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Rising investments in R&D, coupled with the growing prevalence of chronic diseases, are accelerating the expansion of the global clinical trials landscape, with India emerging as a key growth market. Pharmaceutical and biotechnology companies are spurring clinical development to address unmet medical needs, while India’s large patient pool, cost efficiencies, and improving regulatory framework are enhancing its attractiveness as a preferred destination for clinical research, said Dr. Mahesh Bhalgat, Group CEO & MD, Veeda Lifesciences in an email interaction with Nandita Vijayasimha.Excerpts:
How do you view the current scene of clinical trials in India and globally?
The global clinical trials landscape is experiencing robust growth, driven by increasing R&D investments and the rising burden of chronic diseases. India has emerged as a preferred destination for clinical research, conducting over 3,000 trials annually across therapeutic areas.
India’s competitive advantages are compelling: a diverse patient population providing rich epidemiological data, cost efficiencies of 40-50 per cent compared to the US, with APAC region allowing cost reductions in this range according to industry sources, and an established regulatory framework under Central Drugs Standard Control Organisation (CDSCO). The New Drugs and Clinical Trials Rules 2019 established defined approval timelines of 30 working days for drugs developed in India and 90 working days for drugs developed outside India, with deemed approval if no communication is received within these periods.
India has experienced remarkable 80 per cent CAGR from 2019-2024, becoming the third-largest destination for clinical trials globally by 2024, with approximately 18,000 new trials registered in India in 2024, representing 50 per cent growth from the previous year.
However, challenges persist. India faces patient recruitment complexities in tier-2 and tier-3 cities, retention issues, and the need for enhanced site infrastructure. Globally, regulatory harmonization remains a work in progress. Nevertheless, India’s skilled investigators, good clinical practice compliance, and improving digital infrastructure position it favourably for continued growth in the future.
What are the visible trends that you see?
Several transformative trends are reshaping clinical research:
To begin with, patient-centricity has moved from concept to imperative. In India, the government established Telemedicine Practice Guidelines in 2020, enabling remote healthcare delivery. However, adoption varies by region and therapeutic area.
Decentralized and hybrid trials have gained foothold. Globally, hybrid trials became the preferred model in 2024, with 77 per cent of trials using this approach. In India, pilot decentralized trials face infrastructure challenges including untrained staff for decentralization operations and absence of e-consent provisions in New Drugs and Clinical Trial Rules 2019. However, India is developing a growing ecosystem of digital health platforms and remote monitoring tools, with increasing adoption among hospital sites and CROs.
The regulatory convergence is accelerating. The EU-US Mutual Recognition Agreement on pharmaceutical GMP inspections has been in force since November 2017. The EU engages in regulatory dialogue with India via the EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical Devices, based on the 1994 Cooperation Agreement
The therapeutic diversification is evident, with oncology, rare diseases, and cell-gene therapies dominating pipelines. India registered 18,000 new trials in 2024, marking 50 per cent year-over-year increase, demonstrating significant volume growth. Precision medicine approaches require smaller, biomarker-selected populations rather than large traditional cohorts.
The real-world evidence integration is supplementing traditional Randomized Controlled Trials. Regulatory agencies now accept Real-World Evidence for label expansions and post-marketing surveillance.
These trends collectively promise faster, more efficient trials that better serve patients while maintaining scientific rigour and regulatory compliance.
In clinical research segment, how much of tech implementation is accelerating human studies?
Technology has fundamentally transformed clinical trial velocity and efficiency. What once required years now advances in months through intelligent digital integration. For instance, Electronic Data Capture and Electronic Trial Master Files eliminate paper-based delays, enabling real-time data access. EDC adoption has reduced data query rates from 25 per cent to one per cent when switching from paper to electronic systems.
The use of Artificial Intelligence accelerates patient recruitment. Patient recruitment tools improved enrolment rates by 65 per cent, with predictive analytics models achieving 85 per cent accuracy in forecasting trial outcomes. AI-powered study builds reduced EDC setup timelines from 10-12 weeks to just a few days.
Wearable devices and IoT (Internet of Things) sensors provide continuous, objective data streams replacing periodic clinic assessments. This enhances data quality while reducing patient burden.
Risk-based monitoring platforms use analytics to identify sites requiring intervention, optimizing resource allocation.
The cumulative impact is substantial as clinical : trial timelines have reduced, patient recruitment process and data quality improved significantly. However, technology is an enabler, not replacement, for human expertise. Successful implementation requires balancing innovation with regulatory compliance, data privacy, and the irreplaceable human elements of patient care and scientific judgment.
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