Standardized Pharmaco-EEG in Clinical Development

Context‍

Pharmaco-EEG measures the direct and indirect effects of active compounds on brain activity to evaluate a drug's pharmacodynamic (PD) and pharmacokinetic (PK) properties, its CNS penetration, and its potential therapeutic or toxic effects. By employing standardized methodologies, pharmaco-EEG can serve as a translational biomarker, bridging preclinical research and clinical drug development and aiding in the evaluation of CNS-active compounds in humans.‍

Challenge

The lack of standardization of pharmaco-EEG procedures hinders data comparison and aggregation, impeding the acceptance of EEG-based biomarkers that could help de-risk and accelerate the development of new CNS treatments. ‍

Solution‍

Clouds of Care combines in-house experience with best practices and the IPEG guidelines, assuring standardization and reliability in the recording and evaluation of pharmaco-EEG data throughout our clinical development services:

• ‍Expert Consulting: We provide expert guidance to establish efficient, compliant EEG data collection and analysis processes tailored to the study objectives.‍
• Study Preparation: We develop a detailed EEG charter, defining binding guidelines for standardized data acquisition across participating clinical sites, including equipment requirements (e.g., sampling rates, electrode configuration, etc.) and pharmaco-EEG recording paradigm.‍
• Data Handling and Analysis: We enable the easy and secure transfer of EEG data to our central cloud-based platform, where the data is securely stored, managed, and analyzed.‍
• Data Evaluation and Reporting: We deliver in-depth reports summarizing EEG spectral features, trend analysis, and methodologies, facilitating the interpretation and communication of results to stakeholders.‍
• Project Management: By maintaining direct communication with the participating site(s) and sponsor we ensure seamless collaboration and adherence to timelines.‍

Impact‍

Pharmaco-EEG is gaining recognition as an endpoint for CNS-active drugs, driving its integration into clinical trials and regulatory frameworks. By introducing standardized pharmaco-EEG methodologies, we further enhance the reliability and reproducibility of EEG data analysis, fostering greater confidence in its application across studies. These advancements enable more efficient clinical trials by reducing variability and ultimately lowering costs. As a result, pharmaceutical companies can leverage pharmaco-EEG to accelerate the translation of pre-clinical findings, deepen their understanding of CNS-targeting drugs, fast-track development timelines, and increase their likelihood of success.

Learn more about our pharmaco-EEG experience in clinical development.