‘Usage of Decentralisation, Digital health solutions, integration of AI/ML and patient centricity is the way forward in future drug development’


Dr. Shubhadeep Sinha, Senior Vice President, Head -Clinical Development & Medical Affairs (CD&MA), Hetero Labs Limited, in an interview with ETHealthworld’s Rashmi Mabiyan Kaur discusses how the clinical research industry and pharma world are leveraging digitals technologies to improve clinical development. Edited Excerpts:

Q. How have the pharma companies adapted their strategies to address the challenges posed by the pandemic?
The Covid-19 pandemic provided the most challenging circumstances to all stakeholders in clinical development and patient safety including pharmaceutical organisations, regulatory agencies, prescribing doctors & clinical investigators, clinical trial sites, supply chain mechanisms and above all the patients and subjects participating in the clinical studies. The pharma organisations adapted to the challenges by employing patient-centric strategies that included among others decentralised processes, electronic and digital health technologies(DHTs) for efficient clinical trial execution, clinical data management and data integration. This allowed clinical development team to address the challenges due to reduced access to the trial sites, study subjects and resources for clinical trial execution.

During this period, pharmaceutical organisations in India and abroad successfully navigated through several large clinical trials that ensured successful approval of several COVID-19-related products (e.g., Remdesivir, Molnupiravir, Tocilizumab and Covid-19 vaccine etc.). This led to a rapid patient access during the critical stage of COVID-19 pandemic. Studies for other non-Covid indications such as cancer, metabolic diseases, cardiovascular diseases, gastrointestinal diseases etc. were also successfully completed during this period using such ‘patient-centric’ approaches.

Q. Could you tell us about some current trends and challenges in clinical development and how pharma companies in India are addressing these?
The challenges in clinical development are manifold and include both operational and regulatory challenges. The operational challenges of concern include increasingly difficult patient recruitment, generation of credible and valid data, and seamless data integration of globally spread clinical trial sites, without any compromise of patient safety and well-being.

Globally, pharma companies are increasingly employing decentralised trial ( DCT) approach and risk-based monitoring (RBM) (as per ICH and regulatory guidances) using AI enabled DHTs and data management tools. This helps ensure seamless and real-time study management.

In India, similar efforts are underway with increasing usage and implementation of automation and AI-based technologies in clinical trials. The regulatory challenges include a lack of completed guidances to handle emerging DHTs for clinical trials.

Q. How do pharma companies navigate regulatory challenges in clinical development?
Regulatory affairs are the cornerstone for clinical development. All the activities in clinical trials are centred around regulatory guidelines and their compliances, across regions in India and world over. This becomes even stricter in case of novel products, biologics and biosimilars. Pharma organisations in India have implemented electronically enabled Quality management and regulatory affairs management and monitoring systems using validated technologies to address regulatory challenges in pharmaceutical product life cycle including clinical development and pharmacovigilance
activities besides other activities.

Q. In your experience, what role does real-world evidence play in shaping clinical development strategies, and how are companies leveraging this data?
Real-world evidence (RWE) is important for generating continued safety, usage and effectiveness data for the entire post approval life cycle of drug product. This involves various activities such as those prescribed by regulatory agencies including post-authorisation safety and efficacy and active pharmacovigilance programs. Real-world evidence (RWE) also includes long term drug utilization studies, indication expansion studies, extension studies for follow-up of patients who switch after the end of phase-3 studies to standard of care involving the approved drug product(s), target population studies and many more. RWE studies helps generate additional data for continued regulatory compliance, as well.

  • Published On Jan 27, 2024 at 10:30 AM IST

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