharmaceutical companies. Researchers currently seeking new treatments for diseases within the neurosciences may request a review of their clinical pharmacological development strategy so that they can compare it with committee experts before initiating patient recruitment.

Although the process the group proposes is based on existing knowledge, it constitutes an improvement by providing standard guidelines. This standardization has shown utility in other therapeutic areas (e.g., rheumatology - OMERACT Project) and has been widely promoted in various clinical areas by the COMET initiative in the UK.

In the area of neuroscience, a standardized procedure is needed to improve the efficiency of studies. The method is based on seven steps, which if done completely, could not rule out molecules during the initial stages of research where it is more difficult to detect drug effects.

The guide recommends selecting treatment goals, defining them clearly and at the same time being aligned with the expectations of the patient and his/her family. Until now, the methods followed gave as the only priority the clinical vision of the health professional, this is not to be incorrect, but the possibility is lost that the new treatment will bring improvements that are not detectable with the existing assessment tools in the 'actuality. The use of the procedure suggested in the guide may provide new information that might otherwise be overlooked by sponsors and clinicians during the early stages of research.

The group aims to make the guide accessible to researchers worldwide via a Creative Commons license with the provison that it is not used for profit or commercial exploitation. To give the project sustainability over time, the group is open to receiving public or private funding either by public grants or creating a university chair, supporting the new industrial discoveries of the R&D departments but at the same time maintaining its independence from specific interests of the pharmaceutical industry. The authors acknowledge that the only feasible way to achieve this is if funding is found.

For interested researchers, the group will soon organize training of modules on demand.

Link to the guidance document: https://drive.google.com/file/d/1hbu0WGolZwKcn9CdVP7QNswc7GXawmnr/view?usp=sharing

Link to poster presented at 34t ECNP Congress: https://drive.google.com/file/d/1gjY2AKeTGl8ZXABLx6heZjR8JEzyjLOF/view?usp=sharing

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