A leading pharmaceutical company based in India, renowned for its advancements in “Specialty Nanotherapeutics,” is committed to research and development of innovative treatments, with a particular focus on central nervous system (CNS) disorders. The client approached Techsol’s expertise to develop a clinical trial protocol for a phase III CNS-targeted psychiatric product, ensuring compliance with ICH E6 R2 guidelines and NDCT 2019 regulatory standards.

Project Objective: 

The objective was to define the key components of the protocol for executing the clinical trial in India. This included calculating the Human Equivalent Dose (HED), as the API has established pre-clinical data for dose determination, and developing psychiatric scales for clinical assessments to ensure the smooth execution of the trial and achievement of its overarching goals. 

Techsol Approach:  

This involved a deep understanding of the client requirements and regulatory expectations, emphasizing the distinct aspects of CNS-focused therapeutics and specific challenges posed by psychiatric disorders. Techsol medical writing team conducted a systematic literature search, combined with a review of CTRI trial data to develop a robust trial protocol that aligned with the study objectives. Techsol’s in-house Toxicologists calculated HED, using industry-standard methodologies to ensure appropriate dosing, scientific rigor and patient safety. Recognizing the need for precise and sensitive psychiatric evaluations, Techsol’s team developed and validated specialized psychiatric scales for clinical evaluations.

• Regulatory Complexity: Ensuring compliance with both ICH E6 R2 international guidelines and India’s NDCT 2019 standards have unique and stringent requirements for CNS and psychiatric products.
• Dose Translation Accuracy: Calculating Human Equivalent Dose (HED) precisely from preclinical data, poses a vital challenge for ensuring patient safety and securing regulatory approval after animal model trials.
• Psychiatric Assessment Sensitivity: Developing psychiatric scales that can accurately capture complex CNS disorder symptoms poses a challenge for developing protocol.

Techsol innovative and crucial solutions:  

• Techsol’s medical writing and regulatory experts meticulously reviewed regulatory guidelines and ensured compliance to streamline a path to regulatory acceptance for both international and local standards. This included designing the protocol with precise eligibility criteria, study design and endpoints.
• Techsol’s toxicology expert team used an advanced dose-conversion algorithm to translate animal model data into a clinically relevant human dose. This was validated through iterative calculations and expert review to ensure dosing was scientifically sound, minimizing risk and optimizing therapeutic outcomes.
• Our medical experts selected appropriate assessment scales for CNS-related psychiatric trials, leveraging insights from Key Opinion Leaders (KOLs) and conducting an extensive literature review with accuracy and patient safety. The scales included GAD-7 and HAM-A for measuring anxiety severity, CGI-I for evaluating overall improvement, and PSQI for assessing changes in condition and sleep quality. These scales were designed to capture the CNS-related psychiatric symptoms, enhancing the precision of clinical assessments and ensuring data quality.
• Our team developed a robust and feasible study design, clearly outlining the study objectives, inclusion/exclusion criteria, treatment groups, and endpoints. By conducting comprehensive risk assessments, our team developed a detailed activity schedule along with safety protocols to be adhered to throughout the study.

Project Achievements: 

Through Techsol’s rigorous and client-centered approach, resulted in the following achievements:  

• Regulatory Approval: The protocol successfully achieved regulatory approval, demonstrating compliance with both ICH E6 R2 and NDCT 2019 requirements.
• Optimized and Safe Dosing Strategy: The precise HED calculation established a dosing framework that prioritized patient safety while ensuring therapeutic benefit.
• Accurate Psychiatric Assessment Tools: The custom-developed psychiatric scales allowed for sensitive and reliable assessments, significantly enhancing data accuracy and the potential for meaningful clinical insights.

 

Study Outcomes: 
Techsol’s expertise in developing a clinical trial protocol for a psychiatric treatment in the CNS domain. The team’s strategic and thorough approach ensured compliance with complex regulatory standards, optimized dose translation, and enabled precise psychiatric assessment. This successful collaboration positioned the client for a smooth clinical trial process and laid a strong foundation for potential future approval and market entry of a much-needed psychiatric therapeutic.
Benefits for the Client: 
The project yielded significant benefits for the client:

• Obtaining authorization from the Drug Controller General of India (DCGI) for the proposed protocol.
• Seamless implementation of the trial, free from complications or modifications, showcasing the strength of the protocol design.  
• Accomplishment of the phase III clinical trial, meeting its goals and illustrating the success of the project.